Accelerated Corneal Collagen Crosslinking Protocols

NCT05693740 | Completed

• 1 other identifier: accelerated cross-linking
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate and compare the effect of pulsed light (pl-ACXL) accelerated and continuous light accelerated (cl-ACXL) epithelium-off cross-linking in halting the progression of keratoconus.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (4)

• 1. Visual outcome measures

  Uncorrected and corrected distance visual acuity (UDVA \& CDVA) using Snellen acuity chart

  one year following surgery

• 2. Refractive outcome measures

  Manifest refraction spherical equivalent (MRSE) using Topcon autorefractometer

  one year following surgery

• 3. Topographic outcome measures

  Scheimflug imaging device (Pentacam) for Diagnosis and follow up of Keratoconus after ACXL

  one year following surgery

• Demarcation line depth

  Demarcation line depth is an outcome used to assess the success of CXL procedure using anterior segment ocular coherence tomography (AS-OCT)

  3 months following surgery

Study Arms (2)

group 1

ACTIVE COMPARATOR

Patients in this group will undergo pulsed light accelerated crosslinking (pl-ACXL)

Procedure: Accelerated crosslinking (ACXL)

group 2

ACTIVE COMPARATOR

Patients in this group will undergo continuous-light accelerated crosslinking (cl-ACXL)

Procedure: Accelerated crosslinking (ACXL)

Interventions

Accelerated crosslinking (ACXL) PROCEDURE

Epithelium-off accelerated corneal crosslinking is a procedure in which the cornea is soaked with riboflavin followed by exposure to ultraviolet irradiation in either pulsed-light or continuous-light modes to strengthen the corneal stroma and halt keratoconus progression.

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with mild to moderate progressive keratoconus with maximum keratometry value Kmax \< 56.0 D, Corneal thinnest pachymetry ≥ 400 µm and Corrected distance visual acuity (CDVA) equal to or better than 20/200 Snellen's acuity.
• Established keratoconus progression:
• Increase of 1.0D or more in the manifest cylinder Increase of 0.5D or more in the manifest refraction spherical equivalent Increase of 1.0D or more in Kmax Increase of 0.75D or more in Kmean decrease of 2% or more in central thickness
• Age: 18-40 y
• Clear cornea

You may not qualify if:

• Corneal scarring
• Previous corneal surgery
• Severe keratoconus wit non measurable refraction or Kmax ≥ 56 D or Corneal thinnest pachymetry \< 400 µm

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Tiba eye center

Asyut, 71516, Egypt

Location

Related Publications (1)

• Zhu Y, Reinach PS, Zhu H, Li L, Yang F, Qu J, Chen W. Continuous-light versus pulsed-light accelerated corneal crosslinking with ultraviolet-A and riboflavin. J Cataract Refract Surg. 2018 Mar;44(3):382-389. doi: 10.1016/j.jcrs.2017.12.028.

  PMID: 29703291 BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Mahmoud Abdel-Radi, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor Doctor

Model Details: Single blinded Prospective, Interventional, randomized, comparative study

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: August 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)