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

Refractive Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03791684
• Other study ID #: Ophth001/2016
• Status: Completed
• Phase: N/A
• Start date: January 16, 2016
• Est. completion date: June 26, 2017

Study information

• Verified date: January 2019
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 26, 2017
• Est. primary completion date: January 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Surgery

Intervention

Device:
• Cross linking
Cross linking strategy either standard or accelerated

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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