Clinical Evaluation of OneFit MED Scleral Contact Lenses
Research type
Research Study
Full title
Non Dispensing Clinical Evaluation of Customised OneFitTM MED Scleral Contact Lenses
IRAS ID
315747
Contact name
Michel Guillon
Contact email
Sponsor organisation
CooperVision International Limited
ISRCTN Number
ISRCTN16851376
Duration of Study in the UK
0 years, 9 months, 13 days
Research summary
The correction of presbyopia (people needing different distance and near vision corrections) is with contact lenses presenting a range of corrections in front of the pupil to cover the vision needs from distance to near (multifocal). Key requirements for good acceptance and performance are that the contact lenses do not move excessively and are well centred over the pupil. Traditionally soft or small hard contact lenses are used but recently large hard contact lenses (scleral) have also been used. The main benefits of scleral contact lenses are that, being larger, they are more stable and using an initial trial set they are fully customisable with the potential benefits of achieving a better centration than the other contact lens types. However, to date no known systematic analysis has been carried of the effects of the various scleral design parameters on contact lens centration. The rationale for the proposed non-dispensing study is, therefore, to study the effect of the two most important design parameters, overall sagittal height and scleral lens toricity on scleral contact lens centration.
The study will be in two phases: i. phase one which will use trial contact lenses will include two visits with two standard designs tested at each visit; ii. at the completion of phase one using the manufacturer’s commercial selection computerised grid the planned customised design will be ordered to be tested in Phase 2. For all contact lens fits a high magnification video recording will be taken and centration measured to compare the effect of the different design parameters and of the customised design on contact lens centration.REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0171
Date of REC Opinion
23 May 2022
REC opinion
Favourable Opinion