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

December 11, 2006
December 11, 2006
December 2005
Not Provided
  • Topography
  • Orbscan
  • Pachmetry
  • Ultrasound Biomicroscopy
  • Confocal Microscopy
  • Masked Examiner to evaluate transparency and quality of the transplant
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Lamellar Transplant With Lyophilized Corneas
Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas

- 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

  • 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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Keratoconus
Procedure: Lamellar transplant with lyophilized corneas
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00409955
CEP 1536/05
Not Provided
Not Provided
Federal University of São Paulo
  • University of Sao Paulo
  • Sorocaba Eye Bank
Principal Investigator: Roberta JM Farias, MD Federal University of Sao Paulo
Federal University of São Paulo
December 2006

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