| December 11, 2006 |
| December 11, 2006 |
| December 2005 |
| |
- Topography
- Orbscan
- Pachmetry
- Ultrasound Biomicroscopy
- Confocal Microscopy
- Masked Examiner to evaluate transparency and quality of the transplant
|
| Same as current |
| No Changes Posted |
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| |
| |
| Lamellar Transplant With Lyophilized Corneas |
| Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas |
- The goals of this study are to develop a lyophilization method for anterior lamellar transplants in Brasil and to make a comparative analysis among patients transplanted with lyophilized and optisol corneas
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- After the development of a techinique to lyophilize corneas, we randomly assingned 20 patients with keratoconus and visual acuity of < 20/60, who signed the consent term and divided them into 2 groups. One group was transplanted with lyophilized corneas and the other group with optisol corneas.
- Patients are being followed for 6 months with visual acuity, refraction, topography, orbscan, pachmetry, ultrasound biomicroscopy and confocal microscopy.
- Results are going to be statistically analysed by SPSS program.
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| Phase II |
| Interventional |
| Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Keratoconus |
| Procedure: Lamellar transplant with lyophilized corneas |
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| |
| |
| Completed |
| 20 |
| December 2006 |
|
Inclusion Criteria:
- Keratoconus patient
- BCVA < 20/60
- No systemic diseases
- Who signed the inform consent
Exclusion Criteria:
- BCVA > 20/60
- Presence of deep opacities
- Systemic diseases
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Brazil |
| |
| NCT00409955 |
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| CEP 1536/05 |
| Federal University of São Paulo |
- University of Sao Paulo
- Sorocaba Eye Bank
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| Principal Investigator: |
Roberta JM Farias, MD |
Federal University of Sao Paulo |
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| Federal University of São Paulo |
| December 2006 |