Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00492245
Recruitment Status : Unknown
Verified July 2008 by Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2007
Last Update Posted : August 4, 2008
Information provided by:
Federal University of São Paulo

June 26, 2007
June 27, 2007
August 4, 2008
April 2006
May 2008   (Final data collection date for primary outcome measure)
Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements. [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT00492245 on Archive Site
wavefront analysis, anterior segment tomography data, corneal biomechanics data. [ Time Frame: one year ]
Same as current
Not Provided
Not Provided
Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities
Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates
The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.
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.
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Keratitis
  • Corneal Opacity
Procedure: PTK with mitomycin in Adenoviral Opacities
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2008
May 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Federal University of São Paulo
Not Provided
Principal Investigator: Ester S Yamazaki, MD Federal University of Sao Paulo - Brazil
Study Chair: Mauro S Campos, MD Federal University of Sao Paulo - Brazil
Federal University of São Paulo
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP