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Multifocal contact lens performance and acceptance

Miru multifocal contact lens performance and acceptance assessment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN54358864
Enrollment
45
Registered
2021-01-28
Start date
2020-03-05
Completion date
Unknown
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia vision correction using multifocal contact lenses Eye Diseases

Interventions

Each participant attends the clinic on three occasions. At the first visit after being screened and enrolled in the study, their eyes are examined and they are fitted and dispensed wit

Sponsors

CooperVision (United States)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At least 40 years old 2. Have read and understood the Participant Information Sheet in English 3. Have read, signed and dated the Informed Consent 4. Best corrected visual acuity of at least 20/25 in each eye 5. Have normal eyes with the exception of the need for visual correction 6. Current multifocal soft contact lens wearer 7. Spectacle refraction: Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: +0.75D to +2.50D 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Exclusion criteria

Exclusion criteria: 1. Currently wearing study contact lenses 2. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 3. Newly prescribed use of some systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator 4. Monocular participants (only one eye with functional vision) or participants fit with only one lens 5. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit 6. History of herpetic keratitis, ocular surgery or irregular cornea 7. Known pregnancy or lactation during the study period 8. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals

Design outcomes

Primary

MeasureTime frame
Overall binocular vision satisfaction measured on a 100 point Visual Analogue scale at the end of the wearing period 7 +2/-1 days of wear.

Secondary

MeasureTime frame
Overall binocular visual performance measured as the mean of the distance and near LogMar visual acuity after 7 +2/-1 days of wear.

Countries

United Kingdom

Contacts

Public ContactDeborah Moore
dmoore@otg.co.uk+44 (0)207 2224224

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026