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Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

Primary Purpose

Keratoconus, Corneal Ectasia

Status

Active

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Riboflavin

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Corneal Ectasia, Collagen Crosslinking, Riboflavin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cornea and Laser Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Riboflavin drops every minute

Riboflavin drops every 2 minutes

Arm Description

Administration of riboflavin every 2 minutes for the duration of UV exposure.

Administration of riboflavin every 1 minute for the duration of UV exposure.

Outcomes

Primary Outcome Measures

Maximum Keratometry

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

Secondary Outcome Measures

Manifest refraction

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

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

Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to CXL treatment and at 12 months postoperatively.

Full Information

NCT ID

NCT01464268

First Posted

November 1, 2011

Last Updated

February 6, 2023

Sponsor

Cornea and Laser Eye Institute

1. Study Identification

Unique Protocol Identification Number

NCT01464268

Brief Title

Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

Official Title

Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 2011 (undefined)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cornea and Laser Eye Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. During previous studies of the CXL procedure, the surface epithelial cells have been removed. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection as no epithelial barrier will be broken, faster visual recovery and improved patient comfort in the early postoperative healing period.

Detailed Description

The objective of this study is to investigate the difference between two regimens of transepithelial crosslinking. The study will compare two riboflavin dosing regimens during the crosslinking procedure. The primary objective of this study is to evaluate the safety and efficacy of transepithelial corneal collagen crosslinking performed with riboflavin 0.1% for reducing corneal curvature. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, we will compare the two groups with regard to their efficacy in reducing corneal curvature. Secondary outcomes will include visual acuity. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, slit lamp examination of the cornea and lens, and contact lens tolerance for contact lens wearers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratoconus, Corneal Ectasia

Keywords

Keratoconus, Corneal Ectasia, Collagen Crosslinking, Riboflavin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Riboflavin drops every minute

Arm Type

Active Comparator

Arm Description

Administration of riboflavin every 2 minutes for the duration of UV exposure.

Arm Title

Riboflavin drops every 2 minutes

Arm Type

Active Comparator

Arm Description

Administration of riboflavin every 1 minute for the duration of UV exposure.

Intervention Type

Drug

Intervention Name(s)

Riboflavin

Other Intervention Name(s)

Riboflavin without dextran

Intervention Description

Administration of riboflavin every 2 minutes for the duration of UV exposure.

Intervention Type

Drug

Intervention Name(s)

Riboflavin

Other Intervention Name(s)

Riboflavin without Dextran

Intervention Description

Administration of riboflavin every 1 minute for the duration of UV exposure.

Primary Outcome Measure Information:

Title

Maximum Keratometry

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Manifest refraction

Description

Time Frame

12 months

Title

Visual Acuity

Description

Time Frame

12 months

Title

Endothelial cell density

Description

Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to CXL treatment and at 12 months postoperatively.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Hersh, MD

Organizational Affiliation

Cornea and Laser Eye Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cornea and Laser Eye Institute

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21183110

Citation

Hersh PS, Greenstein SA, Fry KL. Corneal collagen crosslinking for keratoconus and corneal ectasia: One-year results. J Cataract Refract Surg. 2011 Jan;37(1):149-60. doi: 10.1016/j.jcrs.2010.07.030.

Results Reference

background

PubMed Identifier

32557558

Citation

Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.

Results Reference

derived

Learn more about this trial

Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

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