Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

• Sponsor: Sohag University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05691335
• Collaborator: (none)
• Enrollment: 97
• Location: 1
• Arms: 3
• Actual Duration (Months): 55.2
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Corneal Ectasia	Procedure: Standard CXL; Procedure: Accelerated CXL; Procedure: Transepithelial CXL	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Analysis of the Outcomes of Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Jan 1, 2023
• Actual Study Completion Date: Jan 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard CXL Patients treated according to Dresden Protocol with epithelium-off CXL.	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.
Experimental: Accelerated CXL Patients treated according to accelerated Protocol with epithelium-off CXL.	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.
Experimental: Transepithelial CXL Patients treated according to transepithelial Protocol with epithelium-on CXL.	Procedure: Transepithelial CXL; Epithelium-on CXL performed by instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.

Outcome Measures

Primary Outcome Measures

1. Uncorrected distance visual acuity [36 months]

   measured in logarithm of minimal angle of resolution (logMAR)

2. Corrected distance visual acuity [36 months]

   measured in logarithm of minimal angle of resolution (logMAR)

3. Sphere [36 months]

   measured in diopters (D)

4. Cylinder [36 months]

   measured in diopters (D)

5. Keratometry (Kmax) [36 months]

   measured in diopters (D)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine	Sohag		Egypt	82425

Sponsors and Collaborators

• Sohag University

Investigators

• Principal Investigator: Mohammed Iqbal, MD, PhD, Sohag University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Mohammed Iqbal, Professor, Sohag University
• ClinicalTrials.gov Identifier: NCT05691335
• Other Study ID Numbers: 10-4/2018
• First Posted: Jan 20, 2023
• Last Update Posted: Jan 25, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Keratoconus

Study Results

No Results Posted as of Jan 25, 2023