Lamellar Transplant With Lyophilized Corneas

Federal University of São Paulo

Status and phase: Completed; Phase 2

Conditions: Keratoconus

Treatments: Procedure: Lamellar transplant with lyophilized corneas

Study type: Interventional

Funder types: Other

Identifiers

NCT00409955

CEP 1536/05

Details and patient eligibility

About

• 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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind