Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders
Study Details
Study Description
Brief Summary
This is a prospective, randomized, single investigative site study to compare the safety and effectiveness of Epi-OFF CXL treatment (performed using Ricrolin+ and VEGA UV-A system) compared to Epi-ON CXL (performed using Ricrolin+ and VEGA UV-A system) in eyes with keratoconus and other corneal ectatic disorders.Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Epi-OFF CXL The Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment. |
Drug: Ricrolin+
1 to 2 drops of Ricrolin+ will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the Ricrolin+ pre-treatment period, the eye will be examined at the slit lamp to detect the presence of a yellow flare in the anterior chamber, indicating adequate riboflavin saturation of the corneal tissue. If the yellow flare is not detected, Ricrolin+ will continue to be instilled 1 drop every 2 minutes for an additional 5 to 10 minutes; and the anterior chamber will be rechecked for yellow flare. This process will be repeated as necessary. During the irradiation period, 1 to 2 drops of Ricrolin+ to cover the cornea (in the same manner as during the riboflavin pre-treatment) before the start of irradiation and every 5 minutes during irradiation until irradiation is complete.
Device: VEGA UV-A system
The VEGA light will be administered for 30 minutes. The VEGA light will stop automatically every 5 minutes for Ricrolin+ administration.
|
| Active Comparator: Epi-ON CXL The Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment. |
Drug: Ricrolin+
1 to 2 drops of Ricrolin+ will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the Ricrolin+ pre-treatment period, the eye will be examined at the slit lamp to detect the presence of a yellow flare in the anterior chamber, indicating adequate riboflavin saturation of the corneal tissue. If the yellow flare is not detected, Ricrolin+ will continue to be instilled 1 drop every 2 minutes for an additional 5 to 10 minutes; and the anterior chamber will be rechecked for yellow flare. This process will be repeated as necessary. During the irradiation period, 1 to 2 drops of Ricrolin+ to cover the cornea (in the same manner as during the riboflavin pre-treatment) before the start of irradiation and every 5 minutes during irradiation until irradiation is complete.
Device: VEGA UV-A system
The VEGA light will be administered for 30 minutes. The VEGA light will stop automatically every 5 minutes for Ricrolin+ administration.
|
Outcome Measures
Primary Outcome Measures
- Mean change in corneal curvature [Baseline, 6 Months, and 12 Months]
Percentage of eyes that had a greater than 2D increase in Kmax measured by the OPD-Scan III
Secondary Outcome Measures
- Change in manifest refraction spherical equivalent [Baseline, 6 Months, and 12 Months]
Change in refraction
- Change in best-corrected visual acuity (BSCVA) [Baseline, 6 Months, and 12 Months]
Percentage of eyes that had a loss of 2 or more lines in BSCVA
- Change in uncorrected-visual acuity (UCVA) [Baseline, 6 Months, and 12 Months]
- Change in thinnest pachymetry [Baseline, 6 Months, and 12 Months]
measured by ultrasound
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be at least 12 years of age or older, male or female, of any race.
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Having a diagnosis of keratoconus or other corneal ectatic disorder.
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Presence of central or inferior steepening on the topography map.
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Axial topography consistent with keratoconus or other corneal ectatic disorder.
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For eyes diagnosed with keratoconus, presence of one or more slit lamp findings associated with keratoconus, such as:
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Scissoring of the retinoscopic reflex
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Fleischer ring
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Vogt striae
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Corneal thinning e .Corneal scarring
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BSCVA 20/20 or worse.
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Subject is willing to have CXL performed by the Epi-OFF or Epi-ON techniques.
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Provide written informed consent and a signed HIPPA form. Pediatric subjects less than 14 years of age must sign an assent and a parent or legal guardian must sign an informed consent.
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Willingness and ability to follow all instructions and comply with schedule for follow-up visits.
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If female and capable of becoming pregnant, must not be lactating or pregnant and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue o one month following treatment.
Exclusion Criteria:
-
One of the randomized CXL techniques (Epi-OFF or Epi-ON) is contraindicated or, in the investigator's clinical judgment, is not able to be performed in the study eye.
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Study eye keratoconus severity is classified as being normal or atypical normal based on the OPD-Scan III keratoconus classification indices.
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A history of previous corneal transplant in the study eye.
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A history of prior CXL in the study eye.
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Corneal pachymetry < 375 microns at the thinnest point as measured by ultrasound pachymetry in the study eye before epithelium removal. [NOTE: Eyes with corneal pachymetry between <375 microns and 325 microns may be enrolled in the compassionate use group.]
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Presence of Intacs or corneal rings or segments in the study eye.
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Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications or prevent the possibility of improved vision, for example:
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History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
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Clinically significant corneal scarring in the treatment zone unrelated to keratoconus.
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Eyes which are aphakic.
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Eyes which are pseudophakic and do not have a UV blocking lens implanted.
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A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
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Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests.
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If female, pregnant, nursing or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of, either eye during the course of the study.
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A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing, including a history of chemical injury or delayed epithelial healing in the study eye.
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Presence or history or any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Sight | Sacramento | California | United States | 95816 |
Sponsors and Collaborators
- Center for Sight, Sacramento, CA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CFS-CXL-001