Lamellar Transplant With Lyophilized Corneas

This study has been completed.

First Received on December 11, 2006. No Changes Posted

Sponsor:	Federal University of São Paulo
Collaborators:	University of Sao Paulo Sorocaba Eye Bank
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00409955

Purpose

- 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

Condition	Intervention	Phase
Keratoconus	Procedure: Lamellar transplant with lyophilized corneas	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas

Resource links provided by NLM:

MedlinePlus related topics: Corneal Disorders

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409955

Locations

Brazil
Federal University of Sao Paulo
São Paulo, SP, Brazil, 04023-062

Sponsors and Collaborators

Federal University of São Paulo

University of Sao Paulo

Sorocaba Eye Bank

Investigators

Principal Investigator:

Roberta JM Farias, MD

Federal University of Sao Paulo

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00409955 History of Changes
Other Study ID Numbers:	CEP 1536/05
Study First Received:	December 11, 2006
Last Updated:	December 11, 2006
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:

Lamellar transplant
Lyophilization
Corneas storage

Keratoconus patients
Best corrected visual acuity < 20/60
Signed the consent inform

Additional relevant MeSH terms:

Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 12, 2012