None listed
Conditions
Brief summary
The research questions this project seeks to answer are whether the optical power designs developed by Johnson and Johnson Vision Care (JJVC) for use in contact lenses have the ability to shorten the eye and how much those same designs affect vision levels. This will be a prospective, interventional data collection study comparing the relative effectiveness of the various designs that are tested. It is hypothesized that by varying the optical design and the amount of blur imposed on the eye, small temporary changes in the length of the eye can be measured. Short-term changes in eye length (30 minutes) are thought to be a biomarker for the longer-term growth of the eye and can therefore be used as a predictive tool for whether the specific design will slow or increase myopia progression in longer term clinical trials (over years).
Interventions
The eye rapidly responds to imposed blur by changing choroidal thickness (a vascular layer at the back of the eye) and eye length (choroidal thickness changes move the retina forward and backward to influence eye length). Such changes in eye length vary according to the magnitude, type and location of the imposed blur (ie. the optical design). These changes in choroidal thickness and eye length are very small (typically 5-15 microns) compared to the length of the eye (23 mm) and have no measurab
The eye rapidly responds to imposed blur by changing choroidal thickness (a vascular layer at the back of the eye) and eye length (choroidal thickness changes move the retina forward and backward to influence eye length). Such changes in eye length vary according to the magnitude, type and location of the imposed blur (ie. the optical design). These changes in choroidal thickness and eye length are very small (typically 5-15 microns) compared to the length of the eye (23 mm) and have no measurable impact on vision. This study involves the use of adaptive optics (digital optics) to create optical designs for participants to view a movie on a small TV screen. Measurements of eye length are taken before and after 30 minutes of viewing a movie on the screen with each of the tested optical designs (measured on different days). The small temporary changes in eye length in response to the optical designs are thought to be predictive of longer-term eye growth (over years). The quality of vision is also tested through the adaptive optics system with each optical design. Eight optical designs will be tested, each on a separate day (to avoid carry-over effects) and at the same time of day (to avoid diurnal effects). The eight optical designs are: (1) +3 D defocus, (2) central +7 D defocus and a non-coaxial peripheral zone crossing the optical axis, (3) a high order oscillation in power from plano to +4 D, (4) a high order oscillation in power from plano to +6 D, (5) a high order oscillation in power from plano to +8 D, (6) a saw-tooth oscillation in power from plano to +4 D and (7) a saw-tooth oscillation in power from plano to +6 D and a control condition (8) with clear vision (no optical blur). Repeated measures study design with all participants being tested with all optical designs. The participant views movies of their choice on a black and white high-definition micro-display screen through the adaptive optics system. Participants sit in a head rest (chin and forehead rest) during the experiment viewing through the adaptive optics system. The movie displayed on the micro-display is projected through the adaptive optics system and subtends a visual angle of about 6 degrees, which means that its size is similar to a mobile phone at arm's length. The research scientist monitors the participants alignment in the adaptive optics system periodically throughout the 30 minutes of movie viewing to ensure alignment of the optics with the participants pupil (optical aperture of the eye).
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
Participants will be recruited who meet the following inclusion criteria: 1. Subjects must read, understand and sign the informed consent form 2. Subjects must be between 18 and 39 years (inclusive) of age to ensure active and sustained accommodation response 3. Best corrected visual acuity of at least 0 logMAR in each eye 4. No significant ocular disease or functional vision loss (e.g. peripheral visual field defect) 5. Astigmatism of 0.50 DC or less to eliminate the need for astigmatic correction during the experiment 6. Best sphere refractive error between 0.00 and -5.00 DS 7. Steady and accurate fixation (no significant eye movement anomalies).
Exclusion criteria
Exclusion Criteria after Screening: 1. Currently pregnant 2. Any systemic disease (e.g., Sjögren’s Syndrome), significant allergies, infectious disease (e.g., hepatitis, tuberculosis), COVID-19, or other diseases, by subject’s self-report, which are known to potentially interfere with participation in the study. 3. Use of systemic medications (e.g., chronic steroid use) that are known to have side effects in eyes or vision and/or interfere with participation in the study. 4. Any current use of ocular medication. 5. Recent temporary or long-term use (within 21 days from enrolment) of topical agents with anti-muscarinic properties. This includes but is not limited to scopolamine, pirenzepine, tropicamide, cyclopentolate, atropine and homatropine (anti-muscarinics can cause the choroid to thicken). 6. Any planned (during the course of the study) ocular surgery (e.g., LASIK). 7. History of myopia control treatment or participation in any prior myopia control clinical study with an optical intervention for more than 2 weeks. This includes but is not limited to orthokeratology treatment or use of other ophthalmic devices (e.g., bifocal, multifocal spectacles/contact lenses or other novel contact or spectacles lenses). This also includes light therapy for myopia control such as red or blue light. 8. No regular use of nicotine (cigarettes, vapes, patches etc). 9. No alcohol or caffeine intake within 2 hrs prior to a testing session.
Outcome results
None listed