Status:
COMPLETED
Spectralis OCT Repeatability and Reproducibility Study
Lead Sponsor:
Heidelberg Engineering GmbH
Conditions:
Glaucoma
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This single-center, prospective, interventional clinical study is conducted to evaluate the repeatability and reproducibility of structural parameters of the optic nerve head, the peripapillary retina...
Detailed Description
The study will include approximately 15 normal subjects and approximately 15 subjects who have glaucoma of varying degree. All subjects will undergo Spectralis OCT imaging and other study procedures i...
Eligibility Criteria
Inclusion
- Subject is not an employee of the eye clinic.
- Age ≥18
- Able and willing to undergo the test procedures, give consent, and to follow instructions.
- For "normal subjects": Healthy eye without prior intraocular surgery (except cataract surgery and Lasik - laser-assisted refractive surgery) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
- For "glaucoma subjects": Early to advanced glaucoma according to existing medical charts.
- Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
- When both eyes are eligible, one randomly selected eye will enter the study.
Exclusion
- • Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:
- Retina completely included in image frame,
- Quality Score ≥ 20 in the stored ART mean images
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02209077
Start Date
June 1 2013
End Date
July 1 2013
Last Update
August 5 2014
Active Locations (1)
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1
Department of Ophthalmology and Visual Sciences, Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2Y9