Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Federal University of São Paulo.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Federal University of São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00492245
First received: June 26, 2007
Last updated: August 1, 2008
Last verified: July 2008
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 26, 2007 | ||||||||
| Last Updated Date | August 1, 2008 | ||||||||
| Start Date ICMJE | April 2006 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements. [ Time Frame: one year ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00492245 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
wavefront analysis, anterior segment tomography data, corneal biomechanics data. [ Time Frame: one year ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities | ||||||||
| Official Title ICMJE | Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates | ||||||||
| 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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | |||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Procedure: PTK with mitomycin in Adenoviral Opacities | ||||||||
| Study Arm (s) | |||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | December 2008 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00492245 | ||||||||
| Other Study ID Numbers ICMJE | CEP0075/06 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | |||||||||
| Study Sponsor ICMJE | Federal University of São Paulo | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Federal University of São Paulo | ||||||||
| Verification Date | July 2008 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
