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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

Primary Purpose

Keratoconus

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
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 vertical meridian of recipient cornea
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with KCN who undergo DALK surgery

Exclusion Criteria:

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

Sites / Locations

  • Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

horizontal meridian of donor's cornea sutured to horizontal

horizontal meridian of donor's cornea sutured to vertical

Arm Description

horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea

horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea

Outcomes

Primary Outcome Measures

Best corrected visual acuity
Snellen chart
graft astigmatism
Topography

Secondary Outcome Measures

Full Information

First Posted
October 7, 2019
Last Updated
October 15, 2019
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04130334
Brief Title
Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
horizontal meridian of donor's cornea sutured to horizontal
Arm Type
Active Comparator
Arm Description
horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea
Arm Title
horizontal meridian of donor's cornea sutured to vertical
Arm Type
Active Comparator
Arm Description
horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea
Intervention Type
Procedure
Intervention Name(s)
After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea
Intervention Description
After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea
Intervention Type
Procedure
Intervention Name(s)
: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea
Intervention Description
: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Description
Snellen chart
Time Frame
14 months
Title
graft astigmatism
Description
Topography
Time Frame
14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with KCN who undergo DALK surgery Exclusion Criteria: Penetrating Keratoplasty surgery Other corneal diseases dystrophies Corneal graft rejection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sepehr Feizi, MD
Phone
009822591616
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sepehr Feizi, MD
Phone
009822591616
Email
labbafi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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