Progressive Keratoconus
Conditions
Keywords
keratoconus, cross-linking, riboflavin, UVA light, cornea
Brief summary
Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.
Detailed description
This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.
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 keratoconus * Documented progression over previous 24 months * Decreased BSCVA * Must complete all study visits
Exclusion criteria
* Prior corneal surgery or Intacs * History of delayed wound healing
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 | 73 |
| Control Group riboflavin ophthalmic solution without UVA irradiation | 74 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 8 |
Baseline characteristics
| Characteristic | Corneal Collagen Cross-linking (CXL) Treatment Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 3 Participants | 10 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants | 71 Participants | 137 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 36 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 35 Participants | 35 Participants | 70 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 7 Participants | 14 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 | 12 Participants | 5 Participants | 17 Participants |
| Race (NIH/OMB) White | 54 Participants | 61 Participants | 115 Participants |
| Sex: Female, Male Female | 19 Participants | 24 Participants | 43 Participants |
| Sex: Female, Male Male | 54 Participants | 50 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 57 / 73 | 25 / 74 |
| serious Total, serious adverse events | 0 / 73 | 3 / 74 |
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
Population: The ITT (intent to treat) population consisted of all treated subjects, analyzed according to the treatment actually received. For the sham study eyes that received CXL treatment after baseline, the last Kmax measurement recorded prior to receiving CXL treatment was used in the analysis for later time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corneal Collagen Cross-linking (CXL) Treatment Group | Mean Change From Baseline in Maximum Keratometry (Kmax) | -1.7 diopters | Standard Deviation 4.7 |
| Control Group | Mean Change From Baseline in Maximum Keratometry (Kmax) | 0.6 diopters | Standard Deviation 2.8 |