Multifocal Contact Lenses Fitting Methods Comparison
- Conditions
- Presbyopia
- Interventions
- Device: Control Lenses (control fitting approach)Device: Test Lenses (test fitting approach)
- Registration Number
- NCT05734846
- Lead Sponsor
- Coopervision, Inc.
- Brief Summary
The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.
- Detailed Description
This was a prospective, cross-over, double-masked (participants and investigator), randomized order of testing study. It compared two fitting approaches for silicone hydrogel multifocal contact lenses to assess which method achieved greater vision satisfaction and performance.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- At least 40 years old;
- Have read and understood the Participant Information Sheet;
- Have read, signed and dated the Informed Consent;
- Best corrected visual acuity of at least 20/25 in each eye;
- Have normal eyes with the exception of the need for visual correction;
- Current multifocal contact lens wearer;
- Spectacle refraction:
Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: Established Presbyopes: +1.50D & +1.75D
- Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
- Monocular participants (only one eye with functional vision) or participants fit with only one lens;
- Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit;
- History of herpetic keratitis, ocular surgery or irregular cornea;
- Known pregnancy or lactation during the study period;
- 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
- CROSSOVER
- Arm && Interventions
Group Intervention Description Control Lenses, then Test Lenses Test Lenses (test fitting approach) Participants wore the Control Lenses for 1 week, then crossed over to the Test Lenses for 1 week. Test Lenses, then Control Lens Test Lenses (test fitting approach) Participants wore the Test Lenses for 1 week, then crossed over to the Control Lenses for 1 week. Control Lenses, then Test Lenses Control Lenses (control fitting approach) Participants wore the Control Lenses for 1 week, then crossed over to the Test Lenses for 1 week. Test Lenses, then Control Lens Control Lenses (control fitting approach) Participants wore the Test Lenses for 1 week, then crossed over to the Control Lenses for 1 week.
- Primary Outcome Measures
Name Time Method Overall Lens Preference Two weeks Participants selected their preferred lens fitting approach from options - 'Control', 'Test', or 'No Preference'
Overall Vision Satisfaction One week Overall vision satisfaction for each lens was measured on a 0-100 point Visual Analog Scale (VAS), where 0=Extremely Unsatisfied and 100=Extremely Satisfied
- Secondary Outcome Measures
Name Time Method Overall Binocular Visual Acuity Index One week Mean binocular visual performance for each lens was measured by timed logMAR charts. Overall binocular logMAR visual acuity index was calculated by taking the mean of distance and near visual acuities
Number of Contact Lenses One week This measured the ease of fitting each contact lens. It counted the number of contact lenses (pair), selected as per the fitting guide, used to determine the final contact lens to dispense.
Trial Locations
- Locations (1)
Ocular Technology Group - International
🇬🇧London, United Kingdom