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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 at least 8 years of age or older and have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UVA 18 minute | Experimental | Subjects who meet the inclusion criteria and provide informed consent will be randomized to receive UVA irradiation with 15-second off-on cycling for either 18 minutes or 24 minutes |
|
| UVA 24 minute | Experimental | Subjects who meet the inclusion criteria and provide informed consent will be randomized to receive UVA irradiation with 15-second off-on cycling for either 18 minutes or 24 minutes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epi-ON corneal cross-linking | 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 and CDVA. | The change in keratometry (Kmax) and corrected visual acuity from baseline will be evaluated at 6 months for all eyes treated. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests. The change in Kmax and corrected visual acuity from baseline will be evaluated at 6 months. | From enrollment to the end of treatment at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in UCVA compared to the baseline examination will be used as a Secondary outcome measurement. | 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. | 6 months |
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Inclusion Criteria:
Subjects in whom both the subject and study eye meet all of the following criteria are candidates for the study:
Exclusion Criteria:
Subjects in whom the subject or study eye meets one or more of the following criteria will be excluded from the randomized cohort of the study:
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, nursing 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.
Inability to remove soft or scleral contact lenses at least 3 days before initial and follow-up examinations.
Inability to remove rigid gas-permeable contact lenses at least 2 weeks before initial and follow-up examinations.
Inability to return for required postoperative examinations.
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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| 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. |
| 6 months |
| 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. | 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 |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| 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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