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Clinical Investigation of Eye C Better's Photobionic Intraocular Pressure Biomonitor Tonometer

NCT07762053

Active Not RecruitingNA

Sponsor: EyeCBetter Corporation

Conditions: Elevated Intraocular Pressure (IOP)

Interventions: Photobionic IOP Tonometer (PIB)

Countries: United States

The device being studied in this research is the investigational PIB, a tool designed to measure eye pressure without touching the eye. The device uses a very low-power, eye-safe infrared light and a gentle sound signal to detect tiny movements on the white part of the eye. A camera records these movements, and a computer analyzes the information to estimate eye pressure. The test takes only a few seconds and does not require eye drops or contact with the eye. The device rests near your face using a chin and forehead support, like equipment used in an eye doctor's office. The PIB aims to provide the following possible benefits over the devices doctors may be using now including the GAT: * No touching of the eye to lower the risk of infection and discomfort * Improved accuracy and precision * Faster eye pressure measurements * Measurements that may be done by a patient at home without the need for a doctor * A low-cost eye pressure measurement device that may be used in areas where there are fewer doctors The PIB device is investigational, which means that it is not approved by the Food and Drug Administration (FDA). The GAT device has been approved by the FDA.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Subject is a female or male;
2. Subject is with or without a prior glaucoma diagnosis;
3. Subject is 18 years or older;
4. Subject is willing and able to sign an informed consent;
5. Subjects considered to be vulnerable (i.e. individuals with impaired consent capacity and/or lack or loss of autonomy on the condition that written consent is provided by a legally authorized representative.

Exclusion Criteria:

1. Subjects who are prisoners
2. Subject refuses or is unable to sign the informed consent;
3. Subjects with only one functional eye;
4. Those with poor or eccentric fixation in one or both eyes;
5. Those with corneal scarring or who have had corneal surgery including corneal laser surgery;
6. Those with a history of incisional glaucoma or incisional retinal surgery;
7. Microphthalmos;
8. Buphthalmos;
9. Contact lens use within the last three months;
10. Symptoms of Dry Eye Syndrome and signs of dry eye on examination of cornea;
11. Known history of difficulty in obtaining GAT IOP measurements;
12. Lid squeezers or blepharospasm;
13. Nystagmus;
14. Keratoconus;
15. Any corneal or conjunctival pathology or infection;
16. Any conjunctival thickening or opacification that reduces the clear view to the sclera;
17. Central corneal thickness greater than 0.600 mm or less than 0.500 mm (2 standard deviations about the human mean);
18. Cataract Extraction within the last three months.

Locations (1)

La Quinta, California, United States