Congenital CataractIATSNCT00212134
Infant Aphakia Treatment Study (IATS)
A study testing Contact lens correction of aphakia and Intraocular lens implantation in people with Congenital Cataract, run by Stanford University at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 210 days
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- Contact lens correction of aphakia and Intraocular lens implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2004to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 210 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Emory Eye Center
Atlanta, Georgia, 30322
Harvard University
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425-2236
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Pediatric Ophthalmology, P.A.
Dallas, Texas, 75225
Duke University Eye Center
Durham, North Carolina, 27710
Baylor University
Houston, Texas, 77030
Indiana University Medical Center
Indianapolis, Indiana, 46202-5175
Miami Children's Hospital
Miami, Florida, 33155
University of Minnesota
Minneapolis, Minnesota, 55455-0501
Vanderbilt University
Nashville, Tennessee, 37232-8808
Stanford University
Palo Alto, California, 94303
Oregon Health and Science University
Portland, Oregon, 97239-4197
About this study
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.
Read the 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.
- Conditions
- Congenital Cataract
- Being tested
- Contact lens correction of aphakia, Intraocular lens implantation
- Keywords
- cataract surgery, intraocular lens, contact lens, infants, aphakia
- Medical subject headings
- Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact lens correction of aphakiaDevice
Also called Silsoft aphakic contact lens, rigid gas permeable contact lens
optical correction of infant surgical aphakia with Contact lens
Intraocular lens implantationDevice
Also called Alcon SA60AT, Alcon MA60AC
optical correction of surgical aphakia with intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| aphakic contact lens | Active comparator | 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. Receives: Device: Contact lens correction of aphakia |
| aphakic intraocular lens | Experimental | 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. Receives: Device: Intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
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.
Measured: Phase 1 - Age 12 months
Visual Acuity - Subjective Assessment at 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.
Measured: Phase 2 - Age 4.5 Years
Visual Acuity - Subjective Assessment at Age 10 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).
Measured: Phase 3 - Age 10.5 Years
Secondary outcomes (5)
Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery
Percent of Patients with 1 or More Intraoperative Complications at Cataract Surgery
Measured: Cataract surgery immediately after enrollment
Percent of Patients With 1 or More Adverse Events
Measured: Study enrollment to age 5 years
Parenting Stress
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.
Measured: Phase 1 - 3 months post surgery
Adherence to Occlusion Therapy
Parental report of the number of hours children wore an patch to occlude the fellow eye.
Measured: Phase 1 - 12 months follow-up
Parenting Stress
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
Measured: Phase 1 - Age 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2004
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (73)Papers the sponsor has linked to this study.
- Other trials for Congenital CataractStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3 is 10.5-year follow-up study since Phase 1. There is no intervention.
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Alcon Research, Bausch & Lomb Incorporated, BSN-JOBST Inc., Eye Care and Cure
- Responsible party
- Principal investigator, Scott Reed Lambert, Stanford University
- Investigators
- Scott Lambert, MD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212134
- Sponsor's protocol ID
- IRB00024837
- Other IDs
- U10EY013272, EY013287, EY013272, NEI-108
- Acronym
- IATS
- Status last verified
- Jul 2024
- First submitted
- 13 Sep 2005
- Last updated
- 24 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bothun ED, Lynn MJ, Lambert SR. Author reply: To PMID 23419803. Ophthalmology. 2014 Oct;121(10):e53. doi: 10.1016/j.ophtha.2014.05.011. Epub 2014 Jun 6. No abstract available.
PubMed 24909820Traboulsi EI, Vanderveen D, Morrison D, Drews-Botsch CD, Lambert SR; Infant Aphakia Treatment Study Group. Associated systemic and ocular disorders in patients with congenital unilateral cataracts: the Infant Aphakia Treatment Study experience. Eye (Lond). 2016 Sep;30(9):1170-4. doi: 10.1038/eye.2016.124. Epub 2016 Jun 17.
PubMed 27315350Drews-Botsch C, Celano M, Cotsonis G, Hartmann EE, Lambert SR; Infant Aphakia Treatment Study Group. Association Between Occlusion Therapy and Optotype Visual Acuity in Children Using Data From the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2016 Aug 1;134(8):863-9. doi: 10.1001/jamaophthalmol.2016.1365.
PubMed 27228110Lambert SR, Plager DA, Lynn MJ, Wilson ME. Visual outcome following the reduction or cessation of patching therapy after early unilateral cataract surgery. Arch Ophthalmol. 2008 Aug;126(8):1071-4. doi: 10.1001/archopht.126.8.1071.
PubMed 18695101Infant Aphakia Treatment Study Group; Lambert SR, Buckley EG, Drews-Botsch C, DuBois L, Hartmann E, Lynn MJ, Plager DA, Wilson ME. The infant aphakia treatment study: design and clinical measures at enrollment. Arch Ophthalmol. 2010 Jan;128(1):21-7. doi: 10.1001/archophthalmol.2009.350.
