Corneal Collagen Cross-Linking for Ectasia (CXL)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Corneal Collagen Cross-linking (CXL) Treatment Group riboflavin ophthalmic solution and UVA irradiation |
Drug: riboflavin ophthalmic solution
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
Device: UVA Irradiation
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Other Names:
|
Sham Comparator: Control Group riboflavin opthalmic solution without UVA irradiation |
Drug: riboflavin ophthalmic solution
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Shiley Eye Center | La Jolla | California | United States | 92093 |
2 | Gordon -Weiss Vision Institute | San Diego | California | United States | 91222 |
3 | Center for Excellence in Eye Care | Miami | Florida | United States | 33176 |
4 | Price Vision Group | Indianapolis | Indiana | United States | 46260 |
5 | Durrie Vision | Kansas City | Kansas | United States | 66211 |
6 | Wilmer Eye Institute at Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
7 | Minnesota Eye Consultants | Minneapolis | Minnesota | United States | 55404 |
8 | Cornea & Laser Eye Institute; Hersh Vision Group | Teaneck | New Jersey | United States | 07666 |
9 | Edward Harkness Eye Institute at Columbia University Medical Center | New York | New York | United States | 10032 |
10 | Ophthalmic Consultants of Long Island | Rockville Centre | New York | United States | 11570 |
Sponsors and Collaborators
- Glaukos Corporation
Investigators
- Principal Investigator: Peter Hersh, MD, Cornea and Laser Eye Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UVX-003
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Corneal Collagen Cross-linking (CXL) Treatment Group | Control Group |
---|---|---|
Arm/Group Description | riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes | riboflavin opthalmic solution without UVA irradiation |
Period Title: Overall Study | ||
STARTED | 67 | 63 |
COMPLETED | 56 | 48 |
NOT COMPLETED | 11 | 15 |
Baseline Characteristics
Arm/Group Title | Corneal Collagen Cross-linking (CXL) Treatment Group | Control Group | Total |
---|---|---|---|
Arm/Group Description | riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes | riboflavin opthalmic solution without UVA irradiation | Total of all reporting groups |
Overall Participants | 67 | 63 | 130 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
67
100%
|
63
100%
|
130
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||
Female |
23
34.3%
|
16
25.4%
|
39
30%
|
Male |
44
65.7%
|
47
74.6%
|
91
70%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
9
13.4%
|
9
14.3%
|
18
13.8%
|
Not Hispanic or Latino |
18
26.9%
|
18
28.6%
|
36
27.7%
|
Unknown or Not Reported |
40
59.7%
|
36
57.1%
|
76
58.5%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
3
4.5%
|
4
6.3%
|
7
5.4%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
7
10.4%
|
5
7.9%
|
12
9.2%
|
White |
50
74.6%
|
45
71.4%
|
95
73.1%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
7
10.4%
|
9
14.3%
|
16
12.3%
|
Outcome Measures
Title | Mean Change From Baseline in Maximum Keratometry (Kmax) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Corneal Collagen Cross-linking (CXL) Treatment Group | Control Group |
---|---|---|
Arm/Group Description | riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes | riboflavin opthalmic solution without UVA irradiation |
Measure Participants | 67 | 63 |
Mean (Standard Deviation) [diopters] |
-0.5
(2.2)
|
0.5
(2.3)
|
Adverse Events
Time Frame | 3 months | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Corneal Collagen Cross-linking (CXL) Treatment Group | Control Group | ||
Arm/Group Description | riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes | riboflavin opthalmic solution without UVA irradiation | ||
All Cause Mortality |
||||
Corneal Collagen Cross-linking (CXL) Treatment Group | Control Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Corneal Collagen Cross-linking (CXL) Treatment Group | Control Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/67 (1.5%) | 0/63 (0%) | ||
Eye disorders | ||||
Corneal epithelium defect | 1/67 (1.5%) | 1 | 0/63 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Corneal Collagen Cross-linking (CXL) Treatment Group | Control Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 59/67 (88.1%) | 21/63 (33.3%) | ||
Eye disorders | ||||
Corneal opacity | 40/67 (59.7%) | 45 | 1/63 (1.6%) | 1 |
Eye pain | 18/67 (26.9%) | 19 | 0/63 (0%) | 0 |
Corneal epithelium defect | 14/67 (20.9%) | 18 | 2/63 (3.2%) | 2 |
Punctate keratitis | 13/67 (19.4%) | 13 | 2/63 (3.2%) | 3 |
Dry eye | 11/67 (16.4%) | 12 | 3/63 (4.8%) | 3 |
Photophobia | 11/67 (16.4%) | 12 | 0/63 (0%) | 0 |
Vision blurred | 11/67 (16.4%) | 11 | 4/63 (6.3%) | 4 |
Eye irritation | 7/67 (10.4%) | 7 | 0/63 (0%) | 0 |
Visual acuity reduced | 7/67 (10.4%) | 7 | 1/63 (1.6%) | 1 |
Corneal striae | 5/67 (7.5%) | 6 | 3/63 (4.8%) | 3 |
Lacrimation increased | 5/67 (7.5%) | 5 | 0/63 (0%) | 0 |
Ocular discomfort | 5/67 (7.5%) | 5 | 0/63 (0%) | 0 |
Conjunctival hyperaemia | 4/67 (6%) | 4 | 3/63 (4.8%) | 3 |
Eyelid oedema | 4/67 (6%) | 4 | 1/63 (1.6%) | 1 |
anterior chamber flare | 3/67 (4.5%) | 3 | 1/63 (1.6%) | 1 |
Foreign body sensation in eyes | 3/67 (4.5%) | 3 | 1/63 (1.6%) | 1 |
keratitis | 3/67 (4.5%) | 3 | 0/63 (0%) | 0 |
Meibomian gland dyisfunction | 3/67 (4.5%) | 4 | 2/63 (3.2%) | 2 |
Ocular hyperaemia | 3/67 (4.5%) | 3 | 1/63 (1.6%) | 1 |
Visual impairment | 3/67 (4.5%) | 3 | 1/63 (1.6%) | 1 |
Anterior chamber cell | 2/67 (3%) | 2 | 0/63 (0%) | 0 |
Asthenopia | 2/67 (3%) | 2 | 0/63 (0%) | 0 |
Corneal oedema | 2/67 (3%) | 2 | 0/63 (0%) | 0 |
Glare | 2/67 (3%) | 2 | 0/63 (0%) | 0 |
Halo vision | 2/67 (3%) | 2 | 0/63 (0%) | 0 |
Corneal abrasion | 2/67 (3%) | 2 | 0/63 (0%) | 0 |
Nervous system disorders | ||||
Headache | 5/67 (7.5%) | 5 | 1/63 (1.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Site has the right to publish or communicate study results upon the earlier of: (a) publication of a multi-center publication of the Study results coordinated by Sponsor; or (b) submission of the Study data by Sponsor to the FDA; provided that the Sponsor reviews the proposed communication of results within ninety (90) days in advance of its release. Sponsor can request delay of publication or data release to allow for filing of patent application prior to the publication or release.
Results Point of Contact
Name/Title | Vineeta Belanger, VP of Clinical Affairs |
---|---|
Organization | Avedro, Inc. |
Phone | 781-768-3459 |
vbelanger@avedro.com |
- UVX-003