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Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00492245
First received: June 26, 2007
Last updated: August 1, 2008
Last verified: July 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates

Resource links provided by NLM:

Drug Information available for: Mitomycin
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492245

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, Brazil, 04145020
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00492245     History of Changes
Other Study ID Numbers: CEP0075/06
Study First Received: June 26, 2007
Last Updated: August 1, 2008
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
PTK
corneal opacity
mitomycin

Additional relevant MeSH terms:
Corneal Opacity
Keratitis
Corneal Diseases
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on May 21, 2013