Clinical Trial: Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Evaluation of the Biofinity Multifocal Lens Compared With the Air Optix Aqua Multifocal Lens and With PureVision Multifocal Lens (INNOVATION PRESBYOPIA Study)
Brief Summary: This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.
Detailed Summary:
This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.
Each subject will have 5 visits with the investigator:
- (V1) An inclusion visit during which the first pair of lenses are fitted;
- (V2) An optimization visit after 7 to 9 days of wearing the first lens;
- (V3) An evaluation visit after an additional 10 to 15 days of wearing the first lens (17 to 24 days) and at which time the second pair of lenses are fitted;
- (V4, V5) Visits are conducted as in V 2 and V3 with the second pair of lenses.
Sponsor: Coopervision, Inc.
Current Primary Outcome: Visual Performance - Comparison of Initial Refraction to Multifocal Lenses [ Time Frame: Change over time measured at V1, V3 and V5 ]
The percentage of participants who obtained binocular distance and near visual acuities (VA) at least as good as their initial refraction assessment. Measured by Initial Refraction. Distance binocular VA (at 5 meters) using the Snellen chart decimal scale and near binocular VA (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5).
Change over time measured at V1 (initial refraction) and at V3 (lens pair one evaluation) and V5 (lens pair two evaluation):
V1 = initial refraction at baseline, V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Original Primary Outcome: Visual acuity [ Time Frame: 17-24 days ]
Current Secondary Outcome:
- Visual Performance - Near Visual Acuity [ Time Frame: Measured at V3 or V5 ]
Description: The participant's near binocular visual acuity (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5) and reported per lens.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
- Visual Performance - Distance Visual Acuity [ Time Frame: Measure at V3 or V5 ]
Description: The participant's distance binocular visual acuity (at 5 meters) using the La Galinet method. (Decimal scale, Excellent=between 5 and 20 tenths at 5 metres and between 1 and 20 tenths at 40 cm)
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
- Visual Performance - Quality of Near Vision [ Time Frame: Measured at V3 or V5 ]
Patients' subjective rating for quality of near vision by patient diary and reported per lens. (40cm away: reading a newspaper, looking at your watch etc. 0-100, 0=totally blurred, 100=perfectly clear).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
- Visual Performance - Quality of Intermediate Vision [ Time Frame: Measured at V3 or V5 ]
Patients' subjective rating for quality of intermediate vision by patient diary and reported per lens. (distance equivalent to an arm's length. 0-100, 0=totally blurred, 100=perfectly clear).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
- Visual Performance - Quality of Distance Vision [ Time Frame: Measured at 17-24 days V3 or V5 ]
Patients' subjective rating for quality of distance vision by patient diary and reported per lens. (driving, looking at a landscape, etc. 0-100, 0=totally blurred, 100=perfectly clear).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
- Visual Performance - Near, Low Contrast Vision [ Time Frame: Measured at V3 or V5 ]
The number of letters read at a near of 40 centimeters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
- Visual Performance: Near, High Contrast Vision [ Time Frame: Measured at 17-24 days V3 or V5 ]
The number of letters read at a near of 40 centimeters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
- Visual Performance: Distance, Low Contrast Vision [ Time Frame: Measured at V3 or V5 ]
The number of letters read at a distance of 5 meters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
- Visual Performance: Distance, High Contrast Vision [ Time Frame: Measured at V3 or V5 ]
The number of letters read at a distance of 5 meters under 90% high contrast. Measured by objective assess
Original Secondary Outcome: Vision measures [ Time Frame: 17-24 days ]
1. quality of distance, near and intermediate range (computer work) vision, while driving at night, visual stability, presence of halos or double vision, as evaluated by patient;, 2. ease patient adjusts (simplicity evaluated by ophthalmologist and speed evaluated by patient); 3. comfort of use (ease of handling and comfort while wearing lenses) evaluated by patient, 4. contrast, near and distance vision, evaluated by ophthalmologist, 5. near stereoscopic vision, evaluated by ophthalmologist
Information By: Coopervision, Inc.
Dates:
Date Received: March 19, 2012
Date Started: September 2011
Date Completion:
Last Updated: January 7, 2016
Last Verified: January 2016
