IXT3: A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

• Sponsor: Jaeb Center for Health Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT02223650
• Collaborator: Pediatric Eye Disease Investigator Group (Other), National Eye Institute (NEI) (NIH)
• Enrollment: 58
• Locations: 2
• Arms: 2
• Duration (Months): 7
• Patients Per Site: 29
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The objective of this short-term, pilot randomized trial comparing 2.50 diopters (D) overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in children with intermittent exotropia (IXT) 3 to <7 years of age is to determine whether to proceed to a full-scale, longer-term randomized trial.

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

Detailed Description

The objective of this short-term, pilot randomized trial comparing 2.50D overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) is to determine whether to proceed to a full-scale, longer-term randomized trial. This decision will be based primarily on assessing the initial (8-week) response to overminus by comparing treatment groups on the following outcomes:

• Mean distance IXT control score (each patient's score is the mean of 3 control scores) (primary outcome)

• The proportion of subjects with treatment response, defined as 1 or more points improvement in mean of 3 distance IXT control scores (secondary outcome)

• Adverse effects, near visual acuity outcomes, and spectacle wear compliance

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Pilot Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Overminus Treatment 2.50D overminus spectacles	Device: Overminus treatment; 2.50D overminus spectacles; Other Names: Overminus spectacles Overminus glasses Overminus therapy
Active Comparator: Non-overminus Treatment spectacles without overminus or no spectacles	Device: Non-overminus treatment; spectacles without overminus or no spectacles

Outcome Measures

Primary Outcome Measures

1. Mean Distance Exotropia Control Score [8 weeks]

   At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control. *Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.

Secondary Outcome Measures

1. Mean Near Exotropia Control Score [8 weeks]

   At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control.

2. Distribution of Distance Control Score at 8-week Outcome [8 weeks]

   Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.

3. Distribution of Near Control Score at 8-week Outcome [8 weeks]

   Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.

4. Proportion of Subjects With Distance Control Treatment Response [8 weeks]

   A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.

5. Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment? [8 weeks]

   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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

6. Stereoacuity [8 weeks]

   Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.

7. Distance Visual Acuity [8 weeks]

   Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance

8. Binocular Near Visual Acuity [8 weeks]

   Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.

9. Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)? [8 weeks]

   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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

10. Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close? [8 weeks]

    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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

11. Symptom Survey Response to Question: Has Your Child Reported Blurry Vision? [8 weeks]

    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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

12. Proportion of Subjects With Near Control Treatment Response [8 weeks]

    A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

The following criteria must be met for the child to be enrolled in the study:

• Age 3 years to < 7 years

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

• Intermittent exotropia or constant exotropia at distance

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

• Intermittent exotropia, exophoria, or orthophoria at near

• 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)

• No previous non-surgical treatment for IXT (other than refractive correction), including vision therapy for IXT, within the past 6 months.

• No previous substantial overminus treatment, defined as wearing spectacles that are overminused by 1.00D SE or more (treatment with lenses overminused by less than 1.00D SE is allowed at any time prior to enrollment).

• No vision therapy, patching, atropine, or other penalization for amblyopia during the last 2 weeks

• No prior strabismus, intraocular, or refractive surgery (including BOTOX injection)

• Cycloplegic refraction within 7 months, but NOT on the day of enrollment

• Spherical equivalent (SE) in both eyes between -6.00D and +1.00D inclusive

• Distance visual acuity 0.3 logMAR (20/40) or better (by ATS-HOTV) in both eyes

• No interocular difference of distance visual acuity more than 0.2 logMAR (2 lines)

• Child must be wearing refractive correction (pre-study spectacles) for at least 1 week if refractive error (based on cycloplegic refraction performed within 7 months) meets any of the following:

• SE anisometropia ≥1.00 D

• Astigmatism ≥1.00 D in either eye

• SE myopia ≥-0.50 D in either eye

• Refractive correction must meet the following criteria relative to the cycloplegic refraction:

• SE anisometropia must be within <1.0D of the SE anisometropic difference

• Astigmatism must be within <1.00D of full magnitude; axis must be within 10 degrees if ≤1.00D, and within 5 degrees if >1.00D.

• The SE of the spectacles must be within <1.00D of the full cycloplegic refraction SE.

• A correction that yields at least 1.00 D more minus SE than the cycloplegic refraction SE is considered previous substantial overminus lens treatment and the patient is not eligible.

