Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

Sohag University97 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Corneal Ectasia

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.

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.

Transepithelial CXLPROCEDURE

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

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of medicine

Sohag, Egypt

Outcomes

Primary Outcomes

Uncorrected distance visual acuity

measured in logarithm of minimal angle of resolution (logMAR)

Time frame: 36 months

Corrected distance visual acuity

measured in logarithm of minimal angle of resolution (logMAR)

Time frame: 36 months

Sphere

measured in diopters (D)

Time frame: 36 months

Cylinder

measured in diopters (D)

Time frame: 36 months

Keratometry (Kmax)

measured in diopters (D)

Time frame: 36 months

Data from ClinicalTrials.gov

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