Clinical Evaluation of the Biofinity Multifocal Lens Compared With the Air Optix Aqua Multifocal Lens and With PureVision Multifocal Lens (INNOVATION PRESBYOPIA Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 主要终点
- Visual Performance - Comparison of Initial Refraction to Multifocal Lenses
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, aged 18 years or older
- •Patients with proven presbyopia
- •Patients who do not wear contact lenses or who wore spherical lenses before being included in the study
- •Myopic patients whose spherical equivalent is less than or equal to 9.00 D (or a "lens" power less than or equal to -8,00 D) or hypermetropic patients whose spherical equivalent is less than or equal to +5.50 D (or a "lens" power less than or equal to +6,00 D) or emmetropic patients for distance vision (plan)
- •Patient able to fill in a diary without help
- •Patients who gave their informed consent to take part in the study
排除标准
- •Patients with a contra-indication for wearing contact lenses
- •Patients suffering from any ocular pathology that might interfere with the evaluation of the lenses
- •Patients wearing multifocal lenses or spherical lenses for monovision before being included in the study
- •Astigmatic patients whose cylinder is more than 0.75 D
研究组 & 干预措施
BIOFINITY® MF - AIR OPTIX® AQUA MF
During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity)
干预措施: BIOFINITY® MF - AIR OPTIX® AQUA MF (Device)
BIOFINITY® MF - AIR OPTIX® AQUA MF
During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity)
干预措施: BIOFINITY® MF - PUREVISION® MF (Device)
BIOFINITY® MF - PUREVISION® MF
During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity)
干预措施: BIOFINITY® MF - AIR OPTIX® AQUA MF (Device)
BIOFINITY® MF - PUREVISION® MF
During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity)
干预措施: BIOFINITY® MF - PUREVISION® MF (Device)
结局指标
主要结局
Visual Performance - Comparison of Initial Refraction to Multifocal Lenses
时间窗: 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
次要结局
- Subjective Rating of Lens Comfort, Fitting(Measured at V3 or V5)
- Visual Performance - Near Visual Acuity(Measured at V3 or V5)
- Visual Performance - Distance Visual Acuity(Measure at V3 or V5)
- Visual Performance - Quality of Near Vision(Measured at V3 or V5)
- Visual Performance - Quality of Intermediate Vision(Measured at V3 or V5)
- Visual Performance: Distance, High Contrast Vision(Measured at V3 or V5)
- Visual Performance - Quality of Distance Vision(Measured at 17-24 days V3 or V5)
- Visual Performance - Near, Low Contrast Vision(Measured at V3 or V5)
- Visual Performance: Near, High Contrast Vision(Measured at 17-24 days V3 or V5)
- Visual Performance: Distance, Low Contrast Vision(Measured at V3 or V5)
- Visual Performance - Near Stereoscopic Vision(Measured at V3 or V5)
- Subjective Rating of Lens Comfort - During Day(Measured at V3 or V5)
- Subjective Rating of Lens Comfort - End of Day(Measured at V3 or V5)
- Subjective Rating of Lens Comfort - General Comfort(Measured at V3 or V5)
- Comfort of Use - Average Wearing Time(Measured at V3 or V5)
- Lens Preference - Participant(Measured at V5)
- Geometric Performance - Lens Centration(Measured at V3 or V5)
- Geometric Performance - Lens Mobility(Measured at 17-24 days V3 or V5)
- Clinical Performance - Lens Wettability(Measured at 17-24 days V3 or V5)
- Lens Preference - Ophthalmologist(Measured at 17-24 days V3 or V5)