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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corneal Collagen Cross-linking (CXL) Treatment Group | Active Comparator | riboflavin ophthalmic solution and UVA irradiation |
|
| Control Group | Sham Comparator | riboflavin opthalmic solution without UVA irradiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| riboflavin ophthalmic solution | Drug | riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline,12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Hersh, MD | Cornea and Laser Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiley Eye Center | La Jolla | California | 92093 | United States | ||
| Gordon -Weiss Vision Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22692521 | Derived | Greenstein SA, Fry KL, Hersh PS. Effect of topographic cone location on outcomes of corneal collagen cross-linking for keratoconus and corneal ectasia. J Refract Surg. 2012 Jun;28(6):397-405. doi: 10.3928/1081597X-20120518-02. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control Group | riboflavin opthalmic solution without UVA irradiation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | diopters | baseline,12 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal epithelium defect | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal opacity | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vineeta Belanger, VP of Clinical Affairs | Avedro, Inc. | 781-768-3459 | vbelanger@avedro.com |
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| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005128 | Eye Diseases |
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| UVA Irradiation | Device | UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes |
|
|
| San Diego |
| California |
| 91222 |
| United States |
| Center for Excellence in Eye Care | Miami | Florida | 33176 | United States |
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
| Durrie Vision | Kansas City | Kansas | 66211 | United States |
| Wilmer Eye Institute at Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Minnesota Eye Consultants | Minneapolis | Minnesota | 55404 | United States |
| Cornea & Laser Eye Institute; Hersh Vision Group | Teaneck | New Jersey | 07666 | United States |
| Edward Harkness Eye Institute at Columbia University Medical Center | New York | New York | 10032 | United States |
| Ophthalmic Consultants of Long Island | Rockville Centre | New York | 11570 | United States |
| Withdrawal by Subject |
|
riboflavin opthalmic solution without UVA irradiation
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 1 |
| 67 |
| 59 |
| 67 |
| EG001 | Control Group | riboflavin opthalmic solution without UVA irradiation | 0 | 63 | 21 | 63 |
| Eye pain | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Corneal epithelium defect | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Corneal striae | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| anterior chamber flare | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| keratitis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Meibomian gland dyisfunction | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Anterior chamber cell | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Asthenopia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Corneal oedema | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Glare | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Halo vision | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Corneal abrasion | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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.