Lamellar Transplant With Lyophilized Corneas

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00409955
• Collaborator: University of Sao Paulo (Other), Sorocaba Eye Bank (Other)
• Enrollment: 20
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Keratoconus	Procedure: Lamellar transplant with lyophilized corneas	Phase 2

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas
• Study Start Date: Dec 1, 2005
• Study Completion Date: Dec 1, 2006

Outcome Measures

Primary Outcome Measures

1. Topography []

2. Orbscan []

3. Pachmetry []

4. Ultrasound Biomicroscopy []

5. Confocal Microscopy []

6. Masked Examiner to evaluate transparency and quality of the transplant []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal University of Sao Paulo	São Paulo	SP	Brazil	04023-062

Sponsors and Collaborators

• Federal University of São Paulo
• University of Sao Paulo
• Sorocaba Eye Bank

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00409955
• Other Study ID Numbers: CEP 1536/05
• First Posted: Dec 12, 2006
• Last Update Posted: Dec 12, 2006
• Last Verified: Dec 1, 2006

• Keywords provided by , ,: Lamellar transplant; Lyophilization; Corneas storage; Keratoconus patients; Best corrected visual acuity < 20/60; Signed the consent inform
• Additional relevant MeSH terms: Keratoconus

Study Results

No Results Posted as of Dec 12, 2006