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

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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Surgery
• Intervention / Treatment: Device: Cross linking

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Accelerated Cross Linking; 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.	Device: Cross linking; Cross linking strategy either standard or accelerated
Active Comparator: Standard Cross linking; 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.	Device: Cross linking; Cross linking strategy either standard or accelerated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
K-max changes	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	12 post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
manifest refractive spherical equivalent (SE) in Diopter power	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	12 months postoperatively

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2016
• Primary Completion (Actual): January 16, 2017
• Study Completion (Actual): June 26, 2017

Study Registration Dates

• First Submitted: December 24, 2018
• First Submitted That Met QC Criteria: December 29, 2018
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: Ophth001/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data used to support the findings of this study are restricted by the Ophthalmic Ethics Committee at Menoufia University Hospital, in order to protect patient privacy. Data are available from Mr Hany Khairy (khairyhany@hotmail.com), for researchers who meet the criteria for access to confidential data.
• IPD Sharing Time Frame: The data used to support the findings of this study are restricted by the Ophthalmic Ethics Committee at Menoufia University Hospital, in order to protect patient privacy. Data are available from Mr Hany Khairy (khairyhany@hotmail.com), for researchers who meet the criteria for access to confidential data after study publcation
• IPD Sharing Access Criteria: Data are available for researchers who meet the criteria for access to confidential data as specified by the Ophthalmic Committee of Menoufia University Hospital
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No