Assessment of the Occuity PM1 Pachymeter

NCT05895617 | Completed

• 1 other identifier: ETH2021-1765
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma Eye

Keywords

Cornea; Ocular; Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 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.

  upto 3 months

Study Arms (1)

Research Study

Is the Occuity pachymeter non inferior in it's measurement of central corneal thickness compared to the ultrasound pachymeter, Lenstar and Pentacam.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

United Kingdom

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Occuity Limited: lead
• City, University of London: collaborator
• Moorfields Eye Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Occuity Limited

Reading, Berkshire, RG1 3BE, United Kingdom

Location

MeSH Terms

Conditions

Corneal Diseases; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases; Ocular Hypertension

Study Officials

• Lawrenson, Professor

  City, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 8, 2023
• Study Start: January 15, 2023
• Primary Completion: February 22, 2023
• Study Completion: April 19, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Draft copy is available now 19-APR-2023 and is under formal review

Locations

GB (1)