Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

Analysis of the Outcomes of Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05691335

Enrollment

Registered

2023-01-20

Start date

2018-06-01

Completion date

2023-01-05

Last updated

2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Ectasia

Brief summary

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

Detailed description

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.

Interventions

PROCEDUREStandard CXL

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

PROCEDUREAccelerated CXL

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

PROCEDURETransepithelial CXL

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Uncorrected distance visual acuity	36 months	measured in logarithm of minimal angle of resolution (logMAR)
Corrected distance visual acuity	36 months	measured in logarithm of minimal angle of resolution (logMAR)
Sphere	36 months	measured in diopters (D)
Cylinder	36 months	measured in diopters (D)
Keratometry (Kmax)	36 months	measured in diopters (D)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026