Optimizing vision with multifocal contact lens combinations fitting in the clinic

ISRCTN ISRCTN69577753
DOI https://doi.org/10.1186/ISRCTN69577753
Secondary identifying numbers CV 17-20, OTGI 17-16
Submission date
21/01/2019
Registration date
23/01/2019
Last edited
15/04/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Multifocal contact lenses allow the wearers to see at all distances. For the best visual performance with multifocal contact lenses, typically one eye (the dominant one) will be fully corrected for distance vision and the other eye (non-dominant) will be biased towards intermediate and near vision. The aim of this study is to select the optimum lens power combinations for each eye to achieve the best distance and intermediate/near vision outcome with both eyes.

Who can participate?
Adults who are at least 40 years old and who have healthy eyes other than needing a near vision correction

What does the study involve?
Each participant has their eyes examined by the investigator and then fitted with two types of multifocal contact lenses according to their spectacle corrections and with additional plus or minus corrections in each eye. By reading letters of different sizes from various distances (far, intermediate and near), a series of vision measurements are taken with each of the pairs of multifocal contact lenses combination and corrections, and participant satisfaction is recorded on a 0-100 scale. All participants undergo the same series of vision tests and tasks.

What are the possible benefits and risks of participating?
Participants may not directly benefit from participation in this study. They may, however, contribute to research that may be used in the development of new, perhaps more successful, contact lenses. The examination and assessments are free and can be considered beneficial. All contact lenses have the potential of causing serious injury to the eye. Due to the nature and duration of the study the risks of participating in this study are considered to be similar to those of normal contact lens wear.

Where is the study run from?
Ocular Technology Group - International research clinic (UK)

When is the study starting and how long is it expected to run for?
March 2017 to December 2017

Who is funding the study?
CooperVision, Inc. (USA)

Who is the main contact?
Ms Trisha Patel

Contact information

Ms Trisha Patel
Public

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Study information

Study designSingle-center prospective randomized (testing order) double masked and non-dispensing study
Primary study designObservational
Secondary study designCase crossover study
Study setting(s)Other
Study typeScreening
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleMultifocal contact lens combinations fitting method optimization
Study objectivesThe study is an exploratory study so no formal hypothesis is being formulated for the purpose of sample size calculation.
Ethics approval(s)Yorkshire & The Humber - Bradford Leeds Research Ethics Committee Jarrow Business Centre Rolling Mill Road, Jarrow, NE32 3DT, Tel: +44 (0)207 104 8081, Email: nrescommittee.yorkandhumber-bradfordleeds@nhs.net, 04/04/2017, REC ref: 17/YH/0115, IRAS 225847
Health condition(s) or problem(s) studiedPresbyopia vision correction using multifocal contact lenses
InterventionMultifocal contact lens fitting for dominant and non dominant eye based on best sphere spectacle correction and over-refractions. Visual performance will be measured using letter charts and visual satisfaction with each contact lens combination will be recorded. This is a non-dispensing study involving 1 or 2 study visits (if a break is required). Participants will wear 2 multifocal contact lens types and power combination.
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureHigh contrast monocular and binocular visual acuities at distance (4 m), intermediate (67 cm) and near (40 cm) measured using letter charts in LogMAR during test visit
Secondary outcome measuresVisual satisfaction measured using visual analog scale (0-100) during test visit
Overall study start date13/03/2017
Completion date17/12/2017

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participantsUp to 75 participants
Key inclusion criteriaThere are no requirements as to participant race, gender or occupation.
In order to be enrolled, each participant shall meet the following criteria:
1. At least 40 years old
2. Have read and understood the Participant Information Sheet
3. Have read, signed and dated the Informed Consent
4. Current multifocal contact lens wearer
5. Spectacle refraction:
Distance:
Sphere: -6.00D to + 6.00D
Astigmatism: 0.00D to -0.75D
Near Addition:
Low Add: +0.75D to +1.25D
Mid Add: +1.50D & +1.75D
High Add: +2.00D to +2.50D
6. Best corrected visual acuity of at least 20/30 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 criteriaTo be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study.
The following are specific criteria that exclude a candidate from enrolment in this study:
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 contact 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
8. Participation in any clinical trial within 30 days of the enrolment visit
Date of first enrolment10/04/2017
Date of final enrolment01/06/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Ocular Technology Group - International
66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Sponsor information

CooperVision Inc. (USA)
Industry

6150 Stoneridge Mall Rd
Pleasanton
CA 94588
United States of America

Website http://coopervision.com

Funders

Funder type

Industry

CooperVision Inc. (USA)

No information available

Results and Publications

Intention to publish date30/06/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planSince this study is an exploratory investigation designed to evaluate different optical designs and fitting approaches for multifocal contact lenses, there are no specific plans for publication or dissemination of the study results; however, an abstract for submission to an ophthalmic conference may be generated in which case the ISRCTN registration number would be provided.
IPD sharing planThe 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 15/04/2020 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN69577753_Basic_Results.pdf
uploaded 15/04/2020

Editorial Notes

15/04/2020: The basic results of this trial have been uploaded as an additional file.