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

NCT03791684 | Completed

• 1 other identifier: Ophth001/2016
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Refractive Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• manifest refractive spherical equivalent (SE) in Diopter power

  12 months postoperatively

Study Arms (2)

Accelerated Cross Linking

ACTIVE COMPARATOR

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

Standard Cross linking

ACTIVE COMPARATOR

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

Interventions

Cross linking DEVICE

Cross linking strategy either standard or accelerated

Accelerated Cross Linking; Standard Cross linking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Ophthalmology

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: January 3, 2019
• Study Start: January 16, 2016
• Primary Completion: January 16, 2017
• Study Completion: June 26, 2017
• Last Updated: January 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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
• 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