The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10036
- State University of New York Optometry School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion All Eye Populations
- Age 22 years or older
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- Able to fixate
- Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
- Axial length ≤ 26.0 mm
Exclusion All Eye Populations
- Subjects unable to read or write
- Ocular media is not sufficiently clear to obtain acceptable quality images
- Physical inability to be properly positioned at the study devices or eye exam equipment
Inclusion Normal Population
- Eyes without prior intraocular surgery bilaterally (except cataract surgery and LASIK)
- Intraocular pressure ≤ 21mmHg
- Best corrected visual acuity ≥ 20/40
- Clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape, and clinically normal appearing posterior pole
- Both eyes must be determined to be normal, as determined by an investigator
Exclusion Normal Population
- Subjects with vitreal, retinal or choroidal conditions or disease of the optic nerve. Subjects may have diabetes but cannot have diabetic retinopathy.
- History of glaucoma (not including family history)
- Unreliable visual field as determined by the manufacturer's recommendations of:
Fixation losses > 20%, False Positives > 33%, False Negatives > 15%
-Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings: On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; Glaucoma hemi-field test "outside normal limits"
Inclusion Glaucoma Population
- Subjects who have a glaucoma diagnosis without prior non-glaucoma related intra-ocular surgery (except cataract surgery and LASIK)
- Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
- Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings:
- On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; Glaucoma hemi-field test "outside normal limits."
- Best corrected visual acuity ≥ 20/40
Exclusion Glaucoma Population
- Subjects with presence of any ocular pathology other than Glaucoma in the study eye (cataracts are acceptable)
- Unreliable visual field as determined by the manufacturer's recommendations of:
Fixation losses > 20%, False Positives > 33%, False Negatives > 15%
Inclusion Retina Population
- Subjects who have a retinal condition diagnosis without prior non-retinal related intra-ocular surgery (except cataract surgery and LASIK).
- Intraocular pressure ≤21mmHg
- Best corrected visual acuity ≥20/400
Exclusion Retina Population
-Subjects with presence of any ocular pathology other than retinal conditions in the study eye (cataracts are acceptable)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Normal
Eyes judged as age-appropriate normal as determined by an Investigator and that meet applicable inclusion/exclusion criteria.
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Imaging of the Retina
Other Names:
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Glaucoma
Eyes that have been diagnoses with Glaucoma
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Imaging of the Retina
Other Names:
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Retinal Disease
Eyes that have been diagnoses with a Retinal Disease
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Imaging of the Retina
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retinal Layer Thickness
Time Frame: 5 months
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Measurement of the thickness of Retinal layers thickness to assess 2 grids
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5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S-2018-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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