Choroidal thickness change after 1 hour wearing prototype soft contact lenses

Measuring Changes In Choroidal Thickness Induced By Prototype Soft Contact Lenses Worn For 1 Hour

This test will see if three prototype soft contact lenses change choroidal thickness in people aged 18 to 25 with myopia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 25 Years
• Sex: All
• Sponsor: Myoptechs, Inc (Industry-sponsored)
• Locations: 1 site (Waterloo, Ontario)
• Trial ID: NCT07155551 on ClinicalTrials.gov

What this trial studies

Adults aged 18–25 with low to moderate myopia will wear three different prototype soft contact lenses, each for one hour, with measurements taken around the wear period. Eye imaging will be used to measure short-term changes in choroidal thickness under controlled conditions (for example, avoiding caffeine, alcohol, smoking, or cannabis before visits). The study excludes people who have used myopia-control treatments in the prior two years and favors participants with prior soft contact lens experience. Results are intended to identify immediate optical effects on the choroid that could inform future contact lens designs.

Who should consider this trial

Good fit: Ideal candidates are 18–25 years old, have myopia between −0.50 and −4.50 diopters in both eyes, and have prior experience with soft contact lenses and the ability to follow visit instructions.

Not a fit: People outside the 18–25 age range, with high myopia beyond the specified range, currently using myopia-control treatments, or unable to wear soft contact lenses are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could help guide the design of contact lenses intended to influence eye structure in ways that may slow myopia progression.

How similar studies have performed: Previous optical-intervention studies have shown that some lenses and vision changes can alter choroidal thickness and relate to myopia control, but testing prototype soft lenses for immediate one-hour effects remains an area of active exploration.

Eligibility criteria

Inclusion Criteria:

* Are 18-25 years of age (inclusive) and have full legal capacity to volunteer; Have read (or be read to) and signed the information and consent form; Habitually wear soft contact lenses or are spectacle wearers with previous experience of soft contact lens wear;
* Are myopic with both eyes having a vertex corrected spherical equivalent non-cycloplegic refraction of at least -0.50 DS and no more than -4.50 DS;
* Achieve at least LogMAR +0.10 with spherical equivalent refraction in each eye;
* Are willing and able to maintain the appointment schedule and follow the measurement visit instructions which include no use of caffeine drinks, alcohol or other stimulants 12 hours before each measurement visit and no smoking or use of recreational cannabis 24 hours before the study visit;
* Have not used a myopia control treatment within 2 years prior to Visit 0 (this includes multifocal spectacle or contact lens wear, orthokeratology, or atropine);
* Typically sleeps at least 7 hours per night.

Exclusion Criteria:

* Participating in any concurrent clinical or research study;
* Have astigmatism of more than 1.00 DC in either eye as per non-cycloplegic refraction;
* Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
* Have any known active\* ocular disease and/or infection;
* Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism, and active allergies;
* Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include antihistamine, atropine eye drops;
* Have known sensitivity to the sodium fluorescein diagnostic pharmaceutical to be used in the study;
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
* Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
* Are an employee of the Centre for Ocular Research \& Education directly involved in this study (i.e. on the delegation log).

Where this trial is running

Waterloo, Ontario

• Centre for Ocular Research and Education at the School of Optometry and Vision Science at Waterloo University — Waterloo, Ontario, Canada (Recruiting)

Conditions Myopia; Refractive Error