Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

Not Applicable

• Conditions: Keratitis; Corneal Opacity

• Registration Number: NCT00492245
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.

Detailed Description

Epidemic keratoconjunctivitis is a very common disease, some patients developed a complication after the infection wich is corneal infiltration. Topical treatment sometimes helps to avoid loss of visual acuity. Therefore recurrence of the opacities after topical drops is observed. When corneal fibrosis occur is difficult to achieve visual rehabilitation with topical approach. This study evaluate pre and postoperative data of patients with subepithelial fibrosis caused by adenoviral infiltrates submitted to phototherapeutic keratectomy (PTK) using mitomycin C.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Primary Completion: 2008-05
• Status Verified: 2008-07
• Last Update Submitted: 2008-08-01
• Last Update Posted: 2008-08-04
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• visual acuity worse than 20/40, caused by central subepithelial fibrosis

Exclusion Criteria

• pregnancy, age less than 18 years-old or more than 80 years-old.
• diabetes, autoimmune diseases, corneal thickness less tha 400 micron.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements.	one year

Secondary Outcome Measures

Name	Time	Method
wavefront analysis, anterior segment tomography data, corneal biomechanics data.	one year

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil