Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371202
Status:
UNKNOWN
Last Update Posted:
2007-01-15
First Post:
2006-08-31
Brief Title:
Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus
Sponsor:
Shahid Beheshti University of Medical Sciences
Organization:
Shahid Beheshti University of Medical Sciences
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
it is a randomized clinical trial to compare deep lamellar keratoplasty DLK Using big bubble technique and Penetrating Keratoplasty PK in patients with keratoconus
Detailed Description:
In this randomized clinical trial 50 keratoconic eyes of 50 patients randomly assigned in two groups 25 patients underwent DLK with the big bubble technique and the other 25 patients underwent PK with the standard technique using hessburg - Barron trephine One surgeon performed all operations using a 16 bites separate 10-0 nylon sutures We used A-scan ultrasonic biometry for measuring vitreous length VL before surgery If VL1550mm a trephine 025mm larger than recipient and if VL was 1550mm a trephine 050 mm larger than recipient were considered Selective suture removal was started 3 months after operation quality of vision endothelial cell changes and correlation between refractive outcome and VL in relation to donor-recipient disparity were measured and analyzed in both PK and DLK 15 mos postoperatively
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