Effect of correcting astigmatism on multifocal contact lens performance and acceptance

Not Applicable

• Conditions: Vision correction of astigmatic presbyopes using multifocal contact lenses; Eye Diseases; Astigmatism

• Registration Number: ISRCTN10514147
• Lead Sponsor: CooperVision International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 11 October 2021
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 16

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Overall binocular visual acuity measured in logMAR after approximately 1 hour of contact lens wear<br> 2. Overall binocular visual satisfaction measured by 100-point visual analogue scale (VAS) after approximately 1 hour of contact lens wear<br>

Secondary Outcome Measures

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