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

Phase 2

• Conditions: Keratoconus

• Registration Number: NCT04130334
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Status Verified: 2019-05
• Primary Completion: 2019-06-01
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-15
• Last Update Submitted: 2019-10-15
• Study First Posted: 2019-10-17
• Last Update Posted: 2019-10-17
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Patients with KCN who undergo DALK surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity	14 months	Snellen chart
graft astigmatism	14 months	Topography

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of