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

NCT01081561 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2018-10-02

No results posted yet for this study

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.

Conditions

  • Keratoconus
  • Ectasia

Interventions

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.

Sponsors & Collaborators

  • Yaron S. Rabinowitz M.D.

    lead OTHER

Principal Investigators

  • Yaron S Rabinowitz, M.D. · Cornea Genetic Eye Institute

  • Ezra Maguen, M.D. · american eye institute

  • Yuri Oleynikov, M.D. PhD · Cornea Genetic Eye Institute

  • James Salz, M.D. · Laser Eye Associates

  • Ronald Gaster, MD · Cornea Eye Institute, Beverly Hills

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-21
Primary Completion
2020-12-30
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01081561 on ClinicalTrials.gov