Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212134
Status:
COMPLETED
Last Update Posted:
2022-07-07
First Post:
2005-09-13
Brief Title:
Infant Aphakia Treatment Study IATS
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Infant Aphakia Treatment Study IATS
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IATS
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
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 105 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 105 years because it will provide a more accurate assessment of visual acuity and will allow us to diagnosis most cases of glaucoma
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 105 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 105 years because it will provide a more accurate assessment of visual acuity and will allow us to diagnosis most cases of glaucoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NEI-108 | OTHER | Other | httpsreporternihgovquickSearchU10EY013272 |
| U10EY013272 | NIH | None | None |
| EY013287 | OTHER_GRANT | None | None |
| EY013272 | OTHER_GRANT | None | None |