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

Primary Purpose

Keratoconus, Ectasia

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Riboflavin

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

progressive keratoconus or ectasia

Exclusion Criteria:

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

Sites / Locations

Cornea Eye Institute, 50 North La Cienaga Blvd, #340

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Cross-linking

Cross-linking plus INTACS

Arm Description

Corneal collagen cross-linking with riboflavin and UVA light

Corneal collagen cross-linking with riboflavin and UVA light plus INTACS

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01081561

First Posted

March 4, 2010

Last Updated

October 1, 2018

Sponsor

Yaron S. Rabinowitz M.D.

1. Study Identification

Unique Protocol Identification Number

NCT01081561

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 21, 2009 (Actual)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yaron S. Rabinowitz M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

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

Keratoconus, Ectasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cross-linking

Arm Type

Active Comparator

Arm Description

Corneal collagen cross-linking with riboflavin and UVA light

Arm Title

Cross-linking plus INTACS

Arm Type

Active Comparator

Arm Description

Corneal collagen cross-linking with riboflavin and UVA light plus INTACS

Intervention Type

Drug

Intervention Name(s)

Riboflavin

Other Intervention Name(s)

Peschke Meditrade

Intervention Description

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.

Primary Outcome Measure Information:

Title

Effectiveness of UV-X cross linking to halt progression of keratoconus

Description

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

Time Frame

10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: progressive keratoconus or ectasia Exclusion Criteria: cornea thinner than 400um K readings greater than 60D Central corneal scarring

Overall Study Officials: