Lamellar Transplant With Lyophilized Corneas

December 11, 2006 updated by: Federal University of São Paulo

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04023-062
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

University of Sao Paulo
Sorocaba Eye Bank

Investigators

  • Principal Investigator: Roberta JM Farias, MD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

December 11, 2006

First Submitted That Met QC Criteria

December 11, 2006

First Posted (Estimate)

December 12, 2006

Study Record Updates

Last Update Posted (Estimate)

December 12, 2006

Last Update Submitted That Met QC Criteria

December 11, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 1536/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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