Trial Outcomes & Findings for Infant Aphakia Treatment Study (IATS) (NCT NCT00212134)

Last Updated: 2024-07-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

114 participants

Primary outcome timeframe

Phase 1 - Age 12 months

Results posted on

2024-07-24

Participant Flow

Recruitment 12/23/04 to 01/16/09 at 12 medical clinics.

Final eligibility determined at pre-operative ocular examination under anesthesia.

Participant milestones

Participant milestones
Measure	Aphakic Contact Lens optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens	Aphakic Intraocular Lens optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens
Phase 1 (to Age 1 Year) STARTED	57	57
Phase 1 (to Age 1 Year) Complete First Endpoint at 1 Year	57	57
Phase 1 (to Age 1 Year) COMPLETED	57	57
Phase 1 (to Age 1 Year) NOT COMPLETED	0	0
Phase 2 (Age 1 Year to Age 5 Years) STARTED	57	57
Phase 2 (Age 1 Year to Age 5 Years) COMPLETED	57	56
Phase 2 (Age 1 Year to Age 5 Years) NOT COMPLETED	0	1
Phase 3 (Age 10 Years) STARTED	57	56
Phase 3 (Age 10 Years) COMPLETED	55	55
Phase 3 (Age 10 Years) NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Infant Aphakia Treatment Study (IATS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aphakic Contact Lens n=57 Participants optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens	Aphakic Intraocular Lens n=57 Participants optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens	Total n=114 Participants Total of all reporting groups
Age, Continuous mean/sd	2.4 months STANDARD_DEVIATION 1.6 • n=5 Participants	2.5 months STANDARD_DEVIATION 1.6 • n=7 Participants	2.5 months STANDARD_DEVIATION 1.6 • n=5 Participants
Age, Customized 28 - 48 days	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Age, Customized 49 days - 3.0 months	17 participants n=5 Participants	15 participants n=7 Participants	32 participants n=5 Participants
Age, Customized 3.1 - 5.0 months	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants
Age, Customized 5.1 - 6.8 months	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	57 participants n=7 Participants	114 participants n=5 Participants
Private Insurance No	20 participants n=5 Participants	24 participants n=7 Participants	44 participants n=5 Participants
Private Insurance Yes	37 participants n=5 Participants	33 participants n=7 Participants	70 participants n=5 Participants
Qualified for Medicaid No	40 participants n=5 Participants	35 participants n=7 Participants	75 participants n=5 Participants
Qualified for Medicaid Yes	17 participants n=5 Participants	22 participants n=7 Participants	39 participants n=5 Participants
Pupil Diameter - Cataractous Eye	3.3 mm STANDARD_DEVIATION 1.0 • n=5 Participants	3.2 mm STANDARD_DEVIATION 1.0 • n=7 Participants	3.3 mm STANDARD_DEVIATION 1.0 • n=5 Participants
Pupil Diameter - Fellow Eye	3.5 mm STANDARD_DEVIATION 0.9 • n=5 Participants	3.4 mm STANDARD_DEVIATION 0.9 • n=7 Participants	3.4 mm STANDARD_DEVIATION 0.9 • n=5 Participants
Corneal Diameter - Cataractous Eye	10.5 mm STANDARD_DEVIATION 0.7 • n=5 Participants	10.5 mm STANDARD_DEVIATION 0.8 • n=7 Participants	10.5 mm STANDARD_DEVIATION 0.7 • n=5 Participants
Corneal Diameter - Fellow Eye	10.8 mm STANDARD_DEVIATION 0.6 • n=5 Participants	10.8 mm STANDARD_DEVIATION 0.7 • n=7 Participants	10.8 mm STANDARD_DEVIATION 0.6 • n=5 Participants
Intraocular Pressure - Cataractous Eye	12.7 mmHg STANDARD_DEVIATION 4.9 • n=5 Participants	11.8 mmHg STANDARD_DEVIATION 4.9 • n=7 Participants	12.2 mmHg STANDARD_DEVIATION 4.9 • n=5 Participants
Intraocular Pressure - Fellow Eye	12.8 mmHg STANDARD_DEVIATION 5.1 • n=5 Participants	12.9 mmHg STANDARD_DEVIATION 4.3 • n=7 Participants	12.9 mmHg STANDARD_DEVIATION 4.7 • n=5 Participants
Keratometric Power - Cataractous Eye	46.4 diopters STANDARD_DEVIATION 2.7 • n=5 Participants	46.4 diopters STANDARD_DEVIATION 2.7 • n=7 Participants	46.4 diopters STANDARD_DEVIATION 2.7 • n=5 Participants
Keratometric Power - Fellow Eye	45.5 diopters STANDARD_DEVIATION 1.8 • n=5 Participants	45.4 diopters STANDARD_DEVIATION 1.9 • n=7 Participants	45.5 diopters STANDARD_DEVIATION 1.8 • n=5 Participants
Axial Length - Cataractous Eye	18.0 mm STANDARD_DEVIATION 1.3 • n=5 Participants	18.1 mm STANDARD_DEVIATION 1.3 • n=7 Participants	18.0 mm STANDARD_DEVIATION 1.3 • n=5 Participants
Axial Length - Fellow Eye	18.4 mm STANDARD_DEVIATION 0.9 • n=5 Participants	18.7 mm STANDARD_DEVIATION 0.9 • n=7 Participants	18.6 mm STANDARD_DEVIATION 0.9 • n=5 Participants
Refractive Error - Fellow Eye	2.4 diopters STANDARD_DEVIATION 1.8 • n=5 Participants	2.3 diopters STANDARD_DEVIATION 2.2 • n=7 Participants	2.3 diopters STANDARD_DEVIATION 2.0 • n=5 Participants

PRIMARY outcome

Timeframe: Phase 1 - Age 12 months

Population: 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.

