Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus
This trial is active, not recruiting.
|Sponsor||Shahid Beheshti Medical University|
|Start date||July 2006|
|End date||August 2006|
|Trial size||50 participants|
|Trial identifier||NCT00371202, 8390|
it is a randomized clinical trial to compare deep lamellar keratoplasty (DLK) Using big bubble technique and Penetrating Keratoplasty (PK) in patients with keratoconus
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Uncorrected visual acuity (UCVA), best corrected visual acuity(bcva), refractive astigmatism, endothelial cell density, mean cell area, polymegathism (CV), Contrast sensitivity, Root-mean-square (RMS) Wavefront error, Pearson correlation factor between
Male or female participants from 15 years up to 50 years old.
Inclusion Criteria: - moderate to severe keratoconus - contact lens intolerance - low visual acuity due to anterior stromal scar - age between 15 to 50 years Exclusion Criteria: - posterior stromal scar with descemets membrane involvement - history of hydrops - fuchs endothelial dystrophy - glaucoma - cataract - history of intraocular surgery - history of vernal keratoconjunctivitis - intraoperative complications - reoperation (resuturing- regraft)
|Principal investigator||Bahram Einollahi, MD|
|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 VL≥15.50mm, a trephine 0.25mm larger than recipient and if VL was <15.50mm, a trephine 0.50 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.|
Call for more information