Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Multifocal Lens Centration and Its Effect on Visual Performance in a Presbyopic Population (BUICK)

28. maj 2015 opdateret af: University of Waterloo

The purpose of this study is to use a corneal topographer, a device that is readily available in most optometric practices, in order to determine the position of the multifocal (MF) contact lens (CL) optics in relation to the optics of the eye. The specific purpose of this study is to evaluate if there is a relationship between the positioning of the optics of the study lenses and the objective and subjective visual performance as well as participant satisfaction. The MF CL lenses will be fitted to two groups of participants (previously unsuccessful vs. currently successful MF CL wearers).

HYPOTHESES

  • The measurement of the power distribution acquired from the Medmont E300 corneal topographer is effective in determining MF CL lens centration and is a predictor of MF CL success.
  • There is a difference in MF CL centration, determined by corneal topography, between successful and unsuccessful MF CL wearers.
  • MF CL centration, determined by corneal topography, is correlated with visual performance, determined by ocular aberrometry, measures of visual acuity and subjective satisfaction.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

35

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • Centre for Contact Lens Research, University of Waterloo

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

42 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  1. Is at least 42 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Has previous experience with wearing MF CLs;
  5. Is able to be successfully fitted with all study lenses;
  6. Has a vertex-corrected spherical distance prescription of +6.00 to 8.00D (inclusive) in both eyes;
  7. Has a spectacle cylinder ≤0.75D in both eyes;
  8. Requires a reading addition of ≥+1.00D;

Exclusion Criteria:

A person will be excluded from the study if he/she:

  1. Is participating in any concurrent clinical or research study;
  2. Has any known active* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  6. Is pregnant, lactating or planning a pregnancy at the time of enrolment;
  7. Is aphakic;
  8. Has undergone refractive error surgery;
  9. Has monocular best-corrected VA of worse than 20/30 in each eye;
  10. Has amblyopia or strabismus;
  11. Has anisometropia >2D between both eyes

    • For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Acuvue Oasys for Presbyopia
Acuvue Oasys for Presbyopia contact lenses worn
Acuvue Oasys for Presbyopia contact lenses worn
Eksperimentel: PureVision2 for Presbyopia
PureVision2 for Presbyopia contact lenses worn
PureVision2 for Presbyopia contact lenses worn
Eksperimentel: Biofinity Multifocal
Biofinity Multifocal contact lenses worn
Biofinity Multifocal contact lenses worn

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decentration
Tidsramme: Day 1
Decentration (in mm and axis of decentration) of the multifocal contact lens optical center relative to ocular reference points (e.g. the pupil center or the line of sight), determined using difference maps produced by the Medmont E300 corneal topographer.
Day 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual Acuity (high contrast) at distance
Tidsramme: Day 1
Visual Acuity (high contrast) (logMAR) at distance 6m
Day 1
Visual Acuity (high contrast) at intermediate distance
Tidsramme: Day 1
Visual Acuity (high contrast) (logMAR) at intermediate distance 1m
Day 1
Visual Acuity (high contrast) at near
Tidsramme: Day 1
Visual Acuity (high contrast) (logMAR) at near (0.4m)
Day 1
Visual Acuity (low contrast) at distance
Tidsramme: Day 1
Visual Acuity (low contrast) at distance 6m
Day 1
Visual Acuity (low contrast) at intermediate distance
Tidsramme: Day 1
Visual Acuity (low contrast) (logMAR) at intermediate distance 1m
Day 1
Visual Acuity (low contrast) at near
Tidsramme: Day 1
Visual Acuity (low contrast) (logMAR) at near (0.4m)
Day 1
Overall subjective rating of lens performance in real world tasks
Tidsramme: Day 1
Participants rate overall satisfaction with vision with the contact lenses on a scale of 0-100, where 0=completely dissatisfied and 100=completely satisfied, after completing a series of real world tasks.
Day 1
Ocular aberrometry
Tidsramme: Day 1
Ocular aberrometry as measured by a LADARWave aberrometer
Day 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Lyndon Jones, PhD, CCLR, University of Waterloo

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2014

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. april 2015

Datoer for studieregistrering

Først indsendt

26. august 2014

Først indsendt, der opfyldte QC-kriterier

26. august 2014

Først opslået (Skøn)

28. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20067

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Acuvue Oasys for Presbyopia

3
Abonner