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Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

Primary Purpose

Keratitis, Corneal Opacity

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
PTK with mitomycin in Adenoviral Opacities
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratitis focused on measuring PTK, corneal opacity, mitomycin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of Sao Paulo

Outcomes

Primary Outcome Measures

Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements.

Secondary Outcome Measures

wavefront analysis, anterior segment tomography data, corneal biomechanics data.

Full Information

First Posted
June 26, 2007
Last Updated
August 1, 2008
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00492245
Brief Title
Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities
Official Title
Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2008 (undefined)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis, Corneal Opacity
Keywords
PTK, corneal opacity, mitomycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
PTK with mitomycin in Adenoviral Opacities
Primary Outcome Measure Information:
Title
Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements.
Time Frame
one year
Secondary Outcome Measure Information:
Title
wavefront analysis, anterior segment tomography data, corneal biomechanics data.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester S Yamazaki, MD
Organizational Affiliation
Federal University of Sao Paulo - Brazil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mauro S Campos, MD
Organizational Affiliation
Federal University of Sao Paulo - Brazil
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04145020
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
12631015
Citation
Fagerholm P. Phototherapeutic keratectomy: 12 years of experience. Acta Ophthalmol Scand. 2003 Feb;81(1):19-32. doi: 10.1034/j.1600-0420.2003.00015.x.
Results Reference
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PubMed Identifier
12553604
Citation
Porges Y, Ben-Haim O, Hirsh A, Levinger S. Phototherapeutic keratectomy with mitomycin C for corneal haze following photorefractive keratectomy for myopia. J Refract Surg. 2003 Jan-Feb;19(1):40-3. doi: 10.3928/1081-597X-20030101-08.
Results Reference
background
PubMed Identifier
17307254
Citation
Khurana RN, Li Y, Tang M, Lai MM, Huang D. High-speed optical coherence tomography of corneal opacities. Ophthalmology. 2007 Jul;114(7):1278-85. doi: 10.1016/j.ophtha.2006.10.033. Epub 2007 Feb 20.
Results Reference
background
PubMed Identifier
21109229
Citation
Yamazaki ES, Ferraz CA, Hazarbassanov RM, Allemann N, Campos M. Phototherapeutic keratectomy for the treatment of corneal opacities after epidemic keratoconjunctivitis. Am J Ophthalmol. 2011 Jan;151(1):35-43.e1. doi: 10.1016/j.ajo.2010.07.028. Epub 2010 Nov 24.
Results Reference
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Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

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