Lamellar Transplant With Lyophilized Corneas - Tabular View

Tracking Information

First Received Date ^ICMJE

December 11, 2006

Last Updated Date

December 11, 2006

Start Date ^ICMJE

December 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Lamellar Transplant With Lyophilized Corneas

Official Title ^ICMJE

Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Keratoconus

Intervention ^ICMJE

Procedure: Lamellar transplant with lyophilized corneas

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT ID ^ICMJE

NCT00409955

Responsible Party

Study ID Numbers ^ICMJE

CEP 1536/05

Study Sponsor ^ICMJE

Federal University of São Paulo

Collaborators ^ICMJE

University of Sao Paulo
Sorocaba Eye Bank

Investigators ^ICMJE

Principal Investigator:

Roberta JM Farias, MD

Federal University of Sao Paulo

Information Provided By

Federal University of São Paulo

Verification Date

December 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP