Correction of low astigmatism
| ISRCTN | ISRCTN42235351 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42235351 |
| IRAS number | 331203 |
| Secondary identifying numbers | CV23-42 ID23-35, IRAS 331203 |
- Submission date
- 22/09/2023
- Registration date
- 29/09/2023
- Last edited
- 30/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Astigmatism is a common eye problem that can make vision blurry or distorted. People with astigmatism can be corrected with spectacles or contact lenses. When corrected with spectacles any level of astigmatism present is always corrected. In contrast, when corrected with contact lenses low level of astigmatism is usually not corrected in routine practice. A number of studies have suggested that this approach may produce less than optimal vision in particular at night. The aim of this study is to demonstrate that low astigmatic contact lens wearers could benefit from using toric contact lenses (contact lenses that correct astigmatism) instead of standard spherical contact lenses.
Who can participate?
Adults aged 18 to 35 years who are current soft contact lens wearers and have low levels of astigmatism
What does the study involve?
Participants will attend the clinic on three separate occasions approximately one week apart. Two different contact lenses will be dispensed at the first two visits and to be worn for about a week. At visits 2 and 3 the acceptance will be assessed by the investigators.
What are the possible benefits and risks of participating?
Participants have the opportunity to try contact lenses to correct their astigmatism. Any contact lens wear comes at the risk of corneal infection, but the incidence rate is very low.
Where is the study run from?
Ocular Technology Group - International (OTG-i) (UK)
When is the study starting and how long is it expected to run for?
April 2023 to June 2024
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)2072224224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Single-centre prospective interventional double-masked cross-over randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Correction of low level of astigmatism with soft contact lenses |
| Study objectives | The primary hypothesis to be tested is that the visual acuity under mesopic light conditions with the test toric contact lens is superior to that with the control spherical contact lens. The secondary hypotheses to be tested are that: 1. Night-time vision satisfaction with the test toric contact lens is superior to that with the control spherical contact lens 2. Visual acuity in the presence of glare with the test toric contact lens is superior to that with the control spherical contact lens |
| Ethics approval(s) |
Approved 31/08/2023, North Of Scotland Ethics Committee 02 (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, United Kingdom; +44 (0)1224558458; gram.nosres@nhs.scot), ref: 23/NS/0081 |
| Health condition(s) or problem(s) studied | Astigmatism |
| Intervention | Two types of contact lenses (MyDay Toric®, MyDay® spherical) will be worn by each participant in a random order in turn for at least 7 days (7 -0./+3 days) on a daily disposable basis. Randomisation is carried out by a standard computer randomisation generator software. Each participant attends the clinic on three occasions: the first visit for enrolment, screening and contact lens order 1 dispensing, visit 2 for contact lens order 1 follow-up and contact lens order 2 dispensing, and visit 3 for contact lens order 2 follow-up and discharge. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | MyDay Toric®, MyDay® spherical |
| Primary outcome measure | Timed monocular logMAR high contrast (>90%), mesopic (2.5 cd/m2) visual acuity measured at the follow-up visits at 7 (+3/-0), 14 (+3/-0) and 21 (+3/-0) days |
| Secondary outcome measures | 1. Overall night-time vision satisfaction recorded on a 100-point VAS measured at the follow-up visits at 7 (+3/-0), 14 (+3/-0) and 21 (+3/-0) days 2. Timed monocular logMAR medium contrast, mesopic (2.5 cd/m2) visual acuity loss with the addition of a glare source measured at the follow-up visits at 7 (+3/-0), 14 (+3/-0) and 21 (+3/-0) days |
| Overall study start date | 01/04/2023 |
| Completion date | 01/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 25 |
| Key inclusion criteria | In order to be enrolled, each participant shall meet the following criteria: 1. Aged 18 to 35 years 2. Current contact lens wearer 3. Spectacle refraction: Distance: Sphere: -6.00D to + 2.00D Astigmatism: -0.50D to -1.00D with at least -0.75D in one eye 4. Best corrected visual acuity of at least 20/25 in each eye |
| Key exclusion criteria | 1. Acute and subacute inflammation or infection of the anterior chamber of the eye 2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear 3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic 4. Severe insufficiency of lacrimal secretion (dry eyes) 5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema) 6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions 7. Any active corneal infection (bacterial, fungal, protozoal or viral) 8. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator 9. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens 10. Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit 11. History of corneal refractive surgery 12. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals 13. Current wearer of the control contact lenses MyDay® spherical or the test contact lenses MyDay Toric® |
| Date of first enrolment | 22/09/2023 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW1E6AU
United Kingdom
Sponsor information
Industry
Delta Park
Concorde Way
Segensworth North
Fareham
PO15 5RL
England
United Kingdom
| Phone | +1 (0)925 2516682 |
|---|---|
| plazon@coopervision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | There are no plans at this stage for publication or dissemination. |
| 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 | 18/01/2024 | 30/01/2024 | No | No |
Additional files
Editorial Notes
30/01/2024: Basic results and total final enrolment added.
28/09/2023: Study's existence confirmed by North Of Scotland Ethics Committee 02
