Infant Aphakia Treatment Study (IATS)

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00212134
• Collaborator: National Eye Institute (NEI) (NIH), Alcon Research (Industry), Bausch & Lomb Incorporated (Industry), BSN-JOBST Inc. (Industry), Eye Care and Cure (Industry)
• Enrollment: 114
• Locations: 13
• Arms: 2
• Actual Duration (Months): 189
• Patients Per Site: 8.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The primary purpose is to determine whether infants with a unilateral congenital cataract are more likely to develop better vision following cataract extraction surgery if they undergo primary implantation of an intraocular lens or if they are treated primarily with a contact lens. In addition, the study will compare the occurrence of postoperative complications and the degree of parental stress between the two treatments.

Condition or Disease	Intervention/Treatment	Phase
Congenital Cataract	Device: Contact lens correction of aphakia; Device: Intraocular lens implantation	N/A

Detailed Description

Intraocular lenses are now a commonly accepted treatment for cataracts in older children and are used increasingly in younger children and infants. Intraocular lenses are superior to contact lenses in that they more closely replicate the optics of the crystalline lens, do not require daily ongoing care, and ensure at least a partial optical correction at all times. The simplicity and improved visual outcome of an intraocular lens correction may make caring for a child with a unilateral congenital cataract less stressful for parents. However, contact lenses remain the accepted treatment for children under 1 year of age due to concerns about the long-term safety of intraocular lenses and the potential for a large myopic shift developing in these eyes as they grow. Contact lenses provide excellent visual results in infants treated for bilateral congenital cataracts; however, two-thirds of infants treated with contact lenses for unilateral congenital cataracts remain legally blind in their aphakic eye. These poor visual outcomes are usually ascribed to competition from the sound eye and poor compliance with patching and contact lens wear regimens. Data from our pilot study and the literature suggest that superior visual results can be obtained if an intraocular lens is used to correct unilateral aphakia during infancy, but these eyes will experience more complications. Intraocular lenses will be increasingly implanted in infants regardless of whether or not we perform this trial. By performing this clinical trial, we can determine if the higher rate of complications with intraocular lenses is offset by improved visual outcome and decreased parenting stress.

The Infant Aphakia Treatment Study (IATS) is a multi-center randomized clinical trial comparing intraocular lens and contact lens correction for monocular aphakia. Infants will be enrolled over a 4 year period. Infants 28 to 210 days of age with a visually significant cataract in one eye are eligible. Cataract surgery will be performed in a standardized fashion by a surgeon who has been certified for the study. Surgery consists of a lensectomy, posterior capsulotomy, and anterior vitrectomy. Infants will be randomized at the time of surgery to one of two treatment groups. Infants randomized to the intraocular lens group will have an intraocular lens implanted into the capsular bag. Spectacles will subsequently be used to correct the residual refractive errors. Infants randomized to the contact lens group will be fitted with a contact lens immediately after surgery. Both groups will receive the same patching therapy and follow-up. All children will be examined by Investigators at fixed intervals using standard protocols with the major endpoint assessed at age 12 months by a Traveling Vision Examiner.

We are currently in a continuation of this project (beyond 5 years) in order to assess which of these patients have glaucoma or glaucoma suspect at age 10.5 years. Our goal is to understand which type of initial optical correction, an IOL or a CL, results in the best long-term visual outcome following unilateral congenital cataract surgery during infancy. Our central hypothesis is that primary IOL implantation will result in a better visual outcome. The rationale for this proposal is that final visual acuity cannot be determined by 5 years of age and the recommendation for early treatment can only be substantiated by adequate long-term assessment in this unique cohort. We chose a follow-up to age 10.5 years because it will provide a more accurate assessment of visual acuity and will allow us to diagnosis most cases of glaucoma.

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Phase 3 is 10.5-year follow-up study since Phase 1. There is no intervention.Phase 3 is 10.5-year follow-up study since Phase 1. There is no intervention.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Infant Aphakia Treatment Study (IATS)
• Actual Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: aphakic contact lens Contact lens correction of aphakia INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly.	Device: Contact lens correction of aphakia; optical correction of infant surgical aphakia with Contact lens; Other Names: Silsoft aphakic contact lens rigid gas permeable contact lens
Experimental: aphakic intraocular lens Intraocular lens implantation INTERVENTION: At the time of surgery to remove the cataractous natural lens, an intraocular lens was implanted to correct the large hyperopic refractive error induced by the cataract surgery.	Device: Intraocular lens implantation; optical correction of surgical aphakia with intraocular lens; Other Names: Alcon SA60AT Alcon MA60AC

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [Phase 1 - Age 12 months]

   Visual acuity was measured by standard objective testing procedures at 12 months of age. Monocular grating acuity was assessed by the traveling examiner with the Teller Acuity Cards. This test uses cards with black-on-white lines of varying widths and a set distance apart in a square with fixed dimensions, so the thinner the lines, the more there will be on any given card (cycles/cm). The ability to see thinner lines indicates better vision. The cards with lines are presented simultaneously with a gray card and the child's visual attention is noted. It is presumed that the child will preferentially look at the card with the stripes as it is more interesting. When the lines are too thin and close together so as to be indistinguishable from the gray card, no preferential looking will be noted. The card with the thinnest lines that the child will look at is recorded as the best visual acuity in logMAR units.

2. Visual Acuity - Subjective Assessment at Age 4.5 Years. [Phase 2 - Age 4.5 Years]

   Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 4.5 years of age allowing the use of the HOTV recognition acuity test. The Amblyopia Treatment Study protocol for presentation and determination of best corrected visual acuity was followed. Monocular visual acuity was evaluated using single letter optotypes with surround bars presented on the EVAT. The staircase procedure of the ATS projects was followed as this has documented success and reliability with this age group. In order to familiarize the subjects with the HOTV matching test, this test was introduced at the 4.0 year visit and the 4.25 year visit by experienced site personnel.

3. Visual Acuity - Subjective Assessment at Age 10 Years. [Phase 3 - Age 10.5 Years]

   Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 10.5 years of age allowing the use of the electronic early treatment diabetic retinopathy study (E-ETDRS) testing protocol. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision).

Secondary Outcome Measures

1. Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery [Cataract surgery immediately after enrollment]

   Percent of Patients with 1 or More Intraoperative Complications at Cataract Surgery

2. Percent of Patients With 1 or More Adverse Events [Study enrollment to age 5 years]

3. Parenting Stress [Phase 1 - 3 months post surgery]

   The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252.

4. Adherence to Occlusion Therapy [Phase 1 - 12 months follow-up]

   Parental report of the number of hours children wore an patch to occlude the fellow eye.

5. Parenting Stress [Phase 1 - Age 12 Months]

   The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Days to 210 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Visually significant unilateral congenital cataract (central opacity equal to or greater than 3 mm in size).

• Cataract surgery performed when the patient is 28 to 210 days of age and at least 41 post-conceptional weeks.

Exclusion Criteria:

• The cataract is known to be acquired from trauma or as a side-effect of a treatment administered postnatally such as radiation or medical therapy.

• A corneal diameter less than 9 mm measured in the horizontal meridian using calipers.

• An intraocular pressure of 25 mm Hg or greater in the affected eye measured with a Perkins tonometer, tonopen, or pneumatonometer.

• Persistent fetal vasculature (PFV) causing stretching of the ciliary processes or a tractional retinal detachment.

• Active uveitis or signs suggestive of a previous episode of uveitis such as posterior synechiae or keratic precipitates.

• The child is the product of a pre-term pregnancy (<36 gestational weeks). Screening for prematurity will be based on the clinician's best assessment of gestational age. If a physician is uncertain regarding the gestational age, review of medical records or contact with the pediatrician and/or obstetrician should be used to confirm gestational age at delivery. Unless a clinician is uncertain as to whether a child was born at less than 36 weeks or not, confirmation of gestational age via medical record review may be delayed until after enrollment.

• Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity.

• Previous intraocular surgery.

• Optic nerve disease that may limit the visual potential of the eye such as optic nerve hypoplasia.

• The fellow eye has ocular disease that might reduce its visual potential.

• The child has a medical condition known to limit the ability to obtain visual acuity at 12 months or 4 years of age.

• Refusal by the Parent/Legal Guardian to sign an informed consent or to be randomized to one of the two treatment groups.

• Follow-up of the child is not feasible because the child would not be able to return for regular follow-up examinations and the outcome assessments (e.g. transportation difficulties, relocation, etc.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94303
2	Miami Children's Hospital	Miami	Florida	United States	33155
3	Emory Eye Center	Atlanta	Georgia	United States	30322
4	Indiana University Medical Center	Indianapolis	Indiana	United States	46202-5175
5	Harvard University	Boston	Massachusetts	United States	02115
6	University of Minnesota	Minneapolis	Minnesota	United States	55455-0501
7	Duke University Eye Center	Durham	North Carolina	United States	27710
8	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
9	Oregon Health and Science University	Portland	Oregon	United States	97239-4197
10	Medical University of South Carolina	Charleston	South Carolina	United States	29425-2236
11	Vanderbilt University	Nashville	Tennessee	United States	37232-8808
12	Pediatric Ophthalmology, P.A.	Dallas	Texas	United States	75225
13	Baylor University	Houston	Texas	United States	77030

