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Lamellar Transplant With Lyophilized Corneas

Primary Purpose

Keratoconus

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Lamellar transplant with lyophilized corneas
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Lamellar transplant, Lyophilization, Corneas storage, Keratoconus patients, Best corrected visual acuity < 20/60, Signed the consent inform

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Sao Paulo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 11, 2006
Last Updated
December 11, 2006
Sponsor
Federal University of São Paulo
Collaborators
University of Sao Paulo, Sorocaba Eye Bank
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1. Study Identification

Unique Protocol Identification Number
NCT00409955
Brief Title
Lamellar Transplant With Lyophilized Corneas
Official Title
Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo
Collaborators
University of Sao Paulo, Sorocaba Eye Bank

4. Oversight

5. Study Description

Brief Summary
- 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Lamellar transplant, Lyophilization, Corneas storage, Keratoconus patients, Best corrected visual acuity < 20/60, Signed the consent inform

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Lamellar transplant with lyophilized corneas
Primary Outcome Measure Information:
Title
Topography
Title
Orbscan
Title
Pachmetry
Title
Ultrasound Biomicroscopy
Title
Confocal Microscopy
Title
Masked Examiner to evaluate transparency and quality of the transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta JM Farias, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

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Lamellar Transplant With Lyophilized Corneas

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