This trial is active, not recruiting.

Conditions keratitis, corneal opacity
Treatment ptk with mitomycin in adenoviral opacities
Sponsor Federal University of São Paulo
Start date April 2006
End date May 2008
Trial size 30 participants
Trial identifier NCT00492245, CEP0075/06


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements.
time frame: one year

Secondary Outcomes

wavefront analysis, anterior segment tomography data, corneal biomechanics data.
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates
Principal investigator Ester S Yamazaki, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2008.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.