Performance and acceptance of multifocal contact lenses
- Conditions
- Eye DiseasesPresbyopia
- Registration Number
- ISRCTN14349364
- Lead Sponsor
- CooperVision International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 45
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 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: -6.00D 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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall vision satisfaction measured on a 110-point analog scale after 1 week of wear
- Secondary Outcome Measures
Name Time Method <br> 1. Overall visual performance measured by LogMAR visual acuity after 1 week of wear<br> 2. The number of contact lenses tested to determine the contact lens power to be used during the study<br>