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NCT00492245 Clinical Trial

Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

Keratitis Clinical Trial

Official title:
Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00492245
Other study ID # CEP0075/06
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 26, 2007
Last updated August 1, 2008
Start date April 2006
Est. completion date December 2008

Study information
Verified date July 2008
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date December 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• PTK with mitomycin in Adenoviral Opacities

Locations
Country Name City State
Brazil Federal University of Sao Paulo Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Fagerholm P. Phototherapeutic keratectomy: 12 years of experience. Acta Ophthalmol Scand. 2003 Feb;81(1):19-32. Review. — View 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. Epub 2007 Feb 20. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements. one year
Secondary wavefront analysis, anterior segment tomography data, corneal biomechanics data. one year
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