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Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Keratitis Corneal Opacity Procedure: PTK with mitomycin in Adenoviral Opacities Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates
Study Start Date : April 2006
Primary Completion Date : May 2008
Estimated Study Completion Date : December 2008

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

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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: August 4, 2008
Last Verified: July 2008

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

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