search
Back to results

Comparison of Anwar and Melles Techniques in Deep Anterior Lamellar Keratoplasty (DALK) for Keratoconus Patients

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Anwar
Melles
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Keratoconus focused on measuring Anwar, Melles, Keratoconus

Eligibility Criteria

15 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ophtalmic Research Centre
  • Farid Karimian,MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Melles

Anwar

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 23, 2009
Last Updated
January 4, 2012
Sponsor
Shahid Beheshti University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT00850148
Brief Title
Comparison of Anwar and Melles Techniques in Deep Anterior Lamellar Keratoplasty (DALK) for Keratoconus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. 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 B. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Anwar, Melles, Keratoconus

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
Melles
Arm Type
Experimental
Arm Title
Anwar
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Anwar
Intervention Description
Anwar surgical method
Intervention Type
Procedure
Intervention Name(s)
Melles
Intervention Description
Melles surgical method

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ophtalmic Research Centre
City
Tehran
ZIP/Postal Code
1666663111
Country
Iran, Islamic Republic of
Facility Name
Farid Karimian,MD
City
Tehran
ZIP/Postal Code
166666
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Comparison of Anwar and Melles Techniques in Deep Anterior Lamellar Keratoplasty (DALK) for Keratoconus Patients

We'll reach out to this number within 24 hrs