NCT04045626

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

August 2, 2019

Last Update Submit

August 3, 2019

Conditions

Progressive Keratoconus

Outcome Measures

Primary Outcomes (1)

  • evaluation of depth of demarcation line

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

    1 month postoperative

Study Arms (2)

Transepithelial accelerated cross-linking

ACTIVE COMPARATOR

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

Epithelium-off accelerated cross-linking

ACTIVE COMPARATOR

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

Interventions

corneal cross-linkingPROCEDURE

Riboflavin is instilled over cornea followed by Ultraviolet-A irradiation

Epithelium-off accelerated cross-linkingTransepithelial accelerated cross-linking

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • progressive keratoconus stage 1-2

You may not qualify if:

  • any concomitant ocular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al Ainy teaching hospital

Cairo, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31662893DERIVED

MeSH Terms

Interventions

Corneal Cross-Linking

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Sarah Azzam, MD

    Kasr El Aini Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Azzam, MD

CONTACT

+201227425601sarahazzam@ymail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 5, 2019

Study Start

August 1, 2019

Primary Completion

January 1, 2020

Study Completion

March 1, 2020

Last Updated

August 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)