Comparative Study of the Optical Biometer for Measurements of the Eye
26. juni 2013 oppdatert av: Nidek Co. LTD.
Comparative Study of the Optical Biometer for the Measurements of Axial Length, Anterior Chamber Depth, Keratometry, Corneal Cylinder Axis, Corneal Thickness, White-to-White Distance, and Pupil Diameter
The primary purpose of this comparative clinical study is to collect clinical data to demonstrate the equivalence of the investigational device to the predicate device for measurements of the eye.
The secondary purpose is to evaluate any adverse events that occur during the clinical study.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
This is a prospective clinical study to be conducted at a single clinical site located in the United States.
This study will assess the agreement of an investigational device to the predicate device and an ultrasound reference device and the precision of the investigational device with a comparison to the precision of the predicate.
Any adverse events associated with the investigational device can or the predicate device will be assessed.
Studietype
Observasjonsmessig
Registrering (Faktiske)
125
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Greensboro, North Carolina, Forente stater, 27410-2548
- Physicians Protocol
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Normal eyes(phakic eyes without cataracts or corneal disease), eyes with cataracts, eyes without a natural lens (including aphakic and pseudophakic eyes), eyes with corneal disease (including eyes post keratorefractive surgery).
Beskrivelse
Inclusion Criteria:
- Subjects who can follow the instructions by the Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on scheduled examination dates.
- Subjects who sign an informed consent form to participate in the clinical trial.
- Subjects who agree to take the qualifying eye examination and a series of devices measurements.
- Subjects able to fixate on a target.
Subjects must meet at lease one of the following criteria:
- Normal eyes: Subjects with a natural lens without a cataract, corneal abnormalities or prior keratorefractive surgery.
- Eyes with Cataracts: Subjects with a pre-existing cataract without corneal abnormalities or prior keratorefractive surgery.
- Eyes without a Natural Lens: Subjects that are pseudophakic or aphakic without corneal abnormalities or prior keratorefractive surgery.
- Eyes with Corneal Abnormality: Subjects with a corneal abnormality and a natural lens without a cataract, or Subjects post keratorefractive surgery and a natural lens without a cataract.
Exclusion Criteria:
- Pregnancy.
- Any eye condition preventing use of any of the instruments used in the study.
- Any eye condition which might impair the validity of results from any of the instruments used in the study.
- Any medical condition, which, in the Investigator's judgment, interferes with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Agreement Cohort
All subjects in the agreement portion of the study will have a single measurement performed with each device, the Nidek optical biometer, predicate device and ultrasound reference device.
Each device will be operated by a different operator.
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Precision Cohort
All subjects in the precision portion of the study will each be paired with one Nidek optical biometer and with one predicate device for a total of three Nidek optical biometer/predicate device pairs.
Each of the three device pairs will be designated one and only one operator.
All subjects in the precision portion of the study will have their measurements repeated three times on each of three Nidek optical biometer and predicate device pairs.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Agreement and Precision Endpoints Analyses
Tidsramme: Subjects will be followed for the duration of the procedure, up to one day.
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The agreement of the Nidek optical biometer with the predicate device will be assessed for the following measures:
In addition, the agreement of the Nidek optical biometer with the ultrasound reference device will be assessed for axial length and anterior chamber depth. The precision of Nidek optical biometer and the predicate device will be assessed for the following measures:
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Subjects will be followed for the duration of the procedure, up to one day.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Evaluation of Adverse Events Found During the Study
Tidsramme: Subjects will be followed for the duration of the procedure, up to one day.
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The safety endpoint is to evaluate any adverse events associated with the Nidek optical biometer or the predicate or reference devices.
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Subjects will be followed for the duration of the procedure, up to one day.
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Additional Analyses for the Agreement Portion of the Study
Tidsramme: Subjects will be followed for the duration of the procedure, up to one day.
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Additional analyses will examine the intraocular lens (IOL) power calculation from the Nidek optical biometer only based on the subjects enrolled in the agreement portion of the study.
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Subjects will be followed for the duration of the procedure, up to one day.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Karl G Stonecipher, M.D., Physicians Protocol
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2012
Primær fullføring (Faktiske)
1. april 2013
Studiet fullført (Faktiske)
1. mai 2013
Datoer for studieregistrering
Først innsendt
7. november 2012
Først innsendt som oppfylte QC-kriteriene
14. november 2012
Først lagt ut (Anslag)
21. november 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
28. juni 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juni 2013
Sist bekreftet
1. juni 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AL-3
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