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

Keratoconus Clinical Trial

Official title:

Randomized Study of Corneal Collagen Cross-Linking With the UV-X System for the Treatment of Keratectasia in Eyes With Intacs Compared to Eyes Without Intacs

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01081561
• Other study ID #: #20090780
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: January 21, 2009
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2017
• Source: Cornea Genetic Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: June 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• progressive keratoconus or ectasia

Exclusion Criteria:

• cornea thinner than 400um

• K readings greater than 60D

• Central corneal scarring

Related Conditions & MeSH terms

• Ectasia
• Keratoconus

Intervention

Drug:
• Riboflavin
Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.

Locations

Country	Name	City	State
United States	Cornea Eye Institute, 50 North La Cienaga Blvd, #340	Beverly Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Yaron S. Rabinowitz M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of UV-X cross linking to halt progression of keratoconus	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	10 years