NCT06247072

Brief Summary

To collect measurements of a new tonometer and show conformance to standards for tonometers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

February 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

January 30, 2024

Last Update Submit

April 4, 2024

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • IOP

    pressure inside the eye

    1 day

Study Arms (3)

low IOP

having low IOP in one eye

Device: Tonometer

intermediate IOP

having intermediate IOP in one eye

Device: Tonometer

high IOP

having high IOP in one eye

Device: Tonometer

Interventions

TonometerDEVICE

measures IOP

high IOPintermediate IOPlow IOP

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eyes with different range of IOP

You may qualify if:

  • Age at least 22 years at the time of the informed consent
  • Provide voluntary written consent for participation in the study

You may not qualify if:

  • Have only one functional eye
  • Have difficulty in ocular fixation or eccentric fixation in either eye
  • Have corneal scar or have a history of corneal surgery such as corneal laser surgery (cataract surgery is acceptable)
  • Have microphthalmia
  • Have buphthalmos
  • Wear contact lens (have used soft contact lenses within the last 3 months and/or hard contact lenses within the last 6 months)
  • Have dry eyes and taking prescription medication or using artificial tears daily
  • Have blepharospasm
  • Have nystagmus
  • Have keratoconus
  • Have corneal or conjunctival lesions or infections
  • Have a central corneal thickness of \<500μm or \>600μm
  • Have corneal astigmatism \>3D
  • Have known allergy to ophthalmic anesthetics
  • Have known allergy to sodium fluorescein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New View Optometric Center

La Mesa, California, 91942, United States

Location

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

February 2, 2024

Primary Completion

April 4, 2024

Study Completion

April 4, 2024

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)