• No current contact lens wear

• No abnormality of the cornea, lens, or central retina

• Gestational age ≥ 32 weeks

• Birth weight > 1500 grams

• No Down syndrome or cerebral palsy

• No 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.

• No disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease

• No current use of any ocular or systemic medication known to affect accommodation or vergence, such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics (e.g., motion sickness patch (scopolamine)), bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)

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

• 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 8 weeks is not anticipated

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marshall B. Ketchum University	Fullerton	California	United States	92831
2	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

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

Investigators

• Study Chair: Jonathan M Holmes, MD, Mayo Clinic
• Study Chair: Angela M Chen, OD, MS, Marshall B. Ketchum University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• PEDIG Public Website

Publications

None provided.

• Responsible Party: Jaeb Center for Health Research
• ClinicalTrials.gov Identifier: NCT02223650
• Other Study ID Numbers: IXT3; 2U10EY011751
• First Posted: Aug 22, 2014
• Last Update Posted: May 19, 2017
• Last Verified: Apr 1, 2017

• 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

Recruitment Details	Between December 2014 and May 2015, 58 children were enrolled at 21 sites, with 31 participants assigned to observation and 27 to overminus treatment.

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Period Title: Overall Study
STARTED	27	31
COMPLETED	27	31
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overminus Treatment	Non-overminus Treatment	Total
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles	Total of all reporting groups
Overall Participants	27	31	58
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.2 (1)	5.1 (1.2)	5.1 (1.1)
Age, Customized (participants) [Number]
3 to <4 years	7 25.9%	3 9.7%	10 17.2%
4 to <5 years	4 14.8%	11 35.5%	15 25.9%
5 to <6 years	9 33.3%	10 32.3%	19 32.8%
6 to <7 years	7 25.9%	7 22.6%	14 24.1%
Sex: Female, Male (Count of Participants)
Female	18 66.7%	18 58.1%	36 62.1%
Male	9 33.3%	13 41.9%	22 37.9%
Race/Ethnicity, Customized (participants) [Number]
White	14 51.9%	15 48.4%	29 50%
Black/African American	2 7.4%	4 12.9%	6 10.3%
Hispanic or Latino	6 22.2%	9 29%	15 25.9%
Asian	5 18.5%	3 9.7%	8 13.8%
Refractive error in more myopic eye (spherical equivalent, D) (participants) [Number]
>+0.50 to +1.00	13 48.1%	15 48.4%	28 48.3%
0 to +0.50	5 18.5%	9 29%	14 24.1%
<0 to >-0.50	2 7.4%	1 3.2%	3 5.2%
-0.50 to >-1.00	4 14.8%	1 3.2%	5 8.6%
-1.00 to >-1.50	1 3.7%	0 0%	1 1.7%
-1.50 to >-2.00	1 3.7%	0 0%	1 1.7%
-2.00 to >-2.50	0 0%	2 6.5%	2 3.4%
-2.50 to >-3.00	0 0%	2 6.5%	2 3.4%
<=-3.00	1 3.7%	1 3.2%	2 3.4%
Accommodative convergence over accommodation (AC/A) ratio (participants) [Number]
<2.5	12 44.4%	13 41.9%	25 43.1%
2.5 to 6.0	12 44.4%	15 48.4%	27 46.6%
>6.0	3 11.1%	3 9.7%	6 10.3%

Outcome Measures

1. Primary Outcome

Title	Mean Distance Exotropia Control Score
Description	At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control. *Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Measure Participants	27	31
Mean (Standard Deviation) [points on control score scale]	2.0 (1.4)	2.8 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overminus Treatment, Non-overminus Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	P-value is calculated for one-sided hypothesis test.
	Method	ANCOVA
	Comments	Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline distance control pre-study spectacle wear, and pre-study IXT treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.75
	Confidence Interval	(2-Sided) 95%; -1.42 to -0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in mean distance control (overminus - observation) and 95% CI from ANCOVA model adjusting for baseline control, pre-study spectacle wear, and pre-study treatment for IXT. + difference suggests observation group worse than overminus group

2. Secondary Outcome

Title	Mean Near Exotropia Control Score
Description	At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Measure Participants	27	31
Mean (Standard Deviation) [points on control score scale]	0.9 (1.2)	1.2 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overminus Treatment, Non-overminus Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments	P-value is calculated for one-sided hypothesis test.
	Method	ANCOVA
	Comments	Comparison of mean 8-wk near control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95%; -0.68 to 0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.

