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Assessment of the Occuity PM1 Pachymeter

Sponsored by Occuity Limited

About this trial

Last updated 2 years ago

Study ID

ETH2021-1765

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

To determine whether the Occuity PM1 device is non-inferior in measuring central corneal thickness when compared to ultrasound pachymetry, the Lenstar and the Pentacam. The Investigation aims to assess long-term safety of the Occuity PM1 device when used under the conditions and for the purposes intended, to ensure it will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons. The central corneal thickness measurements taken by the three devices: Occuity PM1, the ultrasound pachymeter and Lenstar. Demonstrating that the Occuity PM1 Pachymeter is not inferior to the LenStar in terms of equivalency to a 95% confidence level using the Bland Altmen equation/approach based on +/-20micron equivalency. The investigators would like to measure the thickness of the cornea, which is the clear window at the front of the eye. A corneal thickness measurement is important for several reasons. The measurement can tell an eye care professional if the cornea is swollen, which may mean the particiapnt have an increase in fluid within the cornea. Also, assessing corneal thickness can help in the diagnosis of glaucoma and the measurement is important if the participant is going to have eye surgery. The instruments that are currently in use are usually very large and quite expensive and therefore not ideal for use as part of routine eye care. Some instruments require contact with the surface of the eye, which may be uncomfortable. Occuity Ltd. is a medical device company based in Reading, which has been investigating this. They have developed a new instrument (called the 'PM1 Pachymeter') for measuring the thickness of the cornea. The instrument shines a harmless low power beam into the eye and then measures the light reflected back from the eye in order to check the thickness of the cornea. The low power beam is not a visible light and so the participant will not be able to see it. s study will assess how closely the eye measurements taken from the new PM1 Pachymeter matches eye measurements taken from two other devices that are currently on the market. The goal is to provide a non-contact, hand-held meter that is fast and easy to use without the need to contact the eye.

What are the participation requirements?

Yes

Inclusion Criteria

The participant must meet ALL the following criteria to be considered eligible for the study: - Male or Female, aged 18 years or above. - Participant is willing and able to give informed consent for participation in the study. - Able and willing to comply with all study requirements.

No

Exclusion Criteria

The participant may not enter the study if ANY of the following apply: - Any ocular surgery within 6 months - Known active corneal abnormalities (e.g. Keratoconus, epithelial defects) - Previous corrective refractive surgery (e.g. LASIK, PRK) - Current ocular inflammatory or infectious disease (e.g. Uveitis, keratitis, corneal ulcers) - Contact lens use within the last week - Any contraindications to use of topical anaesthetic eye drops - Any other pathology which the clinician or investigator believe may affect the accuracy of the CCT measurement

Locations

Location

Status