None listed
Conditions
Brief summary
The purpose of this study is to compare the accommodative and binocular function (defined by refractive measurements and binocular vision assessments) between dual focus, centre-distance multifocal, three different Extended Depth-of-Focus (EDOF) prototypes and single vision contact lenses. To achieve this, participants will wear the 6 lens designs separately during six short assessment visits. Outcomes will be accommodative responses in the form of accommodative lag/lead (measured in dioptres) and phoria measurements (measured in prism dioptres). Our hypotheses is that there will be no difference between lens designs for either outcomes.
Interventions
This is a prospective, single-masked, crossover, short-term clinical trial where participants will bilaterally wear for the duration of the visit, 2 commercially-available (and approved for use in Australia) and 3 prototype contact lenses used for myopia control and a single vision contact lens control (commercially-available and approved for use in Australia) with each lens to be worn at 6 different visits. There will be 7 scheduled visits for all participants.
The 6 lens types comprise:
• Com
This is a prospective, single-masked, crossover, short-term clinical trial where participants will bilaterally wear for the duration of the visit, 2 commercially-available (and approved for use in Australia) and 3 prototype contact lenses used for myopia control and a single vision contact lens control (commercially-available and approved for use in Australia) with each lens to be worn at 6 different visits. There will be 7 scheduled visits for all participants. The 6 lens types comprise: • Commercially available (Australia) myopia control lenses (MiSight™) manufactured by Coopervision and made from omafilcon A material; base curve 8.7 mm, power range: -0.75 to -6.00 D. • Commercially available (Australia) centre distance multifocal lenses (Proclear®) manufactured by Coopervision and made from omafilcon A material; base curve 8.7 mm, power range: -0.75 to -6.00 D, +2.00 add. • Three prototype extended-depth-of-focus contact lenses manufactured by Pegavision and made from etafilcon A; base curve 8.5 mm, power range -0.75 to -6.00 D. Each different extended-depth-of-focus lens has a different series of smooth, non-monotonic, aperiodic, power variation across the optic zone that was designed by enhancing multiple spherical aberration terms. • Commercially available (Australia) centre distance multifocal lenses (1 Day Acuvue® Moist) made from etafilcon A material; base curve 8.5 mm, power range: -0.75 to -6.00 D. Visits will be performed by unmasked investigators and comprise contact lens fitting, assessment of acuity, assessment of contact lenses on eye with a slit-lamp biomicroscope (a specialized microscope for viewing the eye) and assessment of accommodative-convergence responses. Each visit will be approximately 60 minutes in duration. Baseline visits will comprise auto-refraction, subjective refraction with visual acuity measurement and ocular assessment with a slit-lamp biomicroscope. Participants will wear their habitual vision correction in between wearing study lenses and a minimum of a night wash-out will be observed. All assessments will be carried out by an optometrist. Participants will be asked to remove and dispose of the lenses at the end of each visit. There will be a minimum of a one-night washout between study lenses.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. • Be between 18-40 years old, male or female. • Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator. • Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses. • Be myopic with less than or equal to 1.00 D of cylindrical power in either eye. • Be correctable to at least 0.20 logMAR in each eye with single vision contact lenses.
Exclusion criteria
• Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses. • Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. • Use of or a need for concurrent category S3 and above ocular medication at enrollment. • Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
Outcome results
None listed