- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03903588
The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10036
- State University of New York Optometry School
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Normal
Eyes judged as age-appropriate normal as determined by an Investigator and that meet applicable inclusion/exclusion criteria.
|
Imaging of the Retina
Andre navne:
|
Glaucoma
Eyes that have been diagnoses with Glaucoma
|
Imaging of the Retina
Andre navne:
|
Retinal Disease
Eyes that have been diagnoses with a Retinal Disease
|
Imaging of the Retina
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Retinal Layer Thickness
Tidsramme: 5 months
|
Measurement of the thickness of Retinal layers thickness to assess 2 grids
|
5 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- S-2018-2
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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