Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409955
Status:
COMPLETED
Last Update Posted:
2006-12-12
First Post:
2006-12-11
Brief Title:
Lamellar Transplant With Lyophilized Corneas
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2060 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None