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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:
Participants will:
Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light for 20 minutes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled and treated subject arm | Experimental | Epi-ON corneal cross-linking (CXL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epi-ON corneal cross-linking (CXL) | Combination Product | Corneal cross-linking involves the following steps:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From enrollment to the end of treatment at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment until end of follow-up period at 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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.
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent the possibility of improved vision, for example:
A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
Nystagmus or any other condition that would prevent a steady gaze during the crosslinking treatment or other diagnostic tests.
If female, pregnant, lactating or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of either eye during the course of the study. [NOTE: If female and capable of becoming pregnant, must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue one month following treatment. ]
7. Inability to remove soft or scleral contact lenses at least 3 days before initial and follow-up examinations.
8. Inability to remove rigid gas-permeable contact lenses at least 2 weeks before initial and follow-up examinations.
9. Inability to return for required postoperative examinations. 10. Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for crosslinking or study participation or may confound the outcome of the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LuAnn Bryant | Contact | 770-804-1684 | 155 | lbryant@woolfsoneye.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woolfson Eye Institute | Recruiting | Atlanta | Georgia | 30328 | United States |
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| 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. | 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. | Enrollment through the end of the follow-up period at 6 months. |
| Woolfson Eye Institute | Recruiting | Atlanta | Georgia | 30349 | United States |
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| Woolfson Eye Institute | Recruiting | Canton | Georgia | 30114 | United States |
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| Woolfson Eye Institute | Recruiting | Cumming | Georgia | 30041 | United States |
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| Woolfson Eye Institute | Recruiting | Douglasville | Georgia | 30134 | United States |
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| Woolfson Eye Institute | Recruiting | Lawrenceville | Georgia | 30043 | United States |
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| Woolfson Eye Institute | Recruiting | Marietta | Georgia | 30066 | United States |
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| Woolfson Eye Institute | Recruiting | Snellville | Georgia | 30078 | United States |
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| Woolfson Eye Institute | Recruiting | Asheville | North Carolina | 28803 | United States |
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| Woolfson Eye Institute | Recruiting | Chattanooga | Tennessee | 37421 | United States |
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| Woolfson Eye Institute | Recruiting | Johnson City | Tennessee | 37615 | United States |
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| Woolfson Eye Institute | Recruiting | Knoxville | Tennessee | 37922 | United States |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D007640 | Keratoconus |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000094504 | Corneal Cross-Linking |
| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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