Keratoconus
Conditions
Brief summary
The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL), when used to treat keratoconus.
Interventions
DEVICEThe VEGA UV-A Illumination System
This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area
DRUGRiboflavin
Riboflavin is a solution that will be delivered to the treatment area
Sponsors
Topcon Medical Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 12 years of age or older * Having a diagnosis of keratoconus * Presence of central or inferior steepening * Topography consistent with keratoconus * Presence of one or more slit lamp or retinoscopy findings associated with keratoconus * Contact lens wearers only:Removal of contact lenses for the required period of time * Signed written informed consent * Willingness and ability to comply with schedule for follow-up visits
Exclusion criteria
* For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated * Corneal pachymetry ≤ 400 microns * Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision * A history of chemical injury or delayed epithelial healing in the eye(s) to be treated. * Pregnancy (including plan to become pregnant) or lactation during the course of the study * A known sensitivity to study medications * Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests * A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing. * Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Corneal Curvature. | 6 Months |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from August, 2010 to December 2011 from medical clinics throughout the country.
Pre-assignment details
Patients that were excluded from the clinical trial were considered screen failures due to not meeting one or more of the inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| CXL Treatment Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light. | 61 |
| Sham Control Eyes in the control group will be treated with riboflavin only. | 66 |
| Total | 127 |
Baseline characteristics
| Characteristic | Sham Control | CXL Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | NA Participants | NA Participants | NA Participants |
| Age, Categorical >=65 years | NA Participants | NA Participants | NA Participants |
| Age, Categorical Between 18 and 65 years | NA Participants | NA Participants | NA Participants |
| Age, Continuous | NA years | NA years | NA years |
| Region of Enrollment United States | NA participants | NA participants | NA participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 61 | 0 / 66 |
| serious Total, serious adverse events | 0 / 61 | 0 / 66 |
Outcome results
Primary
Change in Corneal Curvature.
Time frame: 6 Months
Population: The CXL-001 study was completed but data analysis was not done. Prior to data analysis, the sponsor, Topcon, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.