Instructions for use

Device

OculiRX. Software-only distance visual-acuity screening instrument — measures and reports a per-eye acuity value (logMAR/Snellen) for provider review.

Software version 0.0.0. Manufactured by Centaris Health Inc., 15021 Seven L Trail, Helotes, TX 78023. Contact ryan@oculirx.com.

Indications for use

OculiRX is indicated for the screening measurement of visual acuity (monocular and binocular) in adults aged 22–40, self-administered under the supervision of a licensed eye-care professional who reviews every result, for eyeglass or contact-lens prescription renewal or monitoring between in-office exams. It reports a measured per-eye acuity value (logMAR/Snellen) as a screening-grade record only.

This software version measures each eye separately (right eye, then left eye). It does not yet measure both eyes together.

Eligible ages: 22 to 40.

Prescription use

Prescription use only (Rx). Federal law restricts this device to use by or on the order of a licensed eye-care provider. Access is gated by a provider-issued credential.

What OculiRX is not

OculiRX:

• does not diagnose any condition
• does not replace a comprehensive eye exam
• does not render a clinical decision
• does not measure refractive error, color vision, depth perception, contrast sensitivity, or visual field
• does not generate eyeglass or contact-lens prescriptions

Contraindications

Do not use OculiRX if any of these apply to you:

• I have nystagmus or other abnormal eye movements (e.g. cranial-nerve palsy).
• I have a cognitive impairment that would affect my ability to take this test.
• I currently have sudden vision loss, eye pain, new floaters or flashes, or recent eye trauma.
• I am being monitored for or evaluated for a condition that needs a comprehensive eye exam (suspected retinal detachment, glaucoma, diabetic retinopathy, or post-operative follow-up).

Warnings

• This is a screening test only. Your result is NOT a diagnosis and MUST be reviewed by a licensed eye-care provider before any decision is made.
• Do not use this test if you have sudden vision loss, eye pain, new floaters or flashes, or recent eye trauma — seek in-person care immediately.
• Do not use this test if you have nystagmus, abnormal eye movements, or a condition requiring a comprehensive eye exam (e.g. suspected retinal detachment, glaucoma evaluation, diabetic retinopathy monitoring, post-operative follow-up).
• Screen calibration with a standard card is required at the start of every session — the test cannot proceed without it.
• A working front-facing webcam is required throughout. Keep your face visible to the camera for the entire test; looking away or covering your face will pause the test.
• Maintain the on-screen target viewing distance (about 50 cm) for the whole test. If you move out of range the test will pause.
• Test each eye separately exactly as instructed, fully covering the other eye with an opaque occluder when prompted. Do not guess by peeking.

Precautions

• Calibration is required each session and is valid for 24 hours.
• A front-facing webcam (≥720p) is required; ensure good, even lighting and no glare on the screen.
• Keep your face visible to the webcam at all times during the test.

Regulatory status

Regulatory status. OculiRX is not FDA-cleared. It is the same device type as the FDA-cleared Visibly Digital Acuity Product (Class I, product code QTO, 21 CFR 886.1150), a 510(k)-exempt device type. Centaris Health Inc. has asked FDA, through Q-Submission Q261815, whether that exemption applies to OculiRX or a Traditional 510(k) is required; that feedback is pending. OculiRX is a screening-grade acuity measurement; it does not perform refraction, diagnose disease, or generate eyeglass or contact-lens prescriptions.

Contact

Centaris Health Inc., 15021 Seven L Trail, Helotes, TX 78023. Email privacy@oculirx.com.