- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03903588
The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
New York
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New York, New York, Verenigde Staten, 10036
- State University of New York Optometry School
-
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
Normal
Eyes judged as age-appropriate normal as determined by an Investigator and that meet applicable inclusion/exclusion criteria.
|
Imaging of the Retina
Andere namen:
|
Glaucoma
Eyes that have been diagnoses with Glaucoma
|
Imaging of the Retina
Andere namen:
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Retinal Disease
Eyes that have been diagnoses with a Retinal Disease
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Imaging of the Retina
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Retinal Layer Thickness
Tijdsspanne: 5 months
|
Measurement of the thickness of Retinal layers thickness to assess 2 grids
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5 months
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- S-2018-2
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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