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Satisfaction with multifocal contact lenses

Visual satisfaction with a multifocal lens design combination: a randomized cross-over study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10092153
Enrollment
40
Registered
2016-10-28
Start date
2016-10-03
Completion date
Unknown
Last updated
2018-02-19

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

Conditions

Presbyopia Eye Diseases Presbyopia

Interventions

The two types of multifocal contact lenses to be tested differ in their power profiles across the lens (zones for distance, intermediate and near correction of vision). Participants' eyes will be exam

Sponsors

CooperVision Inc.
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 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: 8. Distance: Sphere: -6.00D to + 4.00D, Astigmatism: 0.00D to -0.75D 9. Near Addition: +0.75D to +2.50D in three groups: 9.1. Emerging presbyopes: +0.75D to +1.25D 9.2. Established presbyopes:+1.50D and +1.75D 9.3. Advanced presbyopes: +2.00D to +2.50D 10. 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 contraindicates 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
Subjective assessment of overall visual satisfaction, measured using a 100-point Visual Analog Scale (VAS) at the dispensing visit and follow-up visit for each of the lens types

Secondary

MeasureTime frame
Binocular visual performance, measured using high and low contrast LogMAR visual acuity charts at distance (4m), intermediate (67cm) and near (40cm) under high, medium and low levels of illumination, at the follow-up visit for each lens type

Countries

United Kingdom

Contacts

Public ContactTrisha Patel

Outcome results

None listed

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