Outcome measures

Outcome measures
Measure	Aphakic Contact Lens n=57 Participants 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.	Aphakic Intraocular Lens n=57 Participants 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.
Visual Acuity	0.80 logMAR units Interval 0.66 to 0.97	0.97 logMAR units Interval 0.8 to 1.1

PRIMARY outcome

Timeframe: Phase 2 - Age 4.5 Years

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Aphakic Contact Lens n=57 Participants 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.	Aphakic Intraocular Lens n=55 Participants 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.
Visual Acuity - Subjective Assessment at Age 4.5 Years.	0.90 logMAR units Interval 0.3 to 1.6	0.90 logMAR units Interval 0.4 to 1.73

PRIMARY outcome

Timeframe: Phase 3 - Age 10.5 Years

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

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).

Outcome measures

Outcome measures
Measure	Aphakic Contact Lens n=55 Participants 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.	Aphakic Intraocular Lens n=55 Participants 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.
Visual Acuity - Subjective Assessment at Age 10 Years.	0.86 logMAR units Interval 0.3 to 1.46	0.89 logMAR units Interval 0.33 to 1.43

SECONDARY outcome

Timeframe: Cataract surgery immediately after enrollment

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

Outcome measures

Outcome measures
Measure	Aphakic Contact Lens n=57 Participants 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.	Aphakic Intraocular Lens n=57 Participants 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.
Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery	11 percentage of patients Interval 4.0 to 22.0	28 percentage of patients Interval 17.0 to 42.0

SECONDARY outcome

Timeframe: Study enrollment to age 5 years

Outcome measures

Outcome measures
Measure	Aphakic Contact Lens n=57 Participants 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.	Aphakic Intraocular Lens n=57 Participants 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.
Percent of Patients With 1 or More Adverse Events	56 percentage of patients Interval 42.0 to 69.0	81 percentage of patients Interval 68.0 to 90.0

SECONDARY outcome

Timeframe: Phase 1 - 3 months post surgery

Population: All those who completed the PSI 3 months after 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.

Outcome measures

Outcome measures
Measure	Aphakic Contact Lens n=55 Participants 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.	Aphakic Intraocular Lens n=53 Participants 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.
Parenting Stress	197.4 units on a scale Standard Deviation 35.7	231.1 units on a scale Standard Deviation 36.8

SECONDARY outcome

Timeframe: Phase 1 - 12 months follow-up

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

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

Outcome measures

Outcome measures
Measure	Aphakic Contact Lens n=53 Participants 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.	Aphakic Intraocular Lens n=53 Participants 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.
Adherence to Occlusion Therapy	3.92 Hours patched per day Standard Deviation 1.55	3.63 Hours patched per day Standard Deviation 1.68

SECONDARY outcome

Timeframe: Phase 1 - Age 12 Months

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

Outcome measures

Outcome measures
Measure	Aphakic Contact Lens n=43 Participants 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.	Aphakic Intraocular Lens n=38 Participants 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.
Parenting Stress	202.6 units on a scale Standard Deviation 34.4	208.3 units on a scale Standard Deviation 30.8

Adverse Events

Aphakic Contact Lens

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Aphakic Intraocular Lens

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Scott R Lambert, MD, Study Chairman

Stanford University School of Medicine

Phone: 650-498-4242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Aphakic Contact Lens n=57 participants at risk optical correction of infant aphakia with aphakic Contact lens INTERVENTION: aphakic contact lens	Aphakic Intraocular Lens n=57 participants at risk optical correction of infant aphakia with aphakic Intraocular Lens INTERVENTION: aphakic intraocular lens
Eye disorders Lens reproliferation into visual axis	3.5% 2/57 • Number of events 2 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	40.4% 23/57 • Number of events 23 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Pupillary membrane	3.5% 2/57 • Number of events 2 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	28.1% 16/57 • Number of events 16 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Corectopia	1.8% 1/57 • Number of events 1 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	28.1% 16/57 • Number of events 16 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Glaucoma	15.8% 9/57 • Number of events 9 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	19.3% 11/57 • Number of events 11 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Glaucoma suspect	19.3% 11/57 • Number of events 11 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	8.8% 5/57 • Number of events 5 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Contact lens related adverse event	17.5% 10/57 • Number of events 10 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	0.00% 0/57 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Vitreous hemorrhage	3.5% 2/57 • Number of events 2 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	8.8% 5/57 • Number of events 5 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Retinal hemorrhage	3.5% 2/57 • Number of events 2 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	5.3% 3/57 • Number of events 3 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Hyphema	1.8% 1/57 • Number of events 1 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	7.0% 4/57 • Number of events 4 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Retained cortex	3.5% 2/57 • Number of events 2 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	5.3% 3/57 • Number of events 3 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Retinal detachment	3.5% 2/57 • Number of events 2 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	0.00% 0/57 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Endophthalmitis	1.8% 1/57 • Number of events 1 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	0.00% 0/57 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Phthisis bulbi	1.8% 1/57 • Number of events 1 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	0.00% 0/57 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Corneal edema lasting more than 30 days	0.00% 0/57 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	1.8% 1/57 • Number of events 1 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Wound leak or dehisence	0.00% 0/57 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	1.8% 1/57 • Number of events 1 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.
Eye disorders Intraocular lens capture	0.00% 0/57 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.	1.8% 1/57 • Number of events 1 • Ocular adverse events occurring the day after enrollment until the follow-up visit at 10.5 years of age are reported.