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

Primary Purpose

Progressive Keratoconus

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
corneal cross-linking
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Keratoconus

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • progressive keratoconus stage 1-2

Exclusion Criteria:

  • any concomitant ocular disease

Sites / Locations

  • Kasr Al Ainy teaching hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transepithelial accelerated cross-linking

Epithelium-off accelerated cross-linking

Arm Description

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

Vibex-rapid is instilled every 2 minutes for 10 minutes followed by ultraviolet-A "UVA" irradiation of 30 mW/cm2 for 4 minutes

Outcomes

Primary Outcome Measures

evaluation of depth of demarcation line
Anterior segment optical coherence tomography "AS-OCT" is used to measure depth of demarcation line

Secondary Outcome Measures

Full Information

First Posted
August 2, 2019
Last Updated
August 3, 2019
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04045626
Brief Title
Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns
Official Title
Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transepithelial accelerated cross-linking
Arm Type
Active Comparator
Arm Description
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
Arm Title
Epithelium-off accelerated cross-linking
Arm Type
Active Comparator
Arm Description
Vibex-rapid is instilled every 2 minutes for 10 minutes followed by ultraviolet-A "UVA" irradiation of 30 mW/cm2 for 4 minutes
Intervention Type
Procedure
Intervention Name(s)
corneal cross-linking
Intervention Description
Riboflavin is instilled over cornea followed by Ultraviolet-A irradiation
Primary Outcome Measure Information:
Title
evaluation of depth of demarcation line
Description
Anterior segment optical coherence tomography "AS-OCT" is used to measure depth of demarcation line
Time Frame
1 month postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: progressive keratoconus stage 1-2 Exclusion Criteria: any concomitant ocular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Azzam, MD
Phone
+201227425601
Email
sarahazzam@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Azzam, MD
Organizational Affiliation
Kasr Al Ainy, cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Al Ainy teaching hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Azzam, MD
Phone
+01227425601
Email
sarahazzam@ymail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31662893
Citation
Salah Y, Omar K, Sherif A, Azzam S. Study of Demarcation Line Depth in Transepithelial versus Epithelium-Off Accelerated Cross-Linking (AXL) in Keratoconus. J Ophthalmol. 2019 Sep 26;2019:3904565. doi: 10.1155/2019/3904565. eCollection 2019.
Results Reference
derived

Learn more about this trial

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

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