PubMed 20065212Infant Aphakia Treatment Study Group; Lambert SR, Buckley EG, Drews-Botsch C, DuBois L, Hartmann EE, Lynn MJ, Plager DA, Wilson ME. A randomized clinical trial comparing contact lens with intraocular lens correction of monocular aphakia during infancy: grating acuity and adverse events at age 1 year. Arch Ophthalmol. 2010 Jul;128(7):810-8. doi: 10.1001/archophthalmol.2010.101. Epub 2010 May 10.
PubMed 20457949Plager DA, Lynn MJ, Buckley EG, Wilson ME, Lambert SR; Infant Aphakia Treatment Study Group. Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study. Ophthalmology. 2011 Dec;118(12):2330-4. doi: 10.1016/j.ophtha.2011.06.017. Epub 2011 Sep 16.
PubMed 21925737Morrison DG, Wilson ME, Trivedi RH, Lambert SR, Lynn MJ; Infant Aphakia Treatment Study Group. Infant Aphakia Treatment Study: effects of persistent fetal vasculature on outcome at 1 year of age. J AAPOS. 2011 Oct;15(5):427-31. doi: 10.1016/j.jaapos.2011.06.004.
PubMed 22108353Wilson ME, Trivedi RH, Morrison DG, Lambert SR, Buckley EG, Plager DA, Lynn MJ; Infant Aphakia Treatment Study Group. The Infant Aphakia Treatment Study: evaluation of cataract morphology in eyes with monocular cataracts. J AAPOS. 2011 Oct;15(5):421-6. doi: 10.1016/j.jaapos.2011.05.016.
PubMed 22108352Drews-Botsch CD, Hartmann EE, Celano M; Infant Aphakia Treatment Study Group. Predictors of adherence to occlusion therapy 3 months after cataract extraction in the Infant Aphakia Treatment Study. J AAPOS. 2012 Apr;16(2):150-5. doi: 10.1016/j.jaapos.2011.12.149.
PubMed 22525171Beck AD, Freedman SF, Lynn MJ, Bothun E, Neely DE, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-related adverse events in the Infant Aphakia Treatment Study: 1-year results. Arch Ophthalmol. 2012 Mar;130(3):300-5. doi: 10.1001/archophthalmol.2011.347. Epub 2011 Nov 14.
PubMed 22084157VanderVeen DK, Nizam A, Lynn MJ, Bothun ED, McClatchey SK, Weakley DR, DuBois LG, Lambert SR; Infant Aphakia Treatment Study Group. Predictability of intraocular lens calculation and early refractive status: the Infant Aphakia Treatment Study. Arch Ophthalmol. 2012 Mar;130(3):293-9. doi: 10.1001/archophthalmol.2011.358.
PubMed 22411658Russell B, Ward MA, Lynn M, Dubois L, Lambert SR; Infant Aphakia Treatment Study Group. The infant aphakia treatment study contact lens experience: one-year outcomes. Eye Contact Lens. 2012 Jul;38(4):234-9. doi: 10.1097/ICL.0b013e3182562dc0.
PubMed 22669008Lambert SR, Purohit A, Superak HM, Lynn MJ, Beck AD. Long-term risk of glaucoma after congenital cataract surgery. Am J Ophthalmol. 2013 Aug;156(2):355-361.e2. doi: 10.1016/j.ajo.2013.03.013. Epub 2013 Apr 30.
PubMed 23639132Carrigan AK, DuBois LG, Becker ER, Lambert SR; Infant Aphakia Treatment Study Group. Cost of intraocular lens versus contact lens treatment after unilateral congenital cataract surgery: retrospective analysis at age 1 year. Ophthalmology. 2013 Jan;120(1):14-9. doi: 10.1016/j.ophtha.2012.07.049. Epub 2012 Oct 6.
PubMed 23047003
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Aphakia Treatment Study (IATS)
- ClinicalTrials.gov ID
- NCT00212134
- Acronym / sponsor ID
- IATS / IRB00024837
- Conditions
- Congenital Cataract
- Keywords
- cataract surgery, intraocular lens, contact lens, infants, aphakia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Alcon Research, Bausch & Lomb Incorporated, BSN-JOBST Inc., Eye Care and Cure
- Study start
- Dec 2004 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 5 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 3 is 10.5-year follow-up study since Phase 1. There is no intervention.
| Arm | Type | Receives |
|---|---|---|
| aphakic contact lens | Active comparator | Device: Contact lens correction of aphakiaContact 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. |
| aphakic intraocular lens | Experimental | Device: Intraocular lens implantationIntraocular 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. |
Who may qualify
- Ages
- 28 to 210 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contact lens correction of aphakiaAlso: Silsoft aphakic contact lens, rigid gas permeable contact lensoptical correction of infant surgical aphakia with Contact lens | Device | aphakic contact lens |
| Intraocular lens implantationAlso: Alcon SA60AT, Alcon MA60ACoptical correction of surgical aphakia with intraocular lens | Device | aphakic intraocular lens |
Primary outcome
Visual Acuity
Time frame: 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.
Visual Acuity - Subjective Assessment at Age 4.5 Years.
Time frame: 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.
Visual Acuity - Subjective Assessment at Age 10 Years.
Time frame: 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).
