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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371202
Recruitment Status : Unknown
Verified January 2007 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2006
Last Update Posted : January 15, 2007
Information provided by:
Shahid Beheshti University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Keratoconus Procedure: keratoplasty Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : July 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00371202

Iran, Islamic Republic of
Bahram Einollhi, MD
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Principal Investigator: Bahram Einollahi, MD Ophthalmic Research Center of Shaheed Beheshti Medical University Identifier: NCT00371202     History of Changes
Other Study ID Numbers: 8390
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: January 15, 2007
Last Verified: January 2007

Keywords provided by Shahid Beheshti University of Medical Sciences:
keratoconus, penetrating keratoplasty,
deep lamellar keratoplasty
big bubble technique

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases