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Study 11 of 155 for search of: | Iran, Islamic Republic of |
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Sponsored by: |
Shaheed Beheshti Medical University |
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Information provided by: | Shaheed Beheshti Medical University |
ClinicalTrials.gov Identifier: | NCT00371202 |
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 |
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Keratoconus |
Procedure: keratoplasty |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 50 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | August 2006 |
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.
Ages Eligible for Study: | 15 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Iran, Islamic Republic of | |
Bahram Einollhi, MD | |
Tehran, Iran, Islamic Republic of, 16666 |
Principal Investigator: | Bahram Einollahi, MD | Ophthalmic Research Center of Shaheed Beheshti Medical University |
Study ID Numbers: | 8390 |
Study First Received: | August 31, 2006 |
Last Updated: | January 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00371202 |
Health Authority: | Iran: Ethics Committee |
keratoconus, penetrating keratoplasty, deep lamellar keratoplasty big bubble technique |
Corneal Diseases Eye Diseases Keratoconus |