Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities
Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates
1 other identifier
interventional
30
1 country
1
Brief Summary
The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 26, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedAugust 4, 2008
July 1, 2008
2.1 years
June 26, 2007
August 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements.
one year
Secondary Outcomes (1)
wavefront analysis, anterior segment tomography data, corneal biomechanics data.
one year
Interventions
Eligibility Criteria
You may qualify if:
- visual acuity worse than 20/40, caused by central subepithelial fibrosis
You may not qualify if:
- pregnancy, age less than 18 years-old or more than 80 years-old.
- diabetes, autoimmune diseases, corneal thickness less tha 400 micron.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Sao Paulo
São Paulo, São Paulo, 04145020, Brazil
Related Publications (4)
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.
PMID: 12631015BACKGROUNDPorges 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.
PMID: 12553604BACKGROUNDKhurana 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.
PMID: 17307254BACKGROUNDYamazaki 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.
PMID: 21109229DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ester S Yamazaki, MD
Federal University of Sao Paulo - Brazil
- STUDY CHAIR
Mauro S Campos, MD
Federal University of Sao Paulo - Brazil
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 26, 2007
First Posted
June 27, 2007
Study Start
April 1, 2006
Primary Completion
May 1, 2008
Study Completion
December 1, 2008
Last Updated
August 4, 2008
Record last verified: 2008-07