NCT05717673

Brief Summary

Determine safety of EPi-off CXL on corneal endothelium by using specular specular microscopy to assess endothelial count.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

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

January 1, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 19, 2023

Last Update Submit

January 29, 2023

Conditions

Keratoconus, Collagen

Outcome Measures

Primary Outcomes (1)

  • Determine safety of CXL on corneal endothelial count by using specular microscopy in patients with keratoconus

    by using specular microscopy to assess endothelial count to prevent corneal damages

    6 months

Interventions

Specular microscopyDEVICE

Specular microscopy is a noninvasive photographic technique that analyze the corneal endothelium. Using computer-assisted morphometry, modern specular microscopes analyze the size, shape and population of the endothelial cells. The instrument projects light onto the cornea and captures the image that is reflected from the optical interface between the corneal endothelium and the aqueous humor. The reflected image is analyzed by the instrument and displayed as a specular photomicrograph

Eligibility Criteria

Age10 Years - 75 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People have keratoconus from 10 years to 75 years has corneal thickness more than 400 um at the thinnest location of the cornea with exclusion criteria like prior herpetic infection or autoimmune disease or corneal opacity

You may qualify if:

  • Patients with corneal diseases that treated by collagen cross linking such as keratokonus and post lasic ectesia with corneal thickness above 400um at its thinnest location.

You may not qualify if:

  • Prior herpetic infection
  • Autoimmune disorders
  • corneal thickness below 400um at its thinnest location
  • Corneal opacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university

Asyut, 088, Egypt

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Mohammed Aly Momen

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Wael MO Soliman, Md

CONTACT

0106 55665302wael.soliman@med.au.edu.eg

Dalia mo elsebati, Md

CONTACT

01223212962drdalia@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Determine safety of CXL on corneal endothelial count by using specular microscopy in patients with keratoconus

Study Record Dates

First Submitted

January 19, 2023

First Posted

February 8, 2023

Study Start

January 1, 2023

Primary Completion

May 5, 2023

Study Completion

August 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-01

Locations

EG(1)