Clinical Trials Directory

Trials / Completed

CompletedNCT03791684

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
111 (actual)
Sponsor
Menoufia University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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).

Conditions

Interventions

TypeNameDescription
DEVICECross linkingCross linking strategy either standard or accelerated

Timeline

Start date
2016-01-16
Primary completion
2017-01-16
Completion
2017-06-26
First posted
2019-01-03
Last updated
2019-01-04

Source: ClinicalTrials.gov record NCT03791684. Inclusion in this directory is not an endorsement.