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Effect of correcting astigmatism on multifocal contact lens performance and acceptance

Effect of correcting astigmatism 20 degrees off-axis on multifocal visual performance and acceptance

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10514147
Enrollment
18
Registered
2021-06-07
Start date
2021-06-10
Completion date
Unknown
Last updated
2021-10-11

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

Conditions

Vision correction of astigmatic presbyopes using multifocal contact lenses Eye Diseases Astigmatism

Interventions

Multifocal contact lenses are used in wearers with various levels of astigmatism. It is important to understand the effect of astigmatism on visual performance of multifocal contact lenses. In this st

Sponsors

CooperVision International Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 40 or more years of age 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 multifocal contact lens wearer 7. Spectacle refraction: Distance: Sphere: -6.00 D to + 4.00 DS Astigmatism: -0.50 DC to -1.25 DC in both eyes Near Addition: +0.75 D to +2.50 D 8. 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 visual acuity measured in logMAR after approximately 1 hour of contact lens wear 2. Overall binocular visual satisfaction measured by 100-point visual analogue scale (VAS) after approximately 1 hour of contact lens wear

Secondary

MeasureTime frame
1. Individual monocular and binocular timed visual acuity measured in logmAR after approximately 1 hour of contact lens wear 2. Overall monocular timed visual acuity in the dominant eye measured in logMAR after approximately 1 hour of contact lens wear 3. Overall monocular timed visual acuity in the non-dominant eye measured in logMAR after approximately 1 hour of contact lens wear 4. Individual visual satisfaction at distance, intermediate, and near, measured by 100-point VAS after approximately 1 hour of contact lens wear

Countries

England, United Kingdom

Contacts

Public ContactDeborah Moore
dmoore@otg.co.uk+44 (0)2072224224

Outcome results

None listed

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