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

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04130334
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 2.5

Study Details

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

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

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 1, 2018
• Actual Primary Completion Date: Jun 1, 2019
• Anticipated Study Completion Date: Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Best corrected visual acuity [14 months]

   Snellen chart

2. graft astigmatism [14 months]

   Topography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients with KCN who undergo DALK surgery

Exclusion Criteria:

• Penetrating Keratoplasty surgery

• Other corneal diseases

• dystrophies

• Corneal graft rejection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Research Center	Tehran		Iran, Islamic Republic of

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: 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: Oct 17, 2019
• Last Update Posted: Oct 17, 2019
• Last Verified: May 1, 2019

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

Study Results

No Results Posted as of Oct 17, 2019