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T-Cat Laser & Cross-linking for Keratoconus

NCT00777322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2011-07-21

No results posted yet for this study

Summary

The purpose of this study is to determine whether excimer laser corneal surface ablation (T-Cat) can be safely combined with simultaneous corneal collagen cross-linking treatment to produce an improved and stable corneal profile in the treatment of keratoconus.

Conditions

  • Keratoconus
  • Pellucid Marginal Degeneration

Interventions

PROCEDURE

Excimer laser ablation, and collagen cross-linking

Surgery is performed with topical anaesthesia. The central corneal epithelium is removed. Excimer laser ablation is applied (typically 15-30 seconds). Residual bed thickness is checked with an ultrasonic pachymeter. Topical application of riboflavin 0.1% in dextran is commenced at 5 minute intervals. When an adequate saturation of the anterior chamber with riboflavin has been achieved, cross-linking treatment will proceed. Output from the UV light generating equipment is measured with a UV light meter and set at 3mW/cm². Thirty minutes of treatment is given, interrupted at five minute intervals by the application of more topical riboflavin drops. Finally the eye has a bandage soft contact lens placed, with preservative free topical antibiotic, steroid, and cycloplegic drop application.

Sponsors & Collaborators

  • Accuvision Laser Eye Clinics

    collaborator OTHER

  • Carleton Optical Equipment Ltd.

    collaborator INDUSTRY

  • Bon Optics

    collaborator OTHER

  • Sooft Italia

    collaborator INDUSTRY

  • Moorfields Eye Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Chad K Rostron, MB BS · Moorfields Eye Hospital NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United Kingdom

Study Locations

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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 NCT00777322 on ClinicalTrials.gov