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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 22, 2014