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

NCT ID: NCT04130334

Last Updated: 2019-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-03-01

Brief Summary

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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

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Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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horizontal meridian of donor's cornea sutured to horizontal

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with KCN who undergo DALK surgery

Exclusion Criteria

* Penetrating Keratoplasty surgery
* Other corneal diseases
* dystrophies
* Corneal graft rejection
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rabbani Khah

Head of ophthalmic research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ophthalmic Research Center

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Sepehr Feizi, MD

Role: CONTACT

009822591616

Facility Contacts

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Sepehr Feizi, MD

Role: primary

009822591616

Other Identifiers

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10000

Identifier Type: -

Identifier Source: org_study_id

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