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

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ClinicalTrials.gov Identifier: NCT00850148
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : January 5, 2012
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Keratoconus Procedure: Anwar Procedure: Melles Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Study Start Date : May 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Melles Procedure: Melles
Melles surgical method
Experimental: Anwar Procedure: Anwar
Anwar surgical method


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00850148


Locations
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Iran, Islamic Republic of
Ophtalmic Research Centre
Tehran, Iran, Islamic Republic of, 1666663111
Farid Karimian,MD
Tehran, Iran, Islamic Republic of, 166666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
More Information
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ClinicalTrials.gov Identifier: NCT00850148     History of Changes
Other Study ID Numbers: 8721
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: February 2009
Keywords provided by Shahid Beheshti University of Medical Sciences:
Anwar
Melles
Keratoconus
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases