Keratoconus and Ectasia
Conditions
Brief summary
The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.
Interventions
DRUGRiboflavin
Riboflavin is a solution that will be delivered to the treatment area
This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area
Sponsors
Topcon Medical Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 12 years of age or older * Diagnosis of Keratoconus or Ectasia * Central or Inferior steepening on the Pentacam map * Topography consistent with Keratoconus or Ectasia * BSCVA 20/20 or worse * Removal of contact lenses for 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 * Corneal pachymentry equal to or greater and 400 * Previous ocular condition in the eyes to be treated that may predispose the eye for future complications * A history of chemical injury or delayed healing * Pregnancy * A known sensitivity to the study medications * Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests * Presence or history of any other condition or finding that makes the patient unsuitable as a candidate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Corneal Curvature | 24 MO |
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 All eyes to be treated with riboflavin and UV light | 372 |
| Total | 372 |
Baseline characteristics
| Characteristic | CXL Treatment |
|---|---|
| Age, Categorical <=18 years | NA Participants |
| Age, Categorical >=65 years | NA Participants |
| Age, Categorical Between 18 and 65 years | NA Participants |
| Age, Continuous | NA years |
| Region of Enrollment United States | 372 participants |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 372 |
| serious Total, serious adverse events | 0 / 372 |
Outcome results
Primary
Changes in Corneal Curvature
Time frame: 24 MO
Population: The CXL-003 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.