5 secondary outcomes
Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery
Time frame: Cataract surgery immediately after enrollment
Percent of Patients With 1 or More Adverse Events
Time frame: Study enrollment to age 5 years
Parenting Stress
Time frame: Phase 1 - 3 months post surgery
Adherence to Occlusion Therapy
Time frame: Phase 1 - 12 months follow-up
Parenting Stress
Time frame: Phase 1 - Age 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24909820Bothun ED, Lynn MJ, Lambert SR. Author reply: To PMID 23419803. Ophthalmology. 2014 Oct;121(10):e53. doi: 10.1016/j.ophtha.2014.05.011. Epub 2014 Jun 6. No abstract available.
- Results publication: PubMed 27315350Traboulsi EI, Vanderveen D, Morrison D, Drews-Botsch CD, Lambert SR; Infant Aphakia Treatment Study Group. Associated systemic and ocular disorders in patients with congenital unilateral cataracts: the Infant Aphakia Treatment Study experience. Eye (Lond). 2016 Sep;30(9):1170-4. doi: 10.1038/eye.2016.124. Epub 2016 Jun 17.
- Results publication: PubMed 27228110Drews-Botsch C, Celano M, Cotsonis G, Hartmann EE, Lambert SR; Infant Aphakia Treatment Study Group. Association Between Occlusion Therapy and Optotype Visual Acuity in Children Using Data From the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2016 Aug 1;134(8):863-9. doi: 10.1001/jamaophthalmol.2016.1365.
- Results publication: PubMed 18695101Lambert SR, Plager DA, Lynn MJ, Wilson ME. Visual outcome following the reduction or cessation of patching therapy after early unilateral cataract surgery. Arch Ophthalmol. 2008 Aug;126(8):1071-4. doi: 10.1001/archopht.126.8.1071.
- Results publication: PubMed 20065212Infant Aphakia Treatment Study Group; Lambert SR, Buckley EG, Drews-Botsch C, DuBois L, Hartmann E, Lynn MJ, Plager DA, Wilson ME. The infant aphakia treatment study: design and clinical measures at enrollment. Arch Ophthalmol. 2010 Jan;128(1):21-7. doi: 10.1001/archophthalmol.2009.350.
- Results publication: PubMed 20457949Infant Aphakia Treatment Study Group; Lambert SR, Buckley EG, Drews-Botsch C, DuBois L, Hartmann EE, Lynn MJ, Plager DA, Wilson ME. A randomized clinical trial comparing contact lens with intraocular lens correction of monocular aphakia during infancy: grating acuity and adverse events at age 1 year. Arch Ophthalmol. 2010 Jul;128(7):810-8. doi: 10.1001/archophthalmol.2010.101. Epub 2010 May 10.
- Results publication: PubMed 21925737Plager DA, Lynn MJ, Buckley EG, Wilson ME, Lambert SR; Infant Aphakia Treatment Study Group. Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study. Ophthalmology. 2011 Dec;118(12):2330-4. doi: 10.1016/j.ophtha.2011.06.017. Epub 2011 Sep 16.
- Results publication: PubMed 22108353Morrison DG, Wilson ME, Trivedi RH, Lambert SR, Lynn MJ; Infant Aphakia Treatment Study Group. Infant Aphakia Treatment Study: effects of persistent fetal vasculature on outcome at 1 year of age. J AAPOS. 2011 Oct;15(5):427-31. doi: 10.1016/j.jaapos.2011.06.004.
- Results publication: PubMed 22108352Wilson ME, Trivedi RH, Morrison DG, Lambert SR, Buckley EG, Plager DA, Lynn MJ; Infant Aphakia Treatment Study Group. The Infant Aphakia Treatment Study: evaluation of cataract morphology in eyes with monocular cataracts. J AAPOS. 2011 Oct;15(5):421-6. doi: 10.1016/j.jaapos.2011.05.016.
- Results publication: PubMed 22525171Drews-Botsch CD, Hartmann EE, Celano M; Infant Aphakia Treatment Study Group. Predictors of adherence to occlusion therapy 3 months after cataract extraction in the Infant Aphakia Treatment Study. J AAPOS. 2012 Apr;16(2):150-5. doi: 10.1016/j.jaapos.2011.12.149.
- Results publication: PubMed 22084157Beck AD, Freedman SF, Lynn MJ, Bothun E, Neely DE, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-related adverse events in the Infant Aphakia Treatment Study: 1-year results. Arch Ophthalmol. 2012 Mar;130(3):300-5. doi: 10.1001/archophthalmol.2011.347. Epub 2011 Nov 14.
- Results publication: PubMed 22411658VanderVeen DK, Nizam A, Lynn MJ, Bothun ED, McClatchey SK, Weakley DR, DuBois LG, Lambert SR; Infant Aphakia Treatment Study Group. Predictability of intraocular lens calculation and early refractive status: the Infant Aphakia Treatment Study. Arch Ophthalmol. 2012 Mar;130(3):293-9. doi: 10.1001/archophthalmol.2011.358.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Lambert, MD study chair
Stanford University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact lens correction of aphakia and Intraocular lens implantation in people with Congenital Cataract, run by Stanford University at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: Phase 1 - Age 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00212134, which also lists 73 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.