Miru Multifocal Contact Lens Performance and Acceptance Assessment

  • Research type

    Research Study

  • Full title

    Miru Multifocal Contact Lens Performance and Acceptance Assessment following daily wear use of one week.

  • IRAS ID

    274407

  • Contact name

    Kishan Patel

  • Contact email

    kpatel@otg.co.uk

  • Sponsor organisation

    CooperVision, Inc.

  • Duration of Study in the UK

    0 years, 6 months, 12 days

  • Research summary

    Presbyopia is a condition associated with aging in which the eye exhibits a progressively diminished ability to focuson near objects. When correcting presbyopia with contact lenses, multifocal designs are used to correct vision at far, intermediate and near distances. Miru 1-month multifocal contact lenses has unique optical design that incorporates a near optical zone positioned nasally from the apex of the cornea. The design rationale is that the visual axis is located temporally, hence moving the optical zone in that manner should produce a superior visual performance and acceptance than a concentric design. Therefore it is of interest to determine if the decentred optical design will result in a better visual performance compared to a known and commonly used concentric optical design. Up to 45 participants will be screened into three near reading addition groups (up to 15 per add group of low, medium and high). Participants will wear two multifocal contact lenses (test: Miru, control: Acuvue Moist) in a randomized sequence for a week. There will be three study visits over a two-week period. Both contact lenses are CE marked and each multifocal lens type will be worn for a week on a daily wear and daily disposable basis. Lenses will be prescribed as per manufacturer's fitting guide. Both participant and investigator will be masked. Overall subjective visual satisfaction score using visual analog scale 0-100 and visual acuity measurements will be used to compare the two multifocal optical designs.

  • REC name

    North West - Preston Research Ethics Committee

  • REC reference

    19/NW/0713

  • Date of REC Opinion

    17 Dec 2019

  • REC opinion

    Further Information Favourable Opinion