NCT05147610

Brief Summary

In adult patients, intraocular pression readings are often taken with an air puff tonometer or goldmann tonometer. The current gold standard for IOP measurement is the Goldmann Applanation Tonometry (GAT). In some patients, measurement of intraocular pressure taken by applanation or by air puff may prove to be impossible for various reasons (obesity, handicap, mental disorder, blindness for Air Puff Tonometry, Anxiety, etc). There are also many other devices that can be used to measure IOP, including those using rebound tonometry like the Icare 200. The rebound tonometer would systematize IOP screening because of its ease of use, provided its measurements are reliable. In this prospective study, investigators will be measuring participant's IOP with Goldmann Applanation Tonometry, Icare 200 Tonometer and Air Puff Tonometry to see if there is an agreement in IOP between the different devices. Investigators will also look if there is a concordance between central corneal thickness and IOP. Moreover, investigators will look if there is a IOP concordance between the 3 different devices for hight BMI people. Indeed, higher body