IXT5: Trial of Overminus Spectacle Therapy for Intermittent Exotropia

• Sponsor: Jaeb Center for Health Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT02807350
• Collaborator: Pediatric Eye Disease Investigator Group (Other), National Eye Institute (NEI) (NIH)
• Enrollment: 386
• Locations: 61
• Arms: 2
• Actual Duration (Months): 61
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine:

• The long-term on-treatment effect of overminus treatment on distance intermittent exotropia (IXT) control score.

• The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).

Condition or Disease	Intervention/Treatment	Phase
Intermittent Exotropia	Device: Overminus treatment; Device: Non-overminus treatment	N/A

Detailed Description

The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine:

• The long-term on-treatment effect of overminus treatment on distance IXT control score.

• The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).

The recently completed IXT3 pilot study (NCT02223650) addressed the question of whether overminus lens therapy has an initial short-term therapeutic effect for IXT while wearing overminus spectacles. There have been no rigorous studies that address the following important questions related to overminus lens therapy:

• Does overminus lens therapy have a long-term therapeutic effect for IXT while wearing overminus spectacles (over many months or years)?

• Does overminus lens therapy have a long-term therapeutic effect for IXT when overminus spectacles are discontinued?

In November 2019, a protocol amendment discontinued overminus lens treatment and extended the study for an additional 18 months after the 18-month randomized trial has ended. The objective of the extension study is to compare long-term refractive error between subjects originally treated with either overminus spectacles or non-overminus spectacles as part of the 18-month randomized trial; treatment is at investigator discretion.

Study Design

• Study Type: Interventional
• Actual Enrollment: 386 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
• Actual Study Start Date: Jan 16, 2017
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Feb 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Overminus Treatment spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	Device: Overminus treatment; spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere; Other Names: Overminus spectacles Overminus glasses Overminus therapy
Active Comparator: Non-overminus Treatment spectacles with full cycloplegic refraction without overminus	Device: Non-overminus treatment; spectacles with full cycloplegic refraction without overminus

Outcome Measures

Primary Outcome Measures

1. Mean Distance Control at 12-Months (On-Treatment Visit) [12 months]

   A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).

2. Mean Distance Control at 18-Months (Off-Treatment Visit) [18 months]

   A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50D overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 18 months (after treatment discontinuation). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).

Secondary Outcome Measures

1. Number of Participants With No Spontaneous Tropia [12 months]

   The number of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.

2. No Spontaneous Tropia [At 18 months]

   The proportion of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.

3. Change in Distance Control [12 months]

   The proportion of subjects with ≥1 point improvement in distance control between baseline and 12 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).

4. Change in Distance Control [18 months]

   The proportion of subjects with ≥1 point improvement in distance control between baseline and 18 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).

5. Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months) [12 months]

   The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.

6. Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months) [18 months]

   The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.

7. Near Control (12 Months) [12 months]

   Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).

8. Near Control (18 Months) [18 months]

   Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).

9. Change in Near Control (12 Months) [12 months]

   For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).

10. Change in Near Control (18 Months) [18 months]

    For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).

11. Angle Magnitude (12 Months) [12 months]

    The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.

12. Angle Magnitude (18 Months) [18 months]

    The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.

13. Stereoacuity at 12 Months [12 months]

    A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.

14. Stereoacuity at 18 Months [18 months]

    A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.

15. Compliance With Spectacle Wear (12 Months) [12 months]

    Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.

16. Compliance With Spectacle Wear (18 Months) [18 months]

    Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.

17. Parent Symptom Survey [12 Months] [At 12 months]

    A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.

18. Parent Symptom Survey [18 Months] [At 18 months]

    A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 3 years to < 11 years

• Intermittent exotropia (manifest deviation) meeting all of the following criteria:

• At distance: intermittent exotropia or constant exotropia

o Mean distance control score of 2 points or more (mean of 3 assessments over the exam)

• At near: intermittent exotropia, exophoria, or orthophoria

o Subject cannot have a score of 5 points on all 3 near assessments of control

• Exodeviation at least 15∆ at distance measured by PACT

• Near deviation does not exceed distance deviation by more than 10∆ by PACT (convergence insufficiency type IXT excluded)

• Distance visual acuity (any optotype method) in each eye of 0.4 logMAR (20/50) or better if age 3 years and 0.3 logMAR (20/40) or better if 4 years or older.

