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Completed

NCT Number: NCT05691335

Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

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

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Key information

Conditions

Corneal Ectasia

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine

Sohag, 82425, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard CXL

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

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

Procedure

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

Primary outcomes

  1. Uncorrected distance visual acuity

    Time frame: 36 months

    measured in logarithm of minimal angle of resolution (logMAR)

  2. Corrected distance visual acuity

    Time frame: 36 months

    measured in logarithm of minimal angle of resolution (logMAR)

  3. Sphere

    Time frame: 36 months

    measured in diopters (D)

  4. Cylinder

    Time frame: 36 months

    measured in diopters (D)

  5. Keratometry (Kmax)

    Time frame: 36 months

    measured in diopters (D)

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2023
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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