Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia
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ClinicalTrials.gov Identifier: NCT01464268 |
Recruitment Status :
Active, not recruiting
First Posted : November 3, 2011
Last Update Posted : January 26, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Keratoconus Corneal Ectasia | Drug: Riboflavin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia |
Study Start Date : | November 2011 |
Estimated Primary Completion Date : | February 2021 |
Estimated Study Completion Date : | February 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Riboflavin drops every minute
Administration of riboflavin every 2 minutes for the duration of UV exposure.
|
Drug: Riboflavin
Administration of riboflavin every 1 minute for the duration of UV exposure.
Other Name: Riboflavin without Dextran |
Active Comparator: Riboflavin drops every 2 minutes
Administration of riboflavin every 1 minute for the duration of UV exposure.
|
Drug: Riboflavin
Administration of riboflavin every 2 minutes for the duration of UV exposure.
Other Name: Riboflavin without dextran |
- Maximum Keratometry [ Time Frame: 12 months ]The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized to the two treatment groups. As a secondary analysis of this endpoint, the change in maximum keratometry (Kmax) from baseline will be evaluated at 1, 3 and 6 month for all eyes
- Manifest refraction [ Time Frame: 12 months ]The change in manifest refraction spherical equivalent from baseline will be evaluated at 12 months. As a secondary analysis of this endpoint, a repeated measures analysis of variance will be conducted to assess the profile of the treatments across time at 1,3, and 6 months to look at the effect of wound healing on this variable.
- Visual Acuity [ Time Frame: 12 months ]Change in BSCVA (best spectacle corrected visual acuity) and UCVA (uncorrected visual acuity) compared to the baseline examination will be evaluated at 12 months postoperatively. As a secondary analysis of this endpoint, data across time from 1, 3, and 6 months following the CXL procedure will be analyzed.
- Endothelial cell density [ Time Frame: 12 months ]Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to CXL treatment and at 12 months postoperatively.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years of age or older
- A diagnosis of keratoconus or a diagnosis of corneal ectasia after corneal refractive surgery
- Vision with contact lenses or glasses is worse than 20/20
- Corneal thickness greater than 375 microns at the thinnest point
Exclusion Criteria:
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
- Corneal pachymetry ≤ 350 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
- Clinically significant corneal scarring in the CXL treatment zone
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
- Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464268
United States, New Jersey | |
Cornea and Laser Eye Institute | |
Teaneck, New Jersey, United States, 07666 |
Principal Investigator: | Peter Hersh, MD | Cornea and Laser Eye Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Cornea and Laser Eye Institute |
ClinicalTrials.gov Identifier: | NCT01464268 |
Other Study ID Numbers: |
CLEI-EpiCXL |
First Posted: | November 3, 2011 Key Record Dates |
Last Update Posted: | January 26, 2021 |
Last Verified: | January 2020 |
Keratoconus Corneal Ectasia Collagen Crosslinking Riboflavin |
Keratoconus Corneal Diseases Dilatation, Pathologic Eye Diseases Pathological Conditions, Anatomical Riboflavin Dextrans Vitamin B Complex Vitamins |
Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Photosensitizing Agents Dermatologic Agents Anticoagulants Plasma Substitutes Blood Substitutes |