• Interocular difference of distance visual acuity ≤0.2 logMAR (2 lines on a logMAR chart)

• Refractive error between -6.00 diopters (D) standard error (SE) and +1.00D SE (inclusive) in the most myopic / least hyperopic eye based on a cycloplegic refraction performed within the past 2 months or at the end of the enrollment exam.

• If refractive error (based on cycloplegic refraction performed within past 2 months or at the end of the enrollment exam) meets any of the following criteria, then pre-study spectacles are required and must have been worn for at least 1 week prior to enrollment:

• SE anisometropia ≥1.00D

• Astigmatism ≥1.50D in either eye

• SE myopia ≥-1.00D in either eye

Pre-study refractive correction, if worn, must meet the following criteria relative to the cycloplegic refraction performed within past 2 months or at the end of the enrollment exam:

• SE anisometropia must be corrected within <1.00D of the SE anisometropic difference

• Astigmatism must be corrected within <1.00D of full magnitude; axis must be within 10 degrees.

• The SE of the spectacles must not meet the definition of substantial overminus (see exclusion criteria below)

• Gestational age ≥ 32 weeks

• Birth weight > 1500 grams

• Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus spectacles

• Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff and Investigator's site staff

• Relocation outside of area of an active PEDIG site within next 18 months is not anticipated

Exclusion Criteria:

• Treatment for IXT or amblyopia (other than refractive correction) within the past 4 weeks, including vision therapy, patching, atropine, or other penalization.

• Current contact lens wear

• Substantial deliberate overminus treatment within the past 6 months, defined as spectacles overminused by more than 1.00D SE than the cycloplegic refractive error (within 2 months or at the end of the enrollment exam)

• Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)

• Abnormality of the cornea, lens, or central retina

• Down syndrome or cerebral palsy

• Severe developmental delay which would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delays or reading and/or learning disabilities are not excluded.

• Any disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, dysautonomia, myasthenia gravis, or current use of atropine for amblyopia

• Anti-seizure medications [e.g., carbamazepine (Tegretol, Carbatrol, Epitol, or Equetro), diazepam (Valium or Diastat), clobazam (Frisium or Onfri), clonazepam (Klonopin), lorazepam (Ativan), ethosuximide (Zarontin), felbamate (Felbatol), lacosamide (VIMPAT), gabapentin (Neurontin), oxcarbazepine (Oxtellar XR or Trileptal), phenobarbital, phenytoin (Dilantin or Phenytek), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote), or zonisamide (Zonegran), vigabatrin (Sabril)]

