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Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
Information provided by:
Federal University of São Paulo Identifier:
First received: June 26, 2007
Last updated: August 1, 2008
Last verified: July 2008
The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.

Condition Intervention
Keratitis Corneal Opacity Procedure: PTK with mitomycin in Adenoviral Opacities

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates

Resource links provided by NLM:

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements. [ Time Frame: one year ]

Secondary Outcome Measures:
  • wavefront analysis, anterior segment tomography data, corneal biomechanics data. [ Time Frame: one year ]

Estimated Enrollment: 30
Study Start Date: April 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00492245

Federal University of Sao Paulo
Sao Paulo, Brazil, 04145020
Sponsors and Collaborators
Federal University of São Paulo
Principal Investigator: Ester S Yamazaki, MD Federal University of Sao Paulo - Brazil
Study Chair: Mauro S Campos, MD Federal University of Sao Paulo - Brazil
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00492245     History of Changes
Other Study ID Numbers: CEP0075/06
Study First Received: June 26, 2007
Last Updated: August 1, 2008

Keywords provided by Federal University of São Paulo:
corneal opacity

Additional relevant MeSH terms:
Corneal Opacity
Corneal Diseases
Eye Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors processed this record on September 21, 2017