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

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.

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Key information

Conditions

Refractive Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Cross linking

Device

Cross linking strategy either standard or accelerated

Primary outcomes

K-max changes

Time frame: 12 post treatment

The main outcomes for comparison were the change in; Maximum-K reading (K-max), Patients were followed up clinically on the first day, first week, one month, 6 months and 12 months postoperatively

Secondary outcomes

manifest refractive spherical equivalent (SE) in Diopter power

Time frame: 12 months postoperatively

The secondary outcomes for comparison were the change in, manifest refractive spherical equivalent (SE).

Patients were followed up clinically on the first day, first week, one month, 6 months and 12 months postoperatively

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Accelerated Versus Standard Corneal Cross Linking in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty: A Long Term Randomized Trial.

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jan 3, 2019
Registry last updated: Jan 4, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed