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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04130334
Other study ID # 10000
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 1, 2018
Est. completion date March 1, 2020

Study information

Verified date May 2019
Source Shahid Beheshti University of Medical Sciences
Contact Sepehr Feizi, MD
Phone 009822591616
Email labbafi@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date March 1, 2020
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria:

- Patients with KCN who undergo DALK surgery

Exclusion Criteria:

- Penetrating Keratoplasty surgery

- Other corneal diseases

- dystrophies

- Corneal graft rejection

Study Design


Related Conditions & MeSH terms


Intervention

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
: 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

Locations

Country Name City State
Iran, Islamic Republic of Ophthalmic Research Center Tehran

Sponsors (1)

Lead Sponsor Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Best corrected visual acuity Snellen chart 14 months
Primary graft astigmatism Topography 14 months
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