NCT05691335

Brief Summary

comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

4.6 years

First QC Date

January 7, 2023

Last Update Submit

March 30, 2023

Conditions

Corneal Ectasia

Outcome Measures

Primary Outcomes (5)

  • Uncorrected distance visual acuity

    measured in logarithm of minimal angle of resolution (logMAR)

    36 months

  • Corrected distance visual acuity

    measured in logarithm of minimal angle of resolution (logMAR)

    36 months

  • Sphere

    measured in diopters (D)

    36 months

  • Cylinder

    measured in diopters (D)

    36 months

  • Keratometry (Kmax)

    measured in diopters (D)

    36 months

Study Arms (3)

Standard CXL

OTHER

Patients treated according to Dresden Protocol with epithelium-off CXL.

Procedure: Standard CXL

Accelerated CXL

EXPERIMENTAL

Patients treated according to accelerated Protocol with epithelium-off CXL.

Procedure: Accelerated CXL

Transepithelial CXL

EXPERIMENTAL

Patients treated according to transepithelial Protocol with epithelium-on CXL.

Procedure: Transepithelial CXL

Interventions

Standard CXLPROCEDURE

Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 30 minutes.

Standard CXL
Accelerated CXLPROCEDURE

Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.

Accelerated CXL
Transepithelial CXLPROCEDURE

Epithelium-on CXL performed by instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.

Transepithelial CXL

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • pediatric patient less than 18 years old
  • keratoconus stage I-III ABCD keratoconus grading system

You may not qualify if:

  • age more than 18 years
  • previous eye surgery
  • current eye infection or pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Sohag, 82425, Egypt

Location

MeSH Terms

Interventions

Corneal Cross-Linking

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Mohammed Iqbal, MD, PhD

    Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2023

First Posted

January 20, 2023

Study Start

June 1, 2018

Primary Completion

January 1, 2023

Study Completion

January 5, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

EG(1)