Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

Sponsor

Federal University of São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT00492245

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2006

Primary Completion Date :

May 1, 2008

Anticipated Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements. [one year]

Secondary Outcome Measures

wavefront analysis, anterior segment tomography data, corneal biomechanics data. [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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