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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04045626
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Sarah Akram Azzam, Kasr El Aini Hospital

Brief Summary:
To assess depth of demarcation line in transepithelial versus epithelium-off accelerated cross-linking in keratoconus patients

Condition or disease Intervention/treatment Phase
Progressive Keratoconus Procedure: corneal cross-linking Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020


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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • progressive keratoconus stage 1-2

Exclusion Criteria:

  • any concomitant ocular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045626


Contacts
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Contact: Sarah Azzam, MD +201227425601 sarahazzam@ymail.com

Locations
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Egypt
Kasr Al Ainy teaching hospital Recruiting
Cairo, Egypt
Contact: Sarah Azzam, MD    +01227425601    sarahazzam@ymail.com   
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: Sarah Azzam, MD Kasr Al Ainy, cairo university
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sarah Akram Azzam, Principal investigator, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT04045626    
Other Study ID Numbers: N28
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases