Ectasia
Conditions
Keywords
ectasia, cross-linking, crosslinking, cornea, riboflavin, UVA
Brief summary
Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.
Detailed description
Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.
Interventions
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
DEVICEUVA Irradiation
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Sponsors
Glaukos Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ectasia after refractive surgery * Documented ectasia on Pentacam or topography map * BSCVA worse than 20/20 * Must complete all study visits
Exclusion criteria
* History of delayed wound healing * History of corneal melt or corneal dystrophy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Maximum Keratometry (Kmax) | baseline,12 months | The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Corneal Collagen Cross-linking (CXL) Treatment Group riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes | 67 |
| Control Group riboflavin opthalmic solution without UVA irradiation | 63 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 3 |
| Overall Study | Other | 5 | 7 |
| Overall Study | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Corneal Collagen Cross-linking (CXL) Treatment Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 63 Participants | 130 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 18 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 40 Participants | 36 Participants | 76 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) White | 50 Participants | 45 Participants | 95 Participants |
| Sex: Female, Male Female | 23 Participants | 16 Participants | 39 Participants |
| Sex: Female, Male Male | 44 Participants | 47 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 59 / 67 | 21 / 63 |
| serious Total, serious adverse events | 1 / 67 | 0 / 63 |
Outcome results
Primary
Mean Change From Baseline in Maximum Keratometry (Kmax)
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
Time frame: baseline,12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corneal Collagen Cross-linking (CXL) Treatment Group | Mean Change From Baseline in Maximum Keratometry (Kmax) | -0.5 diopters | Standard Deviation 2.2 |
| Control Group | Mean Change From Baseline in Maximum Keratometry (Kmax) | 0.5 diopters | Standard Deviation 2.3 |