Sponsors and Collaborators

• Stanford University
• National Eye Institute (NEI)
• Alcon Research
• Bausch & Lomb Incorporated
• BSN-JOBST Inc.
• Eye Care and Cure

Investigators

• Study Chair: Scott Lambert, MD, Stanford University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 29, 2015
• Informed Consent Form - Sep 25, 2015

More Information

Additional Information:

• NEI Clinical Studies Database--Infant Aphakia Treatment Study (IATS)

Publications

None provided.

• Responsible Party: Scott Reed Lambert, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT00212134
• Other Study ID Numbers: IRB00024837; U10EY013272; EY013287; EY013272; NEI-108
• First Posted: Sep 21, 2005
• Last Update Posted: Jul 7, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Scott Reed Lambert, Professor, Stanford University: cataract surgery; intraocular lens; contact lens; infants; aphakia
• Additional relevant MeSH terms: Cataract; Aphakia; Dipivefrin

Study Results

Participant Flow

Recruitment Details	Recruitment 12/23/04 to 01/16/09 at 12 medical clinics.
Pre-assignment Detail	Final eligibility determined at pre-operative ocular examination under anesthesia.

Arm/Group Title	Aphakic Contact Lens	Aphakic Intraocular Lens
Arm/Group Description	optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens	optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens
Period Title: Phase 1 (to Age 1 Year)
STARTED	57	57
Complete First Endpoint at 1 Year	57	57
COMPLETED	57	57
NOT COMPLETED	0	0
Period Title: Phase 1 (to Age 1 Year)
STARTED	57	57
COMPLETED	57	56
NOT COMPLETED	0	1
Period Title: Phase 1 (to Age 1 Year)
STARTED	57	56
COMPLETED	55	55
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Aphakic Contact Lens	Aphakic Intraocular Lens	Total
Arm/Group Description	optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens	optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens	Total of all reporting groups
Overall Participants	57	57	114
Age (months) [Mean (Standard Deviation) ]
mean/sd	2.4 (1.6)	2.5 (1.6)	2.5 (1.6)
Age, Customized (participants) [Number]
28 - 48 days	25 43.9%	25 43.9%	50 43.9%
49 days - 3.0 months	17 29.8%	15 26.3%	32 28.1%
3.1 - 5.0 months	9 15.8%	10 17.5%	19 16.7%
5.1 - 6.8 months	6 10.5%	7 12.3%	13 11.4%
Sex: Female, Male (Count of Participants)
Female	32 56.1%	28 49.1%	60 52.6%
Male	25 43.9%	29 50.9%	54 47.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 15.8%	10 17.5%	19 16.7%
Not Hispanic or Latino	48 84.2%	47 82.5%	95 83.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.8%	0 0%	1 0.9%
Asian	2 3.5%	1 1.8%	3 2.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 5.3%	5 8.8%	8 7%
White	49 86%	48 84.2%	97 85.1%
More than one race	0 0%	3 5.3%	3 2.6%
Unknown or Not Reported	2 3.5%	0 0%	2 1.8%
Region of Enrollment (participants) [Number]
United States	57 100%	57 100%	114 100%
Private Insurance (participants) [Number]
No	20 35.1%	24 42.1%	44 38.6%
Yes	37 64.9%	33 57.9%	70 61.4%
Qualified for Medicaid (participants) [Number]
No	40 70.2%	35 61.4%	75 65.8%
Yes	17 29.8%	22 38.6%	39 34.2%
Pupil Diameter - Cataractous Eye (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	3.3 (1.0)	3.2 (1.0)	3.3 (1.0)
Pupil Diameter - Fellow Eye (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	3.5 (0.9)	3.4 (0.9)	3.4 (0.9)
Corneal Diameter - Cataractous Eye (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	10.5 (0.7)	10.5 (0.8)	10.5 (0.7)
Corneal Diameter - Fellow Eye (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	10.8 (0.6)	10.8 (0.7)	10.8 (0.6)
Intraocular Pressure - Cataractous Eye (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	12.7 (4.9)	11.8 (4.9)	12.2 (4.9)
Intraocular Pressure - Fellow Eye (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	12.8 (5.1)	12.9 (4.3)	12.9 (4.7)
Keratometric Power - Cataractous Eye (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	46.4 (2.7)	46.4 (2.7)	46.4 (2.7)
Keratometric Power - Fellow Eye (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	45.5 (1.8)	45.4 (1.9)	45.5 (1.8)
Axial Length - Cataractous Eye (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	18.0 (1.3)	18.1 (1.3)	18.0 (1.3)
Axial Length - Fellow Eye (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	18.4 (0.9)	18.7 (0.9)	18.6 (0.9)
Refractive Error - Fellow Eye (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	2.4 (1.8)	2.3 (2.2)	2.3 (2.0)

