Accelerated Versus Standard CXL in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Eligible patients were:
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adults aged above 18 years.
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They have been diagnosed clinically with progressive corneal ectasia following refractive surgery procedure (LASIK, PRK, ReLex smile), or penetrating keratoplasty
-
CCT above 400ยต.
Exclusion Criteria:
-
The exclusion criteria involved:
-
history of herpetic ocular diseases (including herpes simplex virus and varicella zoster virus) in the study eye
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Menoufia University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Ophth001/2016