EyeQue VisionCheck 510(k) Clinical Trial

Launched by EYEQUE CORP. · Sep 6, 2023

Keywords

ClinConnect Summary

The EyeQue VisionCheck 510(k) Clinical Trial is studying a new device designed to measure vision problems like nearsightedness, farsightedness, and astigmatism. The goal is to see if the measurements taken by this device are similar to those taken by a traditional eye exam tool called a phoropter, which is used by eye doctors. This study is not yet recruiting participants, but it will be open to individuals aged 65 to 74 who can use a smartphone and are interested in getting their vision checked.

To join the study, participants must be able to understand English, give consent, and follow the study's instructions. However, some people may not be eligible, such as those with severe vision problems, certain eye conditions, or neurological issues. Participants can expect to use the EyeQue device and app to measure their vision in a comfortable setting. This research is important because if successful, it could help provide a more accessible way for people to check their vision at home.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Each participant must meet the following criteria to be enrolled in this study:
• • 1. Participant or legally authorized representative (LAR) is willing and able to give informed consent
• • 2. Participant is willing and able to follow all study procedures and requirements
• • 3. Participant is able to use a smartphone
• • 4. Participant is interested in getting refraction correction measurement
• • 5. Participant is able to speak, read and write English fluently
• Exclusion Criteria:
• Participants who meet any of the following criteria will be excluded from the study:
• • 1. Spherical correction \>+8D or \<-10D (outside the range of the VisionCheck measurement)
• • 2. Astigmatism correction of less than -5D (optometric notation, outside the range of the VisionCheck measurement)
• • 3. Inability to see the red and green lines (may be overlapped to form a, partially, yellow line) through the VisionCheck device
• • 4. Participant does not have the physical dexterity to properly operate the EyeQue VisionCheck device or the EyeQue app on the smartphone in the Investigator's opinion
• • 5. Has initiated any new medication in the two weeks prior to enrolling in this study that, in the best medical judgment of the Investigator, would impact their participation in the study or ability to use the EyeQue VisionCheck device
• • 6. Eye surgery within 12 months prior to enrolling in this study (including Lasik or lens replacement)
• • 7. Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect vision within the greater of three days or five half-lives prior to enrolling in this study
• • 8. Using an investigational drug or approved therapy for investigational use within the greater of three days or five half-lives prior to enrolling in this study
• • 9. Color deficiency (Ishihara pseudoisochromatic plates: Concise 14-plate edition: six or more errors on plates 1-11; the 24-plate edition: seven or more errors on plates 1-15; the 38-plate edition: nine or more errors on plates 1-21)
• • 10. Neurological and developmental conditions that may affect the outcome of the trial including, but not limited to, Multiple Sclerosis (MS), Stroke, Traumatic Brain Injury (TBI), Parkinson's Disease, Alzheimer's Disease, Dementia, Migraines, Optic Neuropathies, Brain Tumors, Hereditary Conditions (such as Leber's hereditary optic neuropathy (LHON) or retinitis pigmentosa), Epilepsy, Diplopia. Investigator discretion shall be applied to any additional conditions not listed.
• 11. Eye pathologies, including but not limited to:
• • 1. Glaucoma
• • 2. Any macular disease including macular degeneration, macular hole, macular dystrophy, epiretinal membrane, retinal vein occlusion, macular telangiectasia, central serous chorioretinopathy and cystoid macular edema
• • 3. Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis, ocular histoplasmosis syndrome)
• • 4. Keratoconus
• • 5. Diabetic neuropathy/retinopathy
• • 6. Cytomegalovirus retinitis
• • 7. Diabetic macular edema (evidence of fluid)
• • 8. Retinitis pigmentosa
• • 9. Amblyopia (best corrected visual acuity \[BCVA\] ≥ 20/30)
• • 10. Chronic or acute uveitis (cells and/or flare in the anterior chamber)
• • 11. Strabismus (manifest/latent, exotropia, esotropia, hypertropia, exophoria, and esophoria)
• • 12. Abnormal astigmatism (mild to severe, \> 4D)
• • 13. Binocular vision anomalies
• • 14. Chronic dry eye
• • 15. Monovision