Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs

Phase 2

• Conditions: Keratoconus; Ectasia
• Interventions: Drug: Riboflavin

• Registration Number: NCT01081561
• Lead Sponsor: Yaron S. Rabinowitz M.D.

Brief Summary

This study will determine the efficacy of collagen cross linking for progressive keratoconus and ectasia after lasik. It will try and determine which is a more effective treatment: collagen cross linking alone or collagen cross linking combined with Intacs, a treatment which has already been proven to be effective in decreasing corneal curvature in patients with keratoconus.

Detailed Description

In this study we will attempt to determine whether Collagen Cross Linking alone, one combined with insertion of INTACS is the most effective treatment for patients with progressive keratoconus in patients who have progressive disease.

These treatments have been widely used outside of the United States for the treatment of progressive keratoconus. Corneal Collagen Cross linking was recently approved in the United States for the treatment of progressive keratoconus. We will attempt to study 600 patients total. 300 patients will be assigned to cross linking only while another 300 will be assigned to cross linking and INTACS. Once adequate number of study subjects have been recruited data will be analyzed to determine which treatment is more effective. The following parameters from Topography, OCT and Tomography will be studied(these are Max K(pentacam) Kvalue(Tomey Topography)I-Svalue(Tomey Topography Astigmatism(Tomey Topography) and Min OCT(corneal pachymetry) any one of these metrics that achieve a value of 1 or more will be included in the analysis since the cornea is so irregular that values less than one could be artifact

Study Timeline

• Study Start: 2009-01-21
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Status Verified: 2017-12
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-02
• Primary Completion: 2020-12-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• progressive keratoconus or ectasia

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Exclusion Criteria

• cornea thinner than 400um
• K readings greater than 60D
• Central corneal scarring

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cross-linking plus INTACS	Riboflavin	Corneal collagen cross-linking with riboflavin and UVA light plus INTACS
Cross-linking	Riboflavin	Corneal collagen cross-linking with riboflavin and UVA light

Primary Outcome Measures

Name	Time	Method
Effectiveness of UV-X cross linking to halt progression of keratoconus	10 years	Any change of 1 or more of the following indices will be classified as progression. The following parameters will be studied Max K, Steep K, I-S value,Min OCT(pachymetry

Trial Locations

Locations (1)

Cornea Eye Institute, 50 North La Cienaga Blvd, #340; 🇺🇸 Beverly Hills, California, United States