Biofinity Fitting Method Study
Research type
Research Study
Full title
Biofinity® Multifocal Contact Lenses Fitting Methods Comparison
IRAS ID
319324
Contact name
Michel Guillon
Contact email
Sponsor organisation
CooperVision International Limited
ISRCTN Number
ISRCTN51153627
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
The correction of presbyopia (different prescriptions for far and near) with contact lens is undertaken by using progressive contact lenses with a range of optical powers in front of the pupil area. The distribution of the optical powers leads in some cases to favoring distance or near vision, the aim being to reach an optimal balance to give good vision at both far and near.
Biofinity® Multifocal contact lenses are well established CE marked contact lenses which include a range of designs to achieve the best balance between far and near vision. For participants with established presbyopia (near addition +1.50D & +1.75D) eyecare practitioners follow different approaches to select the contact lenses to dispense. Some use two designs favoring far vision (Design D), while other use the design favoring far vision in one eye (Design D) and the design favoring near vision in the other (Design N).
The current study will compare the acceptance and preference of the two clinical approaches in a controlled manner over a one week of wear of each combinations by a group of participants who are current multifocal contact lens wearers. The study will be a double masked, cross-over study which will involve up to 30 participants being screened into the study. The clinical routine will involve three visits: i. visit 1 enrolment dispensing of study contact lens order 1; ii. visit 2 follow-up study contact lens order 1 and dispensing study contact lens order 2; iii. visit 3 follow-up study contact lens order 2.REC name
London - Bloomsbury Research Ethics Committee
REC reference
22/PR/1137
Date of REC Opinion
4 Oct 2022
REC opinion
Further Information Favourable Opinion