Early presbyopia Eye Diseases
Conditions
Interventions
The study will be a single-visit, in-clinic, prospective observational study followed by three remote time-controlled questionnaires implemented on three different days within the following 10-day per
Sponsors
CooperVision International Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The entry criteria will be: 1. Age 40 to 50 years 2. Vision correction: 2.1. Distance Vision Correction only 2.1.1. Single vision distance spectacles 2.1.2. Single vision distance contact lenses 2.1.3. No vision correction 3. Spectacle refraction: 3.1. Distance: Sphere: -6.00D to + 3.00D 3.2. Astigmatism: 0.00D to -2.50 4. Best corrected distance visual acuity of at least 20/25 in each eye
Exclusion criteria
Exclusion criteria: 1. Acute and subacute inflammation or infection of the anterior chamber of the eye 2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear 3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic 4. Severe insufficiency of lacrimal secretion (dry eyes) 5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema) 6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions 7. Any active corneal infection (bacterial, fungal, protozoal or viral) 8. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator 9. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens 10. Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as recorded during the clinical visit, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit 11. History of corneal refractive surgery 12. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Optical and visual characteristics of the early presbyopic population measured using time-controlled visual acuity at two points during the study visit 2. Identify differentiating factors between symptomatic and asymptomatic early presbyopes measured using subjective questionnaires during the study visit and remotely after the study visit | — |
Countries
England, United Kingdom
Contacts
Public ContactDeborah Moore
Outcome results
None listed