3. Secondary Outcome

Title	Distribution of Distance Control Score at 8-week Outcome
Description	Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Measure Participants	27	31
0 to <1	4 14.8%	1 3.2%
1 to <2	11 40.7%	7 22.6%
2 to <3	5 18.5%	10 32.3%
3 to <4	1 3.7%	3 9.7%
4 to 5	6 22.2%	10 32.3%

4. Secondary Outcome

Title	Distribution of Near Control Score at 8-week Outcome
Description	Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Measure Participants	27	31
0 to <1	15 55.6%	10 32.3%
1 to <2	7 25.9%	13 41.9%
2 to <3	2 7.4%	3 9.7%
3 to <4	2 7.4%	5 16.1%
4 to 5	1 3.7%	0 0%

5. Secondary Outcome

Title	Proportion of Subjects With Distance Control Treatment Response
Description	A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Measure Participants	27	31
Number [participants]	16 59.3%	12 38.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overminus Treatment, Non-overminus Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments	The p-value was not adjusted for multiple comparisons.
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	21
	Confidence Interval	(2-Sided) 95%; -6 to 45
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	Spectacle-related questions at follow up apply to all overminus group participants.	Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.
Measure Participants	27	10
Looked over specatcles: Always	0 0%	0 0%
Looked over specatcles: Often	3 11.1%	1 3.2%
Looked over specatcles: Sometimes	7 25.9%	2 6.5%
Looked over specatcles: Rarely	2 7.4%	2 6.5%
Looked over specatcles: Never	15 55.6%	5 16.1%

7. Secondary Outcome

Title	Stereoacuity
Description	Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Measure Participants	27	31
Mean (Standard Deviation) [log arcsecond]	2.2 (0.5)	2.2 (0.6)

8. Secondary Outcome

Title	Distance Visual Acuity
Description	Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Measure Participants	27	31
Mean (Standard Deviation) [prism diopters]	21.1 (11.2)	23.0 (6.3)

9. Secondary Outcome

Title	Binocular Near Visual Acuity
Description	Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Measure Participants	27	31
Mean (Standard Deviation) [prism diopters]	12.8 (8.3)	16.9 (8.4)

10. Secondary Outcome

Title	Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	Spectacle-related questions at follow up apply to all overminus group participants.	Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.
Measure Participants	27	31
Always	0 0%	0 0%
Often	0 0%	0 0%
Sometimes	4 14.8%	3 9.7%
Rarely	5 18.5%	4 12.9%
Never	18 66.7%	24 77.4%

11. Secondary Outcome

Title	Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Measure Participants	27	31
Always	0 0%	0 0%
Often	0 0%	0 0%
Sometimes	1 3.7%	1 3.2%
Rarely	0 0%	2 6.5%
Never	26 96.3%	28 90.3%

12. Secondary Outcome

Title	Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Measure Participants	27	31
Always	0 0%	0 0%
Often	0 0%	0 0%
Sometimes	1 3.7%	1 3.2%
Rarely	1 3.7%	1 3.2%
Never	25 92.6%	29 93.5%

13. Secondary Outcome

Title	Proportion of Subjects With Near Control Treatment Response
Description	A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overminus Treatment	Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles	spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
Measure Participants	27	31
Number [participants]	7 25.9%	8 25.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overminus Treatment, Non-overminus Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments	The p-value was not adjusted for multiple comparisons.
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.001
	Confidence Interval	(2-Sided) 95%; -23 to 24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Baseline to 8 weeks after randomization.
Arm/Group Title	Overminus Treatment		Non-overminus Treatment
Arm/Group Description	2.50D overminus spectacles Overminus treatment: 2.50D overminus spectacles		spectacles without overminus or no spectacles Non-overminus treatment: spectacles without overminus or no spectacles
All Cause Mortality
	Overminus Treatment		Non-overminus Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Overminus Treatment		Non-overminus Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Overminus Treatment		Non-overminus Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/27 (11.1%)		2/31 (6.5%)
Eye disorders
Development of esodeviation	1/27 (3.7%)	1	0/31 (0%)	0
Reduction in monocular distance visual acuity >=2 lines	2/27 (7.4%)	2	1/31 (3.2%)	1
Reduction in binocular near visual acuity >=2 lines	0/27 (0%)	0	1/31 (3.2%)	1

Limitations/Caveats

Small sample size; only 8-weeks of follow up; high test-retest variability of control; some regression to the mean may be present; do not know if treatment effect would persist after overminus lenses are replaced with usual spectacle correction.

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.