Keratitis Clinical Trial
Official title:
Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates
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 |
The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
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
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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