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

• Sponsor: Kasr El Aini Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04045626
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2019
• Anticipated Primary Completion Date: Jan 1, 2020
• Anticipated Study Completion Date: Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. evaluation of depth of demarcation line [1 month postoperative]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• progressive keratoconus stage 1-2

Exclusion Criteria:

• any concomitant ocular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Al Ainy teaching hospital	Cairo		Egypt

Sponsors and Collaborators

• Kasr El Aini Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarah Akram Azzam, Principal investigator, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT04045626
• Other Study ID Numbers: N28
• First Posted: Aug 5, 2019
• Last Update Posted: Aug 6, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Keratoconus

Study Results

No Results Posted as of Aug 6, 2019