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Midwestern University Eye Institute	Glendale	Arizona	United States	85308
3	Arkansas Childrens	Little Rock	Arkansas	United States	72202
4	University Eye Center at Ketchum Health	Anaheim	California	United States	92807
5	Marshall B. Ketchum University	Fullerton	California	United States	92831
6	Loma Linda University Health Care, Dept. of Ophthalmology	Loma Linda	California	United States	92354
7	Saddleback Eye Medical Associates	Mission Viejo	California	United States	92691
8	Stanford University	Palo Alto	California	United States	94303
9	Western University College of Optometry	Pomona	California	United States	91766
10	University of California San Francisco Department of Ophthalmology	San Francisco	California	United States	94143
11	Nova Southeastern University College of Optometry, The Eye Institute	Fort Lauderdale	Florida	United States	33382
12	University of Florida Shands Hospital	Gainesville	Florida	United States	32608
13	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
14	The Emory Eye Center	Atlanta	Georgia	United States	30322
15	St Luke's Hospital	Boise	Idaho	United States	83702
16	The Eye Specialists Center, LLC	Chicago Ridge	Illinois	United States	60415
17	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
18	Illinois College of Optometry	Chicago	Illinois	United States	60616
19	Midwestern U Chicago College of Optometry	Downers Grove	Illinois	United States	60515
20	Pediatric Eye Associates	Wilmette	Illinois	United States	60091
21	Indiana University School Of Optometry	Bloomington	Indiana	United States	47405
22	Riley Hospital for Children	Indianapolis	Indiana	United States	46202
23	The Eye Specialist Center, LLC	Munster	Indiana	United States	46321
24	Wolfe Eye Clinic	West Des Moines	Iowa	United States	50266
25	University of Kentucky Department of Neurology	Lexington	Kentucky	United States	40536
26	Greater Baltimore Medical Center	Baltimore	Maryland	United States	21204-5809
27	Wilmer Eye Institute	Baltimore	Maryland	United States	21287-9028
28	Tufts Medical Center	Boston	Massachusetts	United States	02111
29	Boston Medical Center	Boston	Massachusetts	United States	02118
30	Helen DeVos Children's Hospital Pediatric Ophthalmology	Grand Rapids	Michigan	United States	49503
31	Pediatric Ophthalmology, P.C.	Grand Rapids	Michigan	United States	49546
32	Children's Eye Care PC	West Bloomfield	Michigan	United States	48322
33	University of Minnesota	Minneapolis	Minnesota	United States	55454
34	Mayo Clinic Department of Ophthalmology	Rochester	Minnesota	United States	55905
35	Children's Mercy Hospitals and Clinics	Kansas City	Missouri	United States	64108
36	U of MO St. Louis College of Optometry	Saint Louis	Missouri	United States	63121
37	University of Nebraska Medical Center	Omaha	Nebraska	United States	68114
38	Concord Ophthalmologic Associates	Concord	New Hampshire	United States	03301
39	State University of New York, College of Optometry	New York	New York	United States	10036
40	Duke University Eye Center	Durham	North Carolina	United States	27710
41	Akron Children's Hospital	Akron	Ohio	United States	44308
42	Cincinnati Children's Hospital	Cincinnati	Ohio	United States	45229
43	The Ohio State University College of Optometry	Columbus	Ohio	United States	43210-1280
44	Eye Care Associates, Inc.	Poland	Ohio	United States	44514
45	Dean A. McGee Eye Institute, University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
46	Pacific University College of Optometry	Portland	Oregon	United States	97205
47	Casey Eye Institute	Portland	Oregon	United States	97239
48	Conestoga Eye	Lancaster	Pennsylvania	United States	17601
49	Salus University/Pennsylvania College of Optometry	Philadelphia	Pennsylvania	United States	19141
50	UPMC Children's Eye Center of Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224
51	Medical University of South Carolina, Storm Eye Institute	Charleston	South Carolina	United States	29425
52	Pediatric Eye Specialists	Chattanooga	Tennessee	United States	37421
53	Southern College of Optometry	Memphis	Tennessee	United States	38104
54	Texas Children's Hospital - Dept. Of Ophthalmology	Houston	Texas	United States	77030
55	University of Houston College of Optometry	Houston	Texas	United States	77204
56	Texas Tech University Health Science Center	Lubbock	Texas	United States	79430
57	Houston Eye Associates	The Woodlands	Texas	United States	77381
58	Virginia Pediatric Eye Center	Norfolk	Virginia	United States	23502
59	Gundersen Health System	La Crosse	Wisconsin	United States	54601
60	Alberta Children's Hospital	Calgary	Alberta	Canada
61	CHU - Sainte-Justine	Montreal	Quebec	Canada	H3T 1C5

Sponsors and Collaborators

• Jaeb Center for Health Research
• Pediatric Eye Disease Investigator Group
• National Eye Institute (NEI)

Investigators

• Study Chair: Angela M Chen, OD, MS, Marshall B. Ketchum University
• Study Chair: S. Ayse Erzurum, MD, Eye Care Associates, Inc.

Study Documents (Full-Text)

• Study Protocol - Nov 22, 2019
• Statistical Analysis Plan - Feb 25, 2021
• Informed Consent Form - Dec 18, 2019

More Information

Additional Information:

• PEDIG public website

Publications

None provided.

• Responsible Party: Jaeb Center for Health Research
• ClinicalTrials.gov Identifier: NCT02807350
• Other Study ID Numbers: IXT5; 2U10EY011751
• First Posted: Jun 21, 2016
• Last Update Posted: Jun 3, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Jaeb Center for Health Research: Intermittent Exotropia; IXT; overminus
• Additional relevant MeSH terms: Exotropia

Study Results

Participant Flow

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Period Title: Overall Study
STARTED	196	190
6 mo Follow Up Visit	188	171
12 mo Follow Up Visit	189	169
15 mo Follow Up Visit	180	153
COMPLETED	176	155
NOT COMPLETED	20	35

Baseline Characteristics

Arm/Group Title	Overminus Treatment	Non-overminus Treatment	Total
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus	Total of all reporting groups
Overall Participants	196	190	386
Age, Customized (Count of Participants)
3 to <7 years	123 62.8%	120 63.2%	243 63%
7 to <11 years	73 37.2%	70 36.8%	143 37%
Sex: Female, Male (Count of Participants)
Female	112 57.1%	114 60%	226 58.5%
Male	84 42.9%	76 40%	160 41.5%
Race/Ethnicity, Customized (Count of Participants)
Asian	6 3.1%	10 5.3%	16 4.1%
Black/African American	34 17.3%	28 14.7%	62 16.1%
Hispanic	31 15.8%	40 21.1%	71 18.4%
White	113 57.7%	91 47.9%	204 52.8%
Other	12 6.1%	21 11.1%	33 8.5%
Refractive Error (Count of Participants)
>0.50 Diopters	58 29.6%	59 31.1%	117 30.3%
>-0.75 to 0.50 Diopters	101 51.5%	96 50.5%	197 51%
-0.75 to >-3.00 Diopters	29 14.8%	32 16.8%	61 15.8%
<=-3.00 Diopters	8 4.1%	3 1.6%	11 2.8%
Prior Non Surgical Treatment of IXT (Count of Participants)
None	126 64.3%	137 72.1%	263 68.1%
Patching only	53 27%	33 17.4%	86 22.3%
Vision therapy only	10 5.1%	11 5.8%	21 5.4%
Patching plus other	4 2%	6 3.2%	10 2.6%
Other	3 1.5%	3 1.6%	6 1.6%
Randot Preschool Stereoacuity test score at near (Count of Participants)
40-100 arcseconds	120 61.2%	112 58.9%	232 60.1%
200-800 arcseconds	52 26.5%	55 28.9%	107 27.7%
Nil	16 8.2%	16 8.4%	32 8.3%
Mean distance visual acuity (Count of Participants)
20/12 to 20/20	115 58.7%	112 58.9%	227 58.8%
20/25 to 20/32	70 35.7%	69 36.3%	139 36%
20/40 to 20/50	11 5.6%	9 4.7%	20 5.2%
IOD of distance visual acuity (Count of Participants)
0 lines	130 66.3%	115 60.5%	245 63.5%
0.1 lines	57 29.1%	61 32.1%	118 30.6%
0.2 lines	9 4.6%	14 7.4%	23 6%
Spectacle wear (Count of Participants)
Does not wear spectacles	140 71.4%	142 74.7%	282 73.1%
Wearing spectacles for at least 1 week	56 28.6%	48 25.3%	104 26.9%
Exotropia Control at Distance (Count of Participants)
0 to <1 points	NA NaN	NA NaN	NA NaN
1 to <2 points	NA NaN	NA NaN	NA NaN
2 to <3 points	84 42.9%	78 41.1%	162 42%
3 to <4 points	56 28.6%	52 27.4%	108 28%
4 to 5 points	56 28.6%	60 31.6%	116 30.1%
Exotropia Control at near (Count of Participants)
0 to <1 points	37 18.9%	46 24.2%	83 21.5%
1 to <2 points	80 40.8%	65 34.2%	145 37.6%
2 to <3 points	39 19.9%	44 23.2%	83 21.5%
3 to <4 points	31 15.8%	27 14.2%	58 15%
4 to 5 points	9 4.6%	8 4.2%	17 4.4%
PACT exodeviation at distance (Count of Participants)
No exodeviation (orthophoria)	NA NaN	NA NaN	NA NaN
1-9 Δ	NA NaN	NA NaN	NA NaN
10-15 Δ	5 2.6%	6 3.2%	11 2.8%
16-18 Δ	42 21.4%	22 11.6%	64 16.6%
19-25 Δ	86 43.9%	91 47.9%	177 45.9%
30-35 Δ	54 27.6%	50 26.3%	104 26.9%
40-45 Δ	9 4.6%	19 10%	28 7.3%
>= 50 Δ	0 0%	2 1.1%	2 0.5%
Esodeviation	NA NaN	NA NaN	NA NaN
PACT Exodeviation at near (Count of Participants)
No Exodeviation (orthophoria)	2 1%	3 1.6%	5 1.3%
1-9 Δ	27 13.8%	24 12.6%	51 13.2%
10-15 Δ	45 23%	45 23.7%	90 23.3%
16-18 Δ	36 18.4%	29 15.3%	65 16.8%
19-25 Δ	57 29.1%	59 31.1%	116 30.1%
30-35 Δ	24 12.2%	21 11.1%	45 11.7%
40-45 Δ	4 2%	8 4.2%	12 3.1%
>= 50 Δ	1 0.5%	0 0%	1 0.3%
Esodeviation	0 0%	1 0.5%	1 0.3%

