Topo-Pachymetric Customized Accelerated Epi-On Vs Accelerated Epi-Off Corneal Cross Linking in Keratoconus Management

NCT ID: NCT06549387

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type ACTIVE_COMPARATOR

Corneal cross linking

Intervention Type PROCEDURE

Applying UVA irradiation to the cornea after soaking with riboflavin

The standard accelerated CXL (aCXL) protoco

Group Type ACTIVE_COMPARATOR

Corneal cross linking

Intervention Type PROCEDURE

Applying UVA irradiation to the cornea after soaking with riboflavin

Progressive Fluence Epi-on accelerated crosslinking M nomogram

Group Type ACTIVE_COMPARATOR

Corneal cross linking

Intervention Type PROCEDURE

Applying UVA irradiation to the cornea after soaking with riboflavin

Interventions

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Corneal cross linking

Applying UVA irradiation to the cornea after soaking with riboflavin

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Previous eye surgery
2. The presence of lesions other than keratoconus, central or paracentral scaring
3. History of Cross linking
4. History of viral keratitis
5. Connective tissue diseases
6. Pregnancy or lactation during the study.
7. The presence of nystagmus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Paula Sameh Youssef

M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr Al Ainy

Cairo, , Egypt

Site Status

Countries

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Egypt

Facility Contacts

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Paula Sameh Youssef, M.Sc.

Role: primary

01286725750

Other Identifiers

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_MD-402-2023_

Identifier Type: -

Identifier Source: org_study_id

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