How light scatter affects vision

Evaluation of Effect of Scatter on Visual Performance

We will test whether different levels of light scatter change vision in adults aged 18–69 who regularly wear soft contact lenses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry-sponsored)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT07443215 on ClinicalTrials.gov

What this trial studies

This single-site, randomized, single-masked, bilateral-wear crossover protocol involves three clinic visits to compare visual performance with different magnitudes of optical scatter. Participants will wear ACUVUE® OASYS 1-Day Sphere and ACUVUE® OASYS Multifocal in randomized sequences without dispensing lenses, while investigators remain masked to allocation. The study will measure objective and subjective vision outcomes under conditions that simulate increased scatter and will compare responses between younger non-presbyopic and older presbyopic adults. Results aim to detail how intrinsic ocular scatter and lens-induced scatter influence everyday visual clarity.

Who should consider this trial

Good fit: Adults 18–69 who habitually wear soft contact lenses at least 6 hours per day on at least 2 days per week, have distance refraction between +3.00 and −5.00 DS and less than 1.00 DC cylinder, possess usable spectacles, and can attend three clinic visits are ideal candidates.

Not a fit: People with extended-wear lenses, high astigmatism (≥1.00 DC), refractive errors outside the specified range, those who do not wear soft contact lenses regularly, or who cannot travel to Jacksonville are unlikely to receive benefit from participating.

Why it matters

Potential benefit: If successful, the findings could help eye care providers select or fit contact lenses that reduce the visual effects of scatter and improve clarity for different age groups.

How similar studies have performed: Prior research shows ocular scatter increases with age and can impair visual performance, but systematic manipulation of scatter using contact lens conditions across age groups is relatively under-studied.

Eligibility criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. Read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 69 years of age (inclusive) at the time of screening.
4. Habitually wear soft contact lenses (either spherical or multifocal) in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past 30 days.
5. Possess a wearable pair of spectacles that provide correction for distance vision.
6. Have the spherical component of their vertex-corrected distance refraction within the range +3.00 to -5.00 DS (inclusive) in both eyes.
7. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction below 1.00 DC in both eyes.
8. Have best corrected monocular distance VA of 20/25 or better in each eye.
9. Have Near Addition with Add refinement following BCC\<0.75D (Non-presbyopic group only).
10. Have Near Addition with Add refinement following BCC≥0.75D (Presbyopic group only).

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Be currently pregnant or lactating.
2. Be diabetic.
3. Be currently using any ocular medications or have an ocular infection of any type.
4. Have any ocular or systemic allergies, disease, infection, or use of medication that might contraindicate or interfere with contact lens wear or otherwise compromise study endpoints, including infectious diseases (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), or history of serious mental illness or seizures. See section 9.1 for additional details regarding systemic medications.
5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
6. Be currently wearing lenses in an extended wear modality.
7. Have a history of strabismus or amblyopia.
8. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
9. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
10. Have clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp findings (e.g. corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that may contraindicate contact lens wear or otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
12. Have had or have planned (within the study period) ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)

Where this trial is running

Jacksonville, Florida

• Vrc — Jacksonville, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Study Contact

Conditions Visual Acuity