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Multifocal contact lenses fitting methods comparison

Biofinity® Multifocal contact lenses fitting methods comparison

Status
Recruiting
Phases
Unknown
Study type
Unknown
Source
ISRCTN
Registry ID
ISRCTN51153627
Enrollment
25
Registered
2022-10-26
Start date
2022-10-10
Completion date
Unknown
Last updated
2023-06-13

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

Conditions

Presbyopia Eye Diseases

Interventions

Multifocal contact lenses are prescribed to provide wearers with good vision satisfaction and visual performance using the manufacturer's prescribing routine. This study will investigate two methods o

Sponsors

CooperVision International Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 40 years old and over 2. Have read and understood the Participant Information Sheet 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 contact lens wearer 7. Spectacle refraction: 7.1. Distance: 7.1.1. Sphere -6.00D to + 4.00D 7.2.1. Astigmatism 0.00D to -0.75D 7.2. Near Addition: 7.2.1. Established Presbyopes: +1.50D and +1.75D 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. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 2. Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator 3. Monocular participants (only one eye with functional vision) or participants fit with only one lens 4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit 5. History of herpetic keratitis, ocular surgery or irregular cornea 6. Known pregnancy or lactation during the study period 7. 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
1. Overall binocular vision satisfaction measured using a 100-point visual analogue scale (VAS) after one week of wear 2 Overall preference measured using a forced choice scale at the completion of the study

Secondary

MeasureTime frame
1. Mean binocular visual performance measured using timed logMAR mean visual acuity after one week of wear 2. Number of contact lenses needed per participant to determine the contact lens pair to be dispensed

Countries

England, United Kingdom

Contacts

Public ContactDeborah Moore
dmoore@otg.co.uk+44 (0)7710645211

Outcome results

None listed

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