NCT06549387

Brief Summary

The objective of this study is to compare the clinical effectiveness and safety of Topo-Pachymetric Customized Accelerated Epithelium-On (aCFXL) to Standard Accelerated Epithelium-Off (aCXL) Corneal Collagen Cross-Linking in the management of keratoconus. The study aims to evaluate visual and structural outcomes, to provide valuable insights into optimizing treatment strategies.

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
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 8, 2024

Last Update Submit

August 9, 2024

Conditions

Amount of Corneal Flattening (Kmax Flattening)Change in the Endothelial Cell Count

Outcome Measures

Primary Outcomes (2)

  • Amount of corneal flattening

    Kmax flattening

    6 months

  • Change in the endothelial cell count.

    the stability or decrease in the endothelial cell count.

    6 months

Secondary Outcomes (1)

  • Best corrected visual acuity

    6 months

Study Arms (3)

The topo-pachimetric customized accelerated epithelium-On (aCFXL group)

ACTIVE COMPARATOR
Procedure: Corneal cross linking

The standard accelerated CXL (aCXL) protoco

ACTIVE COMPARATOR
Procedure: Corneal cross linking

Progressive Fluence Epi-on accelerated crosslinking M nomogram

ACTIVE COMPARATOR
Procedure: Corneal cross linking

Interventions

Corneal cross linkingPROCEDURE

Applying UVA irradiation to the cornea after soaking with riboflavin

Progressive Fluence Epi-on accelerated crosslinking M nomogramThe standard accelerated CXL (aCXL) protocoThe topo-pachimetric customized accelerated epithelium-On (aCFXL group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 years or older
  • Corrected distance visual acuity (CDVA) of ≥ 0.3 Snellen.
  • Central corneal thickness (de-epithelialized) of ≥ 400 micron.
  • Corneal endothelial count of ≥ 2000.

You may not qualify if:

  • Previous eye surgery
  • The presence of lesions other than keratoconus, central or paracentral scaring
  • History of Cross linking
  • History of viral keratitis
  • Connective tissue diseases
  • Pregnancy or lactation during the study.
  • The presence of nystagmus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al Ainy

Cairo, Egypt

Location

MeSH Terms

Interventions

Corneal Cross-Linking

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc.

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 12, 2024

Study Start

August 15, 2024

Primary Completion

February 28, 2025

Study Completion

April 30, 2025

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations

EG(1)