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	Visual acuity was measured by standard objective testing procedures at 12 months of age. Monocular grating acuity was assessed by the traveling examiner with the Teller Acuity Cards. This test uses cards with black-on-white lines of varying widths and a set distance apart in a square with fixed dimensions, so the thinner the lines, the more there will be on any given card (cycles/cm). The ability to see thinner lines indicates better vision. The cards with lines are presented simultaneously with a gray card and the child's visual attention is noted. It is presumed that the child will preferentially look at the card with the stripes as it is more interesting. When the lines are too thin and close together so as to be indistinguishable from the gray card, no preferential looking will be noted. The card with the thinnest lines that the child will look at is recorded as the best visual acuity in logMAR units.
Time Frame	Phase 1 - Age 12 months

Outcome Measure Data

Analysis Population Description

The number of participants was determined by the sample size estimate necessary to detect a 0.2 logMAR difference (2 lines on the Snellen chart) in the visual acuity between the two groups.

Arm/Group Title	Aphakic Contact Lens	Aphakic Intraocular Lens
Arm/Group Description	optical correction of infant aphakia with aphakic Contact lens INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly.	optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: The refractive error induced by surgical removal of the cataractous natural lens is partially corrected by the implantation of an intraocular lens (IOL) at the time of surgery. This is deemed a permanent correction as the IOL may only be removed in a subsequent surgery.
Measure Participants	57	57
Median (Inter-Quartile Range) [logMAR units]	0.80	0.97

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aphakic Contact Lens, Aphakic Intraocular Lens
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Visual Acuity - Subjective Assessment at Age 4.5 Years.
Description	Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 4.5 years of age allowing the use of the HOTV recognition acuity test. The Amblyopia Treatment Study protocol for presentation and determination of best corrected visual acuity was followed. Monocular visual acuity was evaluated using single letter optotypes with surround bars presented on the EVAT. The staircase procedure of the ATS projects was followed as this has documented success and reliability with this age group. In order to familiarize the subjects with the HOTV matching test, this test was introduced at the 4.0 year visit and the 4.25 year visit by experienced site personnel.
Time Frame	Phase 2 - Age 4.5 Years

Outcome Measure Data

Analysis Population Description

One patient in the intraocular lens group was lost to follow-up.at age 18 months. A second patient in that group had developmental delay and the visual acuity could not be assessed. Therefore, the visual acuity measurements at 4.5 years of age are reported for 55 of the 57 patients randomized to the intraocular lens group.

Arm/Group Title	Aphakic Contact Lens	Aphakic Intraocular Lens
Arm/Group Description	optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens	optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens
Measure Participants	57	55
Median (Inter-Quartile Range) [logMAR units]	0.90	0.90

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aphakic Contact Lens, Aphakic Intraocular Lens
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Primary Outcome

Title	Visual Acuity - Subjective Assessment at Age 10 Years.
Description	Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 10.5 years of age allowing the use of the electronic early treatment diabetic retinopathy study (E-ETDRS) testing protocol. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision).
Time Frame	Phase 3 - Age 10.5 Years

Outcome Measure Data

Analysis Population Description

Participants who completed the third phase of the study are included in the analysis.

Arm/Group Title	Aphakic Contact Lens	Aphakic Intraocular Lens
Arm/Group Description	optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens	optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens
Measure Participants	55	55
Median (Inter-Quartile Range) [logMAR units]	0.86	0.89

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aphakic Contact Lens, Aphakic Intraocular Lens
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.82
	Comments
	Method	Chi-squared
	Comments

4. Secondary Outcome

Title	Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery
Description	Percent of Patients with 1 or More Intraoperative Complications at Cataract Surgery
Time Frame	Cataract surgery immediately after enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aphakic Contact Lens	Aphakic Intraocular Lens
Arm/Group Description	optical correction of infant aphakia with aphakic Contact lens INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly. hyperopic correction of infant surgical aphakia with Contact Lens: optical correction of infant surgical aphakia with Contact lens	optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: At the time of surgery to remove the cataractous natural lens, an intraocular lens was implanted to correct the large hyperopic refractive error induced by the cataract surgery. primary implantation of aphakic intraocular lens: optical correction of surgical aphakia with intraocular lens
Measure Participants	57	57
Number (95% Confidence Interval) [percentage of patients]	11	28

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aphakic Contact Lens, Aphakic Intraocular Lens
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	Percent of Patients With 1 or More Adverse Events
Time Frame	Study enrollment to age 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aphakic Contact Lens	Aphakic Intraocular Lens
Arm/Group Description	optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens	optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens
Measure Participants	57	57
Number (95% Confidence Interval) [percentage of patients]	56	81

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aphakic Contact Lens, Aphakic Intraocular Lens
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Fisher Exact
	Comments

6. Secondary Outcome

Title	Parenting Stress
Description	The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252.
Time Frame	Phase 1 - 3 months post surgery

Outcome Measure Data

Analysis Population Description

All those who completed the PSI 3 months after surgery.

Arm/Group Title	Aphakic Contact Lens	Aphakic Intraocular Lens
Arm/Group Description	optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens	optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens
Measure Participants	55	53
Mean (Standard Deviation) [units on a scale]	197.4 (35.7)	231.1 (36.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aphakic Contact Lens, Aphakic Intraocular Lens
	Comments	ITT analyses comparing parents of children randomized to receive an IOL to those left aphakic.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	15.7
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Adherence to Occlusion Therapy
Description	Parental report of the number of hours children wore an patch to occlude the fellow eye.
Time Frame	Phase 1 - 12 months follow-up

Outcome Measure Data

Analysis Population Description

Analysis is limited to those with at least 3 reports of adherence before 12 months of age.

Arm/Group Title	Aphakic Contact Lens	Aphakic Intraocular Lens
Arm/Group Description	optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens	optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens
Measure Participants	53	53
Mean (Standard Deviation) [Hours patched per day]	3.92 (1.55)	3.63 (1.68)

8. Secondary Outcome

Title	Parenting Stress
Description	The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252
Time Frame	Phase 1 - Age 12 Months

Outcome Measure Data

Analysis Population Description

All those who completed the PSI 3 months after surgery and the PSI at age 12 months

Arm/Group Title	Aphakic Contact Lens	Aphakic Intraocular Lens
Arm/Group Description	optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens	optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens
Measure Participants	43	38
Mean (Standard Deviation) [units on a scale]	202.6 (34.4)	208.3 (30.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aphakic Contact Lens, Aphakic Intraocular Lens
	Comments	ITT comparison of mean PSI scores
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.295
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Arm/Group Title	Aphakic Contact Lens		Aphakic Intraocular Lens
Arm/Group Description	optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens		optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens
All Cause Mortality
	Aphakic Contact Lens		Aphakic Intraocular Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/57 (0%)
Serious Adverse Events
	Aphakic Contact Lens		Aphakic Intraocular Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Aphakic Contact Lens		Aphakic Intraocular Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/57 (56.1%)		46/57 (80.7%)
Eye disorders
Lens reproliferation into visual axis	2/57 (3.5%)	2	23/57 (40.4%)	23
Pupillary membrane	2/57 (3.5%)	2	16/57 (28.1%)	16
Corectopia	1/57 (1.8%)	1	16/57 (28.1%)	16
Glaucoma	9/57 (15.8%)	9	11/57 (19.3%)	11
Glaucoma suspect	11/57 (19.3%)	11	5/57 (8.8%)	5
Contact lens related adverse event	10/57 (17.5%)	10	0/57 (0%)	0
Vitreous hemorrhage	2/57 (3.5%)	2	5/57 (8.8%)	5
Retinal hemorrhage	2/57 (3.5%)	2	3/57 (5.3%)	3
Hyphema	1/57 (1.8%)	1	4/57 (7%)	4
Retained cortex	2/57 (3.5%)	2	3/57 (5.3%)	3
Retinal detachment	2/57 (3.5%)	2	0/57 (0%)	0
Endophthalmitis	1/57 (1.8%)	1	0/57 (0%)	0
Phthisis bulbi	1/57 (1.8%)	1	0/57 (0%)	0
Corneal edema lasting more than 30 days	0/57 (0%)	0	1/57 (1.8%)	1
Wound leak or dehisence	0/57 (0%)	0	1/57 (1.8%)	1
Intraocular lens capture	0/57 (0%)	0	1/57 (1.8%)	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.