Lamellar Transplant With Lyophilized Corneas

Keratoconus Clinical Trial

Official title:

Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409955
• Other study ID #: CEP 1536/05
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2006
• Last updated: December 11, 2006
• Start date: December 2005
• Est. completion date: December 2006

Study information

• Verified date: December 2006
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Lamellar transplant with lyophilized corneas

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	São Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of São Paulo	Sorocaba Eye Bank, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Topography
Primary	Orbscan
Primary	Pachmetry
Primary	Ultrasound Biomicroscopy
Primary	Confocal Microscopy
Primary	Masked Examiner to evaluate transparency and quality of the transplant