Accelerated Versus Standard CXL in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty.

M

Menoufia University

Status

Completed

Conditions

Refractive Surgery

Treatments

Device: Cross linking

Study type

Interventional

Funder types

Other

Identifiers

NCT03791684
Ophth001/2016

Details and patient eligibility

About

WHAT WAS KNOWN *Standard CXL is the common procedure for treating progressive corneal ectasia. Modifications of the standard protocol were introduces to reduce its complications especially long exposure to ultraviolet rays. The Accelerated protocol, while believed to overcome this issue with comparable outcomes, has not been studied fully in patients with ectasia following corneal refractive surgery and penetrating keratoplasty. WHAT THIS PAPER ADDS Accelerated CXL is as safe and effective as the Standard CXL in halting the progression of ectasia post refractive surgery and penetrating keratoplasty with the benefit of: reduced ultraviolet exposure, reduced operation time, and reduced patient discomfort.

Full description

Purpose: The aim of this study is to compare the clinical outcomes of the Standard CXL and the AC CXL in patients with progressive corneal ectasia post refractive surgery and penetrating keratoplasty. Setting: Menoufia University Hospital, Egypt Design: Prospective, randomised comparison. Methods: Patients scheduled to receive either Standard CXL (3mW/cm2 for a period of 30 min) or Accelerated CXL (18mW/cm2 for a period of 5 min).The main outcomes for comparison were the change in; Maximum-K reading (K-max), manifest refractive spherical equivalent (SE), central corneal thickness (CCT), and the best corrected distance visual acuity (CDVA).

Enrollment

111 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Eligible patients were:

  • adults aged above 18 years.
  • They have been diagnosed clinically with progressive corneal ectasia following refractive surgery procedure (LASIK, PRK, ReLex smile), or penetrating keratoplasty
  • CCT above 400µ.

Exclusion criteria

The exclusion criteria involved:

  • history of herpetic ocular diseases (including herpes simplex virus and varicella zoster virus) in the study eye
  • active or recurrent ocular disease in either eye (e.g., uveitis, chronic moderate to severe blepharitis or severe dry eye) or sight-threatening diseases (e.g., previous retinal or optic nerve diseases) that would interfere with the interpretation of the study data.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

111 participants in 2 patient groups

Accelerated Cross Linking
Active Comparator group
Description:
Ultraviolet A radiation of 365 nm wavelength (CCL-365 vario, Peschke Meditrade GmbH, Switzerland), and an irradiance of 18mW/cm2 (spot size 7mm), at a distance of 45 mm from the cornea, was applied for a period of 5 min, delivering a dose of 5.4 J/cm2.
Treatment:
Device: Cross linking
Standard Cross linking
Active Comparator group
Description:
Ultraviolet A radiation of 365 nm wavelength (CCL-365 vario, Peschke Meditrade GmbH, Switzerland), and an irradiance of 3mW/cm2 (spot size 7mm), at a distance of 45 mm from the cornea, was applied for a period of 30 min, delivering a dose of 5.4 J/cm2.
Treatment:
Device: Cross linking

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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