Back to resultsAccelerated Versus Standard CXL in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty.
Primary Purpose
Refractive Surgery
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cross linking
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Surgery
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Accelerated Cross Linking
Standard Cross linking
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03791684
Brief Title
Accelerated Versus Standard CXL in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty.
Official Title
Accelerated Versus Standard Corneal Cross Linking in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty: A Long Term Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2016 (Actual)
Primary Completion Date
January 16, 2017 (Actual)
Study Completion Date
June 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Accelerated Cross Linking
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Cross linking
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cross linking
Intervention Description
Cross linking strategy either standard or accelerated
Primary Outcome Measure Information:
Title
K-max changes
Description
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
Time Frame
12 post treatment
Secondary Outcome Measure Information:
Title
manifest refractive spherical equivalent (SE) in Diopter power
Description
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
Time Frame
12 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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
IPD Sharing 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
Learn more about this trial
Accelerated Versus Standard CXL in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty.
We'll reach out to this number within 24 hrs