Outcome Measures

1. Primary Outcome

Title	Mean Distance Control at 12-Months (On-Treatment Visit)
Description	A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	189	169
Mean (Standard Deviation) [points]	1.8 (1.3)	2.8 (1.5)

2. Primary Outcome

Title	Mean Distance Control at 18-Months (Off-Treatment Visit)
Description	A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50D overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 18 months (after treatment discontinuation). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	176	155
Mean (Standard Deviation) [points]	2.4 (1.5)	2.7 (1.6)

3. Secondary Outcome

Title	Number of Participants With No Spontaneous Tropia
Description	The number of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	189	169
Count of Participants [Participants]	115 58.7%	62 32.6%

4. Secondary Outcome

Title	No Spontaneous Tropia
Description	The proportion of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
Time Frame	At 18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	176	155
Count of Participants [Participants]	85 43.4%	60 31.6%

5. Secondary Outcome

Title	Change in Distance Control
Description	The proportion of subjects with ≥1 point improvement in distance control between baseline and 12 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	189	169
>1 Point	116 59.2%	71 37.4%
>2 Points	65 33.2%	24 12.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overminus Treatment
	Comments	>1 point analysis
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	19
	Confidence Interval	(2-Sided) 95%; 7 to 29
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Overminus Treatment
	Comments
	Type of Statistical Test	Other
	Comments	>2 points analysis
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	20
	Confidence Interval	(2-Sided) 95%; 10 to 28
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change in Distance Control
Description	The proportion of subjects with ≥1 point improvement in distance control between baseline and 18 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	176	155
>1 Point	86 43.9%	68 35.8%
>2 Points	48 24.5%	30 15.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overminus Treatment
	Comments
	Type of Statistical Test	Other
	Comments	>1 analysis
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	4
	Confidence Interval	(2-Sided) 95%; -7 to 15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Overminus Treatment
	Comments
	Type of Statistical Test	Other
	Comments	>2 analysis
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	8
	Confidence Interval	(2-Sided) 95%; -2 to 17
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months)
Description	The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	189	169
Count of Participants [Participants]	5 2.6%	7 3.7%

8. Secondary Outcome

Title	Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months)
Description	The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	176	155
Count of Participants [Participants]	6 3.1%	16 8.4%

9. Secondary Outcome

Title	Near Control (12 Months)
Description	Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	189	169
0 to <1 points	96 49%	64 33.7%
1 to <2 points	59 30.1%	55 28.9%
2 to <3 points	21 10.7%	13 6.8%
3 to <4 points	9 4.6%	17 8.9%
4 to 5 points	4 2%	20 10.5%

