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

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Keratoconus

Treatments: Procedure: : After mechanical trephination, 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 horizontal meridian of recipient cornea

Study type: Interventional

Funder types: Other

Identifiers

NCT04130334

10000 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 52 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with KCN who undergo DALK surgery

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

horizontal meridian of donor's cornea sutured to horizontal

Active Comparator group

Description:

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

Treatment:

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

horizontal meridian of donor's cornea sutured to vertical

Active Comparator group

Description:

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

Treatment:

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