Lamellar Transplant With Lyophilized Corneas

Phase 2

Completed

• Conditions: Keratoconus

• Registration Number: NCT00409955
• Lead Sponsor: Federal University of São Paulo

Brief Summary

- 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

Detailed Description

* 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.

Study Timeline

• Study Start: 2005-12
• Status Verified: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2006-12-11
• Study First Submitted QC: 2006-12-11
• Last Update Submitted: 2006-12-11
• Study First Posted: 2006-12-12
• Last Update Posted: 2006-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ultrasound Biomicroscopy
Confocal Microscopy
Topography
Orbscan
Pachmetry
Masked Examiner to evaluate transparency and quality of the transplant

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 São Paulo, SP, Brazil