Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus - Full Text View

Sponsored by:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00371202

Purpose

it is a randomized clinical trial to compare deep lamellar keratoplasty (DLK) Using big bubble technique and Penetrating Keratoplasty (PK) in patients with keratoconus

Condition	Intervention	Phase
Keratoconus	Procedure: keratoplasty	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	July 2006
Estimated Study Completion Date:	August 2006

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 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.

Eligibility

Ages Eligible for Study:	15 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371202

Locations

Iran, Islamic Republic of
Bahram Einollhi, MD
Tehran, Iran, Islamic Republic of, 16666

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Bahram Einollahi, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

Study ID Numbers:	8390
Study First Received:	August 31, 2006
Last Updated:	January 12, 2007
ClinicalTrials.gov Identifier:	NCT00371202
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

keratoconus, penetrating keratoplasty,
deep lamellar keratoplasty
big bubble technique

Study placed in the following topic categories:

Corneal Diseases
Eye Diseases
Keratoconus

ClinicalTrials.gov processed this record on January 16, 2009