10. Secondary Outcome

Title	Near Control (18 Months)
Description	Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	176	155
0 to <1 points	72 36.7%	59 31.1%
1 to <2 points	60 30.6%	46 24.2%
2 to <3 points	16 8.2%	18 9.5%
3 to <4 points	15 7.7%	16 8.4%
4 to 5 points	13 6.6%	16 8.4%

11. Secondary Outcome

Title	Change in Near Control (12 Months)
Description	For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	189	169
Mean (Standard Deviation) [points]	0.7 (1.3)	0.1 (1.4)

12. Secondary Outcome

Title	Change in Near Control (18 Months)
Description	For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	176	155
Mean (Standard Deviation) [points]	0.4 (1.4)	0.1 (1.5)

13. Secondary Outcome

Title	Angle Magnitude (12 Months)
Description	The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	189	169
Mean (Standard Deviation) [Prism Diopters]	20.0 (9.0)	25.0 (8.0)

14. Secondary Outcome

Title	Angle Magnitude (18 Months)
Description	The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	176	155
Mean (Standard Deviation) [Prism Diopters]	23.0 (9.0)	24.0 (11.0)

15. Secondary Outcome

Title	Stereoacuity at 12 Months
Description	A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	189	169
Mean (Standard Deviation) [arcseconds]	2.0 (0.4)	2.0 (0.4)

16. Secondary Outcome

Title	Stereoacuity at 18 Months
Description	A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	176	155
Mean (Standard Deviation) [arcseconds]	1.9 (0.4)	1.9 (0.4)

17. Secondary Outcome

Title	Compliance With Spectacle Wear (12 Months)
Description	Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	189	169
Excellent (76-100%)	143 73%	128 67.4%
Good (51-75%)	26 13.3%	28 14.7%
Fair (26-50%)	10 5.1%	8 4.2%
Poor (1-25%)	6 3.1%	2 1.1%
Prescribed not wearing (0%)	3 1.5%	2 1.1%
Discontinued	1 0.5%	1 0.5%

18. Secondary Outcome

Title	Compliance With Spectacle Wear (18 Months)
Description	Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	176	155
Excellent (76-100%)	128 65.3%	120 63.2%
Good (51-75%)	23 11.7%	14 7.4%
Fair (26-50%)	8 4.1%	13 6.8%
Poor (1-25%)	9 4.6%	5 2.6%
Prescribed not wearing (0%)	5 2.6%	1 0.5%
Discontinued	3 1.5%	2 1.1%

19. Secondary Outcome

Title	Parent Symptom Survey [12 Months]
Description	A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.
Time Frame	At 12 months

Outcome Measure Data

Analysis Population Description

When number analyzed differs from full population size, it indicates that those children were not wearing spectacles, and therefore could not answer the spectacle related questions.

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	189	169
Missing	1 0.5%	1 0.5%
Never	74 37.8%	71 37.4%
Almost never	58 29.6%	64 33.7%
Sometimes	46 23.5%	32 16.8%
Often	7 3.6%	1 0.5%
Almost Always	3 1.5%	0 0%
Missing	1 0.5%	1 0.5%
Never	75 38.3%	56 29.5%
Almost never	43 21.9%	56 29.5%
Sometimes	60 30.6%	50 26.3%
Often	9 4.6%	6 3.2%
Almost Always	1 0.5%	0 0%
Missing	1 0.5%	1 0.5%
Never	112 57.1%	100 52.6%
Almost never	46 23.5%	43 22.6%
Sometimes	21 10.7%	18 9.5%
Often	7 3.6%	5 2.6%
Almost Always	2 1%	2 1.1%
Missing	1 0.5%	1 0.5%
Never	106 54.1%	105 55.3%
Almost never	41 20.9%	36 18.9%
Sometimes	34 17.3%	26 13.7%
Often	5 2.6%	1 0.5%
Almost Always	2 1%	0 0%
Missing	1 0.5%	1 0.5%
Never	66 33.7%	53 27.9%
Almost never	37 18.9%	40 21.1%
Sometimes	45 23%	52 27.4%
Often	25 12.8%	17 8.9%
Almost Always	11 5.6%	4 2.1%
Missing	1 0.5%	1 0.5%
Never	38 19.4%	32 16.8%
Almost never	45 23%	51 26.8%
Sometimes	63 32.1%	66 34.7%
Often	28 14.3%	16 8.4%
Almost Always	10 5.1%	2 1.1%
Missing	1 0.5%	1 0.5%
Never	112 57.1%	96 50.5%
Almost never	43 21.9%	47 24.7%
Sometimes	18 9.2%	22 11.6%
Often	10 5.1%	2 1.1%
Almost Always	2 1%	0 0%

