This trial is active, not recruiting.

Condition keratoconus
Treatment keratoplasty
Phase phase 3
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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

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
time frame:

Eligibility Criteria

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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2007.
Information provided to ClinicalTrials.gov by Shahid Beheshti Medical University.