Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

Corneal Ectasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05691335
• Other study ID #: 10-4/2018
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 5, 2023

Study information

• Verified date: March 2023
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: January 5, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Corneal Ectasia
• Keratoconus

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

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