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Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04130334
Recruitment Status : Recruiting
First Posted : October 17, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Brief Summary:

Patients with KCN who undergo cornea transplantation divided to 2 groups:

Group1: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea Group 2: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea After suture removal, best corrected visual acuity, refractive error, corneal keratometry, irregularity of corneal surface and high order aberration of two groups will compare


Condition or disease Intervention/treatment Phase
Keratoconus Procedure: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea Procedure: : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN: a Clinical Trial
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : June 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: horizontal meridian of donor's cornea sutured to horizontal
horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea
Procedure: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea
After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea

Active Comparator: horizontal meridian of donor's cornea sutured to vertical
horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea
Procedure: : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea
: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea




Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 14 months ]
    Snellen chart

  2. graft astigmatism [ Time Frame: 14 months ]
    Topography



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with KCN who undergo DALK surgery

Exclusion Criteria:

  • Penetrating Keratoplasty surgery
  • Other corneal diseases
  • dystrophies
  • Corneal graft rejection

Information from the National Library of Medicine

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): NCT04130334


Contacts
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Contact: Sepehr Feizi, MD 009822591616 labbafi@hotmail.com

Locations
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Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Sepehr Feizi, MD    009822591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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Responsible Party: Zahra Rabbani Khah, Head of ophthalmic research center, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04130334    
Other Study ID Numbers: 10000
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases