The effect of astigmatism on multifocal contact lens visual performance
| ISRCTN | ISRCTN47409350 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47409350 |
| IRAS number | 271679 |
| Secondary identifying numbers | CV19-64 ID19-38, IRAS 271679 |
- Submission date
- 10/12/2020
- Registration date
- 27/01/2021
- Last edited
- 29/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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, who have healthy eyes and wear multifocal contact lenses and have astigmatism from -0.50 D in both eyes or -0.75 DC to -1.25 DC in one eye.
What does the study involve?
The study involves a single visit where a series of vision measurements will be carried out. Participants wear MyDay Multifocal and Proclear 1Day Multifocal contact lenses for about 2 hours each in the clinic.
What are the possible benefits and risks of participating?
The participants are current multifocal contact lens wearers and they will use multifocal contact lenses which are CE marked. The risk to the 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 from and how long is it expected to run for?
May 2019 to December 2019
Who is funding the study?
CooperVision Inc. (USA)
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)207 222 4224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Prospective randomized double-masked single-group crossover study |
|---|---|
| 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 the contact details to request a participant information sheet |
| Scientific title | The effect of astigmatism on multifocal contact lens visual performance - a pilot study |
| Study objectives | The study is a pilot feasibility study so formal hypothesis testing is not possible. Multifocal contact lenses are used in patients with astigmatism up to 0.75DC as per their CE marking. The rationale for the study is to measure the effect of astigmatism of the visual performance on multifocal contact lenses. |
| Ethics approval(s) | Approved 25/09/2019, West Midlands - Solihull Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8191; NRESCommittee.WestMidlands-Solihull@nhs.net), REC ref: 19/WM/0270 |
| Health condition(s) or problem(s) studied | Presbyopia vision correction 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 with different levels of astigmatism. Randomisation is computer-generated for the order of testing the different corrections (MyDay Multifocal and Proclear 1Day Multifocal). There is only one intervention arm as it is a cross over study. 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, Proclear 1Day Multifocal |
| Primary outcome measure | Visual performance (overall binocular and monocular) measured using LogMar charts at approximately 30 mins after the contact lenses are inserted |
| Secondary outcome measures | Visual satisfaction (overall binocular and monocular) measured using LogMar charts at approximately 30 mins after the contact lens are inserted |
| Overall study start date | 01/05/2019 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 45 |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. At least 40 years old 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: -6.00DS to + 4.00DS Astigmatism: a. -0.50 DC in both eyes or b. -0.75 DC to -1.25 DC in one eye Near Addition: +0.75 D to +2.50 D 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. Newly prescribed use of some 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 | 01/09/2019 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW1E 6AU
United Kingdom
Sponsor information
Industry
6150 Stoneridge Mall Road
Pleasanton
94588
United States of America
| Phone | +1 (0)925 251 6682 |
|---|---|
| plazon@coopervision.com | |
| Website | http://coopervision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| 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 no specific 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 | 28/01/2021 | 29/01/2021 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN47409350_BasicResults_28Jan2021.docx
- uploaded 29/01/2021
Editorial Notes
29/01/2021: The basic results of this trial have been uploaded as an additional file.
10/12/2020: Trial's existence confirmed by West Midlands - Solihull Research Ethics Committee.
