None listed
Conditions
Brief summary
A prospective, non-dispensing study to assess the objective and subjective visual performance of ophthalmic prototypes. Up to 150 participants to be enrolled in the study, with a minimum of 10 participants included in the assessment of each prototype. The prototypes will be worn monocularly or binocularly, over the eye/s with best subjective vision with habitual correction or best-corrected subjective refraction, for a minimum of 20 minutes. In monocular measures, the non-measuring eye will be occluded during testing. Measures of visual acuity thresholds, visual function, and subjective vision gradings will be taken while wearing the prototypes. Each individual participant may test multiple prototypes and may test multiple prototypes at each study visit. All participants will undergo evaluation wearing relevant active and/or passive controls at the study visit.
Interventions
Prototypes will be worn monocularly or binocularly, over the eye/s with best subjective vision with the habitual correction or best-corrected subjective refraction performed by an optometrist, for a minimum of 20 minutes. Participants may be asked to wear up to 3 prototypes during each visit. The total duration of the study visit is up to 90 minutes. Each participant may be asked to wear a minimum of 6 and a maximum of 30 prototypes. Participants will need to attend a minimum of two study visits
Prototypes will be worn monocularly or binocularly, over the eye/s with best subjective vision with the habitual correction or best-corrected subjective refraction performed by an optometrist, for a minimum of 20 minutes. Participants may be asked to wear up to 3 prototypes during each visit. The total duration of the study visit is up to 90 minutes. Each participant may be asked to wear a minimum of 6 and a maximum of 30 prototypes. Participants will need to attend a minimum of two study visits in order to test the minimum of 6 prototype lenses, or at least 10 visits if they choose to test all 30 prototypes. The commercially available control lenses are: - Active control 1: Miyosmart manufactured by Hoya, Japan; - Active control 2: Stellest manufactured by Essilor, France; - Passive control: Single vision lens. The prototype lenses all have a similar central optical design to the active controls to correct the refractive error, however, their peripheral optical designs all differ in refractive power to the controls.
Sponsors
Brien holden vision institute limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. Be 18years and above. - Willing to comply with the wearing of the study lenses and the clinical trial visit schedule as directed by the Investigator. - Have ocular health findings considered to be “normal” - Spherical prescription range of +6.00D to -6.00DS inclusive and astigmatism <-2.00DC.Reading add power of <+3.00D - Vision of 6/7.5 (20/25) or better in each eye with or without correction. - Spectacle and/or contact lens wearers or participants not requiring any optical correction.
Exclusion criteria
- Have strabismus and/or amblyopia. - 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. - Any systemic disease that adversely affects ocular health e.g. diabetes, Graves’ disease, and autoimmune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogren’s syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. - Eye surgery within 12 weeks immediately prior to enrolment for this trial. - Previous corneal refractive surgery. - Known allergy or intolerance to ingredients in any of the clinical trial products. - Pregnancy*. The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
Outcome results
None listed