Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus

Keratoconus Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00371202
• Other study ID #: 8390
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 31, 2006
• Last updated: January 12, 2007
• Start date: July 2006
• Est. completion date: August 2006

Study information

• Verified date: January 2007
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• keratoplasty

Locations

Country	Name	City	State
Iran, Islamic Republic of	Bahram Einollhi, MD	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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