The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred. CXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day. It is designed to stop the progression of disease by strengthening the cornea. Study participants will be 8 years of age or older and have a diagnosis of Down syndrome. The main question it aims to answer is: * Does CXL help prevent or slow the progression of someone's corneal condition and vision loss? Participants will: * Attend up to a total of 7 in office visits over the course of 6 months, where several eye and vision tests will be given. Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light for 20 minutes).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
225
Corneal cross-linking involves the following steps: * applying riboflavin (Vitamin B2 eye drops) to the eye, then * exposing the eye to ultraviolet (UV-A) light for 20 minutes.
Woolfson Eye Institute
Atlanta, Georgia, United States
RECRUITINGWoolfson Eye Institute
Atlanta, Georgia, United States
RECRUITINGWoolfson Eye Institute
Canton, Georgia, United States
RECRUITINGWoolfson Eye Institute
Cumming, Georgia, United States
RECRUITINGWoolfson Eye Institute
Douglasville, Georgia, United States
RECRUITINGWoolfson Eye Institute
Lawrenceville, Georgia, United States
RECRUITINGWoolfson Eye Institute
Marietta, Georgia, United States
RECRUITINGWoolfson Eye Institute
Snellville, Georgia, United States
RECRUITINGWoolfson Eye Institute
Asheville, North Carolina, United States
RECRUITINGWoolfson Eye Institute
Chattanooga, Tennessee, United States
RECRUITING...and 2 more locations
The primary outcome measures for efficacy is corneal curvature, as measured by Kmax with the Pentacam, in the treated eyes.
Primarily using measurements to assess improvement of vision.
Time frame: From enrollment to the end of treatment at 6 months.
Improvement of vision as assessed by corrected distance visual acuity (CDVA).
Change in CDVA compared to the baseline examination will be evaluated at 6 months postoperatively. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Time frame: From enrollment to the end of treatment at 6 months.
Improvement in vision as measured by high order aberrations (HOA).
At the Sponsor-Investigator's discretion, the change in HOA from baseline may be evaluated at 6 months postoperatively for the eyes that underwent preoperative and postoperative wavefront testing. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Time frame: From enrollment until end of follow-up period at 6 months.
Improvement in vision as assessed by change in coma.
At the Sponsor-Investigator's discretion, the change in coma from baseline may be evaluated at 6 months postoperatively for the eyes that underwent preoperative and postoperative wavefront testing. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Time frame: Enrollment through the follow-up phase at 6 months.
Improved vision as assessed by Uncorrected Visual Acuity (UCVA).
Change in UCVA compared to the baseline examination will be evaluated at 6 months postoperatively. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Time frame: Enrollment through the end of the follow-up period at 6 months.
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