Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus
Primary Purpose
Keratoconus
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
keratoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring keratoconus, penetrating keratoplasty,, deep lamellar keratoplasty, big bubble technique
Eligibility 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)
Sites / Locations
- Bahram Einollhi, MD
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00371202
First Posted
August 31, 2006
Last Updated
January 12, 2007
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00371202
Brief Title
Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
keratoconus, penetrating keratoplasty,, deep lamellar keratoplasty, big bubble technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
keratoplasty
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahram Einollahi, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahram Einollhi, MD
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus
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