Effect of multifocal contact lenses on binocular vision
| ISRCTN | ISRCTN13386434 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13386434 |
| IRAS number | 305799 |
| Secondary identifying numbers | CV21-69 ID21-69, IRAS 305799 |
- Submission date
- 18/10/2021
- Registration date
- 18/10/2021
- Last edited
- 12/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Part of the development of new multifocal contact lens designs involves comparing them with other marketed contact lenses and also monovision contact lenses to ensure there is no loss of binocular vision. Binocular vision refers to how the eyes work together to produce a three-dimensional perception of the world. This study aims to compare control multifocal contact lenses versus test multifocal contact lenses and a control monovision contact lens compared to the test multifocal contact lenses.
Who can participate?
Adults who are at least 40 years old, have healthy eyes and wear multifocal contact lenses.
What does the study involve?
The study involves two non-dispensing visits where a series of vision measurements will be carried out while participants wear different pairs of contact lenses for 1 hour each. Each visit will take about 6 hours in the clinic and they will be 2-14 days apart.
What are the possible benefits and risks of participating?
Participants will use contact lenses that are CE marked. The risk to participants is no greater than wearing their own contact lenses. The risks are further minimised by the fact that the contact lenses will only be worn in the clinic under the supervision of the investigators. The possible benefit to the participant is for them to experience different types of contact lenses that they may not have tried before.
Where is the study run from?
Ocular Technology Group - International (UK)
When is the study starting and how long is it expected to run for?
July 2021 to December 2021
Who is funding the study?
CooperVision International Limited (UK)
Who is the main contact?
Deborah Moore
dmoore@otg.co.uk
Contact information
Public
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)207 2224224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Single-centre interventional double-masked randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Quantification of binocular summation of multifocal and monovision contact lenses |
| Study objectives | 1. Improvement in overall binocular visual acuity from monocular acuity is non-inferior to that achieved with the test multifocal contact lenses is non-inferior to that with the control multifocal contact lenses 2. The improvement in overall binocular visual acuity from overall binocular visual acuity from monocular acuity with the test multifocal contact lenses is superior to that achieved with the control monovision contact lenses |
| Ethics approval(s) | Approved 14/10/2021, North of Scotland Research Ethics Committee (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458; gram.nosres@nhs.scot), REC ref: 21/NS/0131 |
| Health condition(s) or problem(s) studied | Presbyopia |
| Intervention | In this study the researchers will measure the visual performance and binocular performance of various control multifocal contact lenses compared to a test multifocal contact lens, and a control monovision contact lens to a test multifocal contact lens. The study involves two non-dispensing visits where a series of vision measurements will be carried out while participants are randomised using randomization.com to wear different pairs of contact lenses (MyDay Multifocal, MyDay Spherical, Biofinity Multifocal, Acuvue Moist Multifocal) for 1 hour each. Each visit will take about 6 hours in the clinic and they will be 2-14 days apart. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | MyDay Multifocal, MyDay Spherical, Biofinity Multifocal, Acuvue Moist Multifocal |
| Primary outcome measure | 1. Overall binocular timed visual acuity measured in logMAR after approximately 30 minutes of contact lens wear 2. Overall monocular timed visual acuity measured in logMAR after approximately 30 minutes of contact lens wear 3. Binocular vision measured in arcseconds after approximately 1 hour of contact lens wear |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 18/07/2021 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 21 |
| Key inclusion criteria | 1. 40 or more years of age 2. Have read and understood the Participant Information Sheet in English 3. Have read, signed and dated the Informed Consent 4. Current multifocal contact lens wearer 5. Spectacle refraction: Distance: Sphere: -6.00D to + 4.00DS Astigmatism: -0.00DC to -0.75DC in each eye Near Addition: +0.75D to +2.50D 6. Best corrected visual acuity of at least 20/25 in each eye 7. Have normal eyes with the exception of the need for visual correction 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule |
| Key exclusion criteria | 1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 2. Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator 3. Monocular participants (only one eye with functional vision) or participants fit with only one lens 4. Any moderate or severe ocular condition observed during the slit lamp examination at the enrolment visit 5. History of herpetic keratitis, ocular surgery or irregular cornea 6. Known pregnancy or lactation during the study period 7. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals |
| Date of first enrolment | 18/10/2021 |
| Date of final enrolment | 01/12/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW1E 6AU
United Kingdom
Sponsor information
Industry
Delta Park
Concorde Pay
Segensworth North
Fareham
PO15 5RL
England
United Kingdom
| Phone | +1 (0)925 251 6682 |
|---|---|
| tdoan@coopervision.com | |
| Website | http://coopervision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | There are currently no plans for publication or dissemination of the study results. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 31/01/2022 | 12/04/2022 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
12/04/2022: The following changes have been made:
1. The basic results of this trial have been uploaded as an additional file.
2. The total final enrolment number has been added.
18/10/2021: Trial's existence confirmed by the North of Scotland Research Ethics Committee.
