Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns

August 3, 2019 updated by: Sarah Akram Azzam, Kasr El Aini Hospital
To assess depth of demarcation line in transepithelial versus epithelium-off accelerated cross-linking in keratoconus patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Anterior segment optical coherence tomography "OCT" will be performed to evaluate the corneal stroma for the presence of demarcation line 1 month postoperatively by an independent observer unware of purpose of study

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Kasr Al Ainy Teaching Hospital
        • Contact:

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • progressive keratoconus stage 1-2

Exclusion Criteria:

  • any concomitant ocular disease

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transepithelial accelerated cross-linking
Paracel is instilled 1 drop every 1.5 minutes for 4.5 minutes then vibex-xtra is instilled 4 drops at 5.5 minutes followed by 1 drop at 6.5 minutes for a total soak time of 11 minutes followed by ultraviolet-A" UVA" irradiation with intended irradiance of 45mW/cm2 for 2.4 minutes
Procedure: corneal cross-linking
Riboflavin is instilled over cornea followed by Ultraviolet-A irradiation
Active Comparator: Epithelium-off accelerated cross-linking
Vibex-rapid is instilled every 2 minutes for 10 minutes followed by ultraviolet-A "UVA" irradiation of 30 mW/cm2 for 4 minutes
Procedure: corneal cross-linking
Riboflavin is instilled over cornea followed by Ultraviolet-A irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of depth of demarcation line
Time Frame: 1 month postoperative
Anterior segment optical coherence tomography "AS-OCT" is used to measure depth of demarcation line
1 month postoperative

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Sarah Azzam, MD, Kasr Al Ainy, cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 1, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 3, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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