Comparison of Anwar and Melles Techniques in Deep Anterior Lamellar Keratoplasty (DALK) for Keratoconus Patients
Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00850148
Collaborator
(none)
2
2
16
Study Details
Study Description
Brief Summary
This study will be performed on patients who come to labbafinejad ophthalmic clinic from 20 March 2008. Keratoconus diagnosis will be determined by clinical finding in slit lamp, keratometery and topographic characteristics. Patients will be randomly placed in group A and
- In group A, Anwar surgical method and in B, Melles surgical method, will be done. This is not a blind study due to surgeons' knowledge. All patients will receive Btamethazone drop and Chloramphenicol every 6 hours and will be tapered in two months. In the end anatomical results, complications, BCVA, UCVA, astigmatism, endothelial cell numbers will be compared in two groups by using specular microscopy. Contrast sensivity, central corneal diameter, interface wrinkling and opacity will be measured by metrovison, Confoscan, Photoslit in months 3, 6, 12, respectively and will be evaluated afterwards.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Study Start Date
:
May 1, 2008
Actual Primary Completion Date
:
Jun 1, 2009
Actual Study Completion Date
:
Sep 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Melles
|
Procedure: Melles
Melles surgical method
|
| Experimental: Anwar
|
Procedure: Anwar
Anwar surgical method
|
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
15 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
patients with keratoconus
-
15<age<45
-
contact lens intolerance
Exclusion Criteria:
-
Having a history of any other ophthalmic or systemic problem
-
Central corneal scar
-
descemet's membrane detachment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ophtalmic Research Centre | Tehran | Iran, Islamic Republic of | 1666663111 | |
| 2 | Farid Karimian,MD | Tehran | Iran, Islamic Republic of | 166666 |
Sponsors and Collaborators
- Shahid Beheshti University of Medical Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00850148
Other Study ID Numbers:
- 8721
First Posted:
Feb 24, 2009
Last Update Posted:
Jan 5, 2012
Last Verified:
Feb 1, 2009