Status:
SUSPENDED
Repeatability, Reproducibility and Comparison of Cirrus OCT, RTVue OCT, MS-39 OCT, and Insight 100 VHFDU
Lead Sponsor:
London Vision Clinic
Collaborating Sponsors:
Carl Zeiss Meditec AG
Conditions:
Corneal Thickness Measurement
Epithelial Thickness Measurement
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the repeatability and reproducibility of corneal, epithelial, and LASIK flap thickness using the Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO ...
Detailed Description
Very high-frequency (VHF) digital ultrasound was first used in 1993 to obtain images and measure the thickness of the cornea (the window at the front of the eye) and the layers within the cornea, such...
Eligibility Criteria
Inclusion
- Only patients who are medically suitable for corneal laser refractive surgery can be included in the study.
- As general inclusion criteria the following aspects are defined:
- Subjects should be 21 years of age or older.
- Contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses.
- Patient will be able to understand the patient information and willing to sign an informed consent.
- For the normal eye populations:
- Eyes with no ocular pathology
- Eyes with no previous ocular or corneal surgery
- For the post-op eye populations:
- • Eyes between 3 and 9 months after LASIK or SMILE
Exclusion
- Previous ocular or corneal surgery (for normal eyes)
- Patient not being able to tolerate local or topical anesthesia
- Patient has active conjunctivitis or any active ocular infection or inflammation
- Patient has a corneal ulcer
- Patient has an open wound on the corneal epithelium
- Patient has compromised epithelium (e.g. ≥Grade 3 superficial punctate keratitis)
- Pregnancy
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT03473847
Start Date
September 1 2022
End Date
December 1 2023
Last Update
April 26 2022
Active Locations (1)
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1
London Vision Clinic
London, United Kingdom, W1G 7LA