Topo-Pachymetric Customized Accelerated Epi-On Vs Accelerated Epi-Off Corneal Cross Linking in Keratoconus Management

August 9, 2024 updated by: Paula Sameh Youssef, Kasr El Aini Hospital

Topo-Pachymetric Customized Accelerated Epithelium-On Versus Standard Accelerated Epithelium-Off Corneal Collagen Cross Linking in the Management of Keratoconus

The objective of this study is to compare the clinical effectiveness and safety of Topo-Pachymetric Customized Accelerated Epithelium-On (aCFXL) to Standard Accelerated Epithelium-Off (aCXL) Corneal Collagen Cross-Linking in the management of keratoconus. The study aims to evaluate visual and structural outcomes, to provide valuable insights into optimizing treatment strategies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age: 18 years or older
  2. Corrected distance visual acuity (CDVA) of ≥ 0.3 Snellen.
  3. Central corneal thickness (de-epithelialized) of ≥ 400 micron.
  4. Corneal endothelial count of ≥ 2000.

Exclusion Criteria:

  1. Previous eye surgery
  2. The presence of lesions other than keratoconus, central or paracentral scaring
  3. History of Cross linking
  4. History of viral keratitis
  5. Connective tissue diseases
  6. Pregnancy or lactation during the study.
  7. The presence of nystagmus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The topo-pachimetric customized accelerated epithelium-On (aCFXL group)
Procedure: Corneal cross linking
Applying UVA irradiation to the cornea after soaking with riboflavin
Active Comparator: The standard accelerated CXL (aCXL) protoco
Procedure: Corneal cross linking
Applying UVA irradiation to the cornea after soaking with riboflavin
Active Comparator: Progressive Fluence Epi-on accelerated crosslinking M nomogram
Procedure: Corneal cross linking
Applying UVA irradiation to the cornea after soaking with riboflavin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of corneal flattening
Time Frame: 6 months
Kmax flattening
6 months
Change in the endothelial cell count.
Time Frame: 6 months
the stability or decrease in the endothelial cell count.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Best corrected visual acuity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • _MD-402-2023_

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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