Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

NCT ID: NCT05691335

Last Updated: 2023-03-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2023-01-05

Brief Summary

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

Detailed Description

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comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking for treatment of documented pediatric keratoconus progression. The study patients are divided into 3 groups. Group A patient treated with standard cross-linking. Group B patients treated with accelerated cross-linking. Group C patients treated with transepithelial cross-linking.

Conditions

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Corneal Ectasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard CXL

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

Group Type OTHER

Standard CXL

Intervention Type PROCEDURE

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

Accelerated CXL

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

Group Type EXPERIMENTAL

Accelerated CXL

Intervention Type PROCEDURE

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

Transepithelial CXL

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

Group Type EXPERIMENTAL

Transepithelial CXL

Intervention Type PROCEDURE

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

Interventions

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Standard CXL

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

Intervention Type PROCEDURE

Accelerated CXL

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

Intervention Type PROCEDURE

Transepithelial CXL

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* age more than 18 years
* previous eye surgery
* current eye infection or pathology
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Mohammed Iqbal

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed Iqbal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

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Faculty of medicine

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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10-4/2018

Identifier Type: -

Identifier Source: org_study_id

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