Presbyopia, multi-focal contact lenses, vision Eye Diseases Presbyopia
Conditions
Interventions
It is important that the multifocal contact lenses prescribed for an invididual perform as intended and provide the wearers with good overall satisfaction, visual performance and the prescribing routi
Sponsors
CooperVision Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: There are no requirements as to participant race, gender or occupation. In order to be enrolled, each participant shall meet the following 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: Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: +0.75D to +2.50D in three groups: Emerging Presbyopes: +0.75D to +1.25D Established Presbyopes: +1.50D and +1.75D Advanced presbyopes: +2.00D 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: The following are specific criteria that exclude a candidate from enrolment in this study: 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
| Measure | Time frame |
|---|---|
| Overall subjective binocular visual satisfaction score on a 100-point Visual Analog Scale (VAS) at dispensing and after one week wear | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Binocular visual acuity measurements using LogMAR charts after 1 week wear 2. The number of contact lenses needed per eye to determine the contact lens to be dispensed at dispensing visit | — |
Countries
United Kingdom
Contacts
Public ContactTrisha Patel
Outcome results
None listed