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Contact lens fitting characteristics study

The effect of contact lens parameters and material on fitting characteristics - pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16821484
Enrollment
20
Registered
2020-06-25
Start date
2020-07-29
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Presbyopia multifocal contact lens fitting Eye Diseases Presbyopia

Interventions

Each participant uses all 3 contact lenses in a random order for a 2 hour period, after which the contact lens fitting measurement and comfort measurement are being carried out. 1. Me

Sponsors

Cooper Vison Inc. (USA)
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 contact lens wearer 7. Spectacle refraction: Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00DC to -0.75DC Near Addition: +0.75D to +1.25D 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. 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 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
Contact lens decentration is measured from high speed video taken after 2 h of wear

Secondary

MeasureTime frame
Measured after 2 h of wear: 1. Lens centration rating on a 5 point scale by investigator using a slit lamp biomicroscope 2. Lens movement rating on a 5 point scale by investigator using a slit lamp biomicroscope 2. Comfort rating by participant using a computer based 100 point VAS scale

Countries

United Kingdom

Contacts

Public ContactDeborah Moore
dmoore@otg.co.uk+44 (0)207 222 4224

Outcome results

None listed

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