Effect of correcting astigmatism on multifocal contact lens performance and acceptance
| ISRCTN | ISRCTN10514147 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10514147 |
| IRAS number | 300445 |
| Secondary identifying numbers | ID21-32 CV21-37, IRAS 300445 |
- Submission date
- 07/06/2021
- Registration date
- 07/06/2021
- Last edited
- 29/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
Astigmatism means the eye is shaped more like a rugby ball than a football, so light is focused at more than one place in the eye. Astigmatism, along with short sight and long sight, is a common cause of blurry vision. It is usually corrected with glasses or contact lenses. Multifocal contact lens wearers have varying low degrees of astigmatism which affect both visual performance and visual satisfaction. The aim of this study is to measure the effect of astigmatism on visual acuity and vision satisfaction when wearing multifocal contact lenses.
Who can participate?
Adults who are at least 40 years old, have healthy eyes, wear multifocal contact lenses, and have astigmatism from -0.50DC to -1.25DC in both eyes.
What does the study involve?
The study involved a single visit where a series of vision measurements will be carried out while participants wear some contact lenses and spectacles over the top. The whole visit will take about 5 hours in the clinic.
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 the effect of correcting their astigmatism on their vision.
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?
April 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
Lower Ground Floor
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)2072224224 |
|---|---|
| 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 | Effect of correcting astigmatism 20 degrees off-axis on multifocal visual performance and acceptance |
| Study hypothesis | The hypotheses to be tested will be: 1. Visual performance of multifocal contact lenses with astigmatism corrected 20° off-axis is not inferior to visual performance of multifocal contact lenses without astigmatic correction 2. Visual acceptance of multifocal contact lenses with astigmatism corrected 20° off-axis is not inferior to visual acceptance of multifocal contact lenses without astigmatic correction |
| Ethics approval(s) | Approved 03/06/2021, London - Westminster Research Ethics Committee (The Old Chapel, Rotal Standard Place, Nottingham, NG1 6FS, UK; 44(0)207 104 8388; westminster.rec@hra.nhs.uk), REC ref: 21/PR/0749 |
| Condition | Vision correction of astigmatic presbyopes using multifocal contact lenses |
| Intervention | Multifocal contact lenses are used in wearers with various levels of astigmatism. It is important to understand the effect of astigmatism on visual performance of multifocal contact lenses. In this study the researchers will measure visual performance and visual satisfaction for patients while adding an astigmatic correction, compared to when there is no astigmatic correction. Randomisation is computer-generated for the order of testing the different corrections. There is only one intervention arm as it is a cross over study. The contact lenses worn by participants will be MyDay Multifocal contact lenses worn as per their CE marking. Participants will also wear two different sets of spectacles in a random order to provide an over-correction. One set of spectacles will be plano, another set of spectacles will provide an astigmatic correction. Each correction is only worn for approx. 2 hours in the clinic. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | MyDay Multifocal |
| Primary outcome measure | 1. Overall binocular visual acuity measured in logMAR after approximately 1 hour of contact lens wear 2. Overall binocular visual satisfaction measured by 100-point visual analogue scale (VAS) after approximately 1 hour of contact lens wear |
| Secondary outcome measures | 1. Individual monocular and binocular timed visual acuity measured in logmAR after approximately 1 hour of contact lens wear 2. Overall monocular timed visual acuity in the dominant eye measured in logMAR after approximately 1 hour of contact lens wear 3. Overall monocular timed visual acuity in the non-dominant eye measured in logMAR after approximately 1 hour of contact lens wear 4. Individual visual satisfaction at distance, intermediate, and near, measured by 100-point VAS after approximately 1 hour of contact lens wear |
| Overall study start date | 23/04/2021 |
| Overall study end date | 31/12/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Up to 25 participants will be screened with the aim to enrol 18 |
| Total final enrolment | 16 |
| Participant 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. Best corrected visual acuity of at least 20/25 in each eye 5. Have normal eyes with the exception of the need for visual correction 6. Current multifocal contact lens wearer 7. Spectacle refraction: Distance: Sphere: -6.00 D to + 4.00 DS Astigmatism: -0.50 DC to -1.25 DC in both eyes Near Addition: +0.75 D to +2.50 D 8. Willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule |
| Participant 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 |
| Recruitment start date | 10/06/2021 |
| Recruitment end date | 31/10/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
Sponsor information
Industry
Delta Park
Concorde Way
Segensworth North
Fareham
PO15 5RL
United Kingdom
| Phone | +1 (0)925 251 6682 |
|---|---|
| tdohn@coopervision.com | |
| Website | http://coopervison.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 | 28/09/2021 | 29/09/2021 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
29/09/2021: The basic results of this trial have been uploaded as an additional file.
07/06/2021: Trial's existence confirmed by London - Westminster Research Ethics Committee.
