N/A
Completed N=142
Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal
Source: ClinicalTrials.gov NCT01591499 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Visual Performance - Comparison of Initial Refraction to Multifocal Lenses — 65.3; 48.3; 49.1 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Performance - Comparison of Initial Refraction to Multifocal Lenses |
65.3; 48.3; 49.1 | — |
| SECONDARY Visual Performance - Near Visual Acuity |
122; 49; 51; 12; 10; 7 | — |
| SECONDARY Visual Performance - Distance Visual Acuity |
10.18; 9.87; 10.28 | — |
| SECONDARY Visual Performance - Quality of Near Vision |
83.19; 70.97; 71.27 | — |
| SECONDARY Visual Performance - Quality of Intermediate Vision |
81.25; 75.67; 76.08 | — |
| SECONDARY Visual Performance - Quality of Distance Vision |
73.54; 74.18; 74.33 | — |
| SECONDARY Visual Performance - Near, Low Contrast Vision |
33.82; 31.76; 34.64 | — |
| SECONDARY Visual Performance: Near, High Contrast Vision |
53.91; 49.11; 52.83 | — |
| SECONDARY Visual Performance: Distance, Low Contrast Vision |
19.09; 17.77; 18.77 | — |
| SECONDARY Visual Performance: Distance, High Contrast Vision |
39.76; 36.63; 38.75 | — |
| SECONDARY Visual Performance - Near Stereoscopic Vision |
7.01; 6.21; 6.7 | — |
| SECONDARY Subjective Rating of Lens Comfort, Fitting |
86.27; 80.77; 73.46 | — |
| SECONDARY Subjective Rating of Lens Comfort - During Day |
84.95; 81.54; 73.41 | — |
| SECONDARY Subjective Rating of Lens Comfort - End of Day |
77.98; 73.51; 61.6 | — |
| SECONDARY Subjective Rating of Lens Comfort - General Comfort |
85.66; 81.72; 70.75 | — |
| SECONDARY Comfort of Use - Average Wearing Time |
11.61; 10.7; 11.27 | — |
| SECONDARY Geometric Performance - Lens Centration |
122; 57; 54; 4; 4; 8 | — |
| SECONDARY Geometric Performance - Lens Mobility |
116; 58; 49; 13; 4; 13 | — |
| SECONDARY Clinical Performance - Lens Wettability |
31.1; 53.8; 52.4; 68.9; 46.2; 47.6 | — |
| SECONDARY Lens Preference - Participant |
59.7; 77.0; 68.3; 40.3; 0; 20.3 | — |
| SECONDARY Lens Preference - Ophthalmologist |
64.5; 80.0; 72.1; 35.5; 0; 18.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01591499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.