Lamellar Transplant With Lyophilized Corneas - Full Text View

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

ChemIDplus related topics:

Oprelvekin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas

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, SP
	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

Study ID Numbers:	CEP 1536/05
First Received:	December 11, 2006
Last Updated:	December 11, 2006
ClinicalTrials.gov Identifier:	NCT00409955
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

Study placed in the following topic categories:

Corneal Diseases

Oprelvekin

Eye Diseases

Keratoconus

ClinicalTrials.gov processed this record on August 20, 2008

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