NCT04130334

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 17, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

October 7, 2019

Last Update Submit

October 15, 2019

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (2)

  • Best corrected visual acuity

    Snellen chart

    14 months

  • graft astigmatism

    Topography

    14 months

Study Arms (2)

horizontal meridian of donor's cornea sutured to horizontal

ACTIVE COMPARATOR

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

horizontal meridian of donor's cornea sutured to vertical

ACTIVE COMPARATOR

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

Interventions

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

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

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

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

horizontal meridian of donor's cornea sutured to vertical

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with KCN who undergo DALK surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Central Study Contacts

Sepehr Feizi, MD

CONTACT

009822591616labbafi@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of ophthalmic research center

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 17, 2019

Study Start

June 1, 2018

Primary Completion

June 1, 2019

Study Completion

March 1, 2020

Last Updated

October 17, 2019

Record last verified: 2019-05

Locations

IR(1)