Lamellar Transplant With Lyophilized Corneas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-12-31

Brief Summary

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\- 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

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* 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.

Conditions

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Keratoconus

Keywords

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Lamellar transplant Lyophilization Corneas storage Keratoconus patients Best corrected visual acuity < 20/60 Signed the consent inform

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Lamellar transplant with lyophilized corneas

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Roberta JM Farias, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CEP 1536/05

Identifier Type: -

Identifier Source: org_study_id