Accelerated Versus Standard CXL in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty.
- Conditions
- Refractive Surgery
- Interventions
- Device: Cross linking
- Registration Number
- NCT03791684
- Lead Sponsor
- Menoufia University
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Accelerated Cross Linking 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. Standard Cross linking 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.
- Primary Outcome Measures
Name Time Method K-max changes 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 Outcome Measures
Name Time Method manifest refractive spherical equivalent (SE) in Diopter power 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