Comparative Study of the Optical Biometer for Measurements of the Eye
26 juni 2013 uppdaterad 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.
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
125
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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North Carolina
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Greensboro, North Carolina, Förenta staterna, 27410-2548
- Physicians Protocol
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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).
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Agreement and Precision Endpoints Analyses
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Evaluation of Adverse Events Found During the Study
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Additional Analyses for the Agreement Portion of the Study
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Karl G Stonecipher, M.D., Physicians Protocol
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2012
Primärt slutförande (Faktisk)
1 april 2013
Avslutad studie (Faktisk)
1 maj 2013
Studieregistreringsdatum
Först inskickad
7 november 2012
Först inskickad som uppfyllde QC-kriterierna
14 november 2012
Första postat (Uppskatta)
21 november 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
28 juni 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juni 2013
Senast verifierad
1 juni 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AL-3
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .