Ectasia
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 ectasia.
Interventions
Only subjects assigned to the treatment group will receive treatment with the UV Light
DRUGRiboflavin
Both treatment and sham groups will receive riboflavin
Sponsors
Topcon Medical Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 Years of age or older * Diagnosis of Ectasia * Presence of central or inferior steepening * Topography consistent with ectasia * BSCVA 20/20 or worse * If contact lens wearer; removal of contact lenses for required period of time * Signed informed consent * Willingness and ability to comply with schedule for follow-up visits
Exclusion criteria
* Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision * History of chemical injury or delayed epithelial healing * A known sensitivity to study medications * Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests * A condition that would interfere with or prolong epithelial healing * Presence or history of any other condition or finding that makes the patient unsuitable for treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Corneal Curvature | 6 Months |
Countries
United States
Participant flow
Recruitment details
The recruitment period started December 2010 and ended June 2012 at medical clinics throughout the country.
Pre-assignment details
Enrolled participants were excluded from the clinical trial because they failed to meet one or more the inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| CXL Treatment VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light
Riboflavin : Both treatment and sham groups will receive riboflavin | 35 |
| Sham Control Riboflavin : Both treatment and sham groups will receive riboflavin | 37 |
| Total | 72 |
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 | 37 participants | 35 participants | 72 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 / 35 | 0 / 37 |
| serious Total, serious adverse events | 0 / 35 | 0 / 37 |
Outcome results
Primary
Changes in Corneal Curvature
Time frame: 6 Months
Population: The CXL-002 study was terminated and data analysis was not done. The sponsor, Topcon Medical Systems, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.