20. Secondary Outcome

Title	Parent Symptom Survey [18 Months]
Description	A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.
Time Frame	At 18 months

Outcome Measure Data

Analysis Population Description

When number analyzed differs from full population size, it indicates that those children were not wearing spectacles, and therefore could not answer the spectacle related questions.

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere	spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
Measure Participants	176	155
Missing	0 0%	1 0.5%
Never	76 38.8%	63 33.2%
Almost never	49 25%	55 28.9%
Sometimes	46 23.5%	31 16.3%
Often	4 2%	3 1.6%
Almost always	1 0.5%	2 1.1%
Missing	0 0%	1 0.5%
Never	66 33.7%	49 25.8%
Almost never	52 26.5%	50 26.3%
Sometimes	53 27%	49 25.8%
Often	3 1.5%	6 3.2%
Almost always	2 1%	0 0%
Missing	0 0%	1 0.5%
Never	102 52%	94 49.5%
Almost never	44 22.4%	41 21.6%
Sometimes	24 12.2%	14 7.4%
Often	4 2%	4 2.1%
Almost always	2 1%	1 0.5%
Missing	0 0%	1 0.5%
Never	99 50.5%	92 48.4%
Almost never	46 23.5%	37 19.5%
Sometimes	29 14.8%	23 12.1%
Often	1 0.5%	1 0.5%
Almost always	1 0.5%	1 0.5%
Missing	0 0%	1 0.5%
Never	54 27.6%	55 28.9%
Almost never	46 23.5%	33 17.4%
Sometimes	47 24%	48 25.3%
Often	18 9.2%	9 4.7%
Almost always	8 4.1%	5 2.6%
Missing	0 0%	1 0.5%
Never	38 19.4%	32 16.8%
Almost never	36 18.4%	43 22.6%
Sometimes	69 35.2%	55 28.9%
Often	22 11.2%	13 6.8%
Almost always	7 3.6%	8 4.2%
Missing	0 0%	1 0.5%
Never	109 55.6%	96 50.5%
Almost never	41 20.9%	36 18.9%
Sometimes	18 9.2%	14 7.4%
Often	2 1%	4 2.1%
Almost always	4 2%	1 0.5%

Adverse Events

Time Frame	18 months
Adverse Event Reporting Description	Although no adverse events are anticipated as a result of overminus therapy or non-overminus spectacle wear, any new cases of amblyopia, constant esotropia, or constant exotropia at distance and near will be reported. No surgical procedures are part of the protocol and no treatments are being prescribed that are not part of usual care. Investigators will abide by local IRB reporting requirements.
Arm/Group Title	Overminus Treatment		Non-overminus Treatment
Arm/Group Description	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere		spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
All Cause Mortality
	Overminus Treatment		Non-overminus Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/196 (0%)		0/190 (0%)
Serious Adverse Events
	Overminus Treatment		Non-overminus Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/196 (0%)		0/190 (0%)
Other (Not Including Serious) Adverse Events
	Overminus Treatment		Non-overminus Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	47/196 (24%)		15/190 (7.9%)
Eye disorders
Development of Esotropia	4/196 (2%)	4	4/190 (2.1%)	4
>1 Diopter of Myopic Shift	33/196 (16.8%)	33	2/190 (1.1%)	2
2 or more line decrease in visual acuity	12/196 (6.1%)	12	10/190 (5.3%)	10
Amblyopia treatment prescribed by 12 months	2/196 (1%)	2	1/190 (0.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.