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).
Be at least 8 years of age or older, male or female, of any race.
Have a diagnosis of Down syndrome or other cognitive, developmental, or medical conditions that precludes the subject from reliably following instructions or performing some of the study examination procedures.
Have a diagnosis of keratoconus, pellucid marginal degeneration, progressive ectasia after previous CXL treatment, other ectatic condition, or forme fruste keratoconus based on topography, tomography, and slit lamp examination.
Provide written informed consent and a signed HIPAA form. Pediatric subjects less than 14 years of age must sign an assent, and a parent or legal guardian must sign an informed consent. If the subject has impaired consent capacity, determined by the consenter, the consent form must be signed by the subject's legally authorized representative on behalf of the subject.
Normal corneal topography.
A history of previous corneal transplant in the study eye.
Minimum corneal thickness < 300 (measured by Pentacam and Ultrasound) at the screening exam.
History of, or active, corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
Single group
Epi-ON corneal cross-linking (CXL)
Combination productCorneal 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.
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.
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.
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.
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.
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.
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