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Lamellar Transplant With Lyophilized Corneas

This study has been completed.
Sponsor:
Collaborators:
University of Sao Paulo
Sorocaba Eye Bank
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00409955
First received: December 11, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  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 2

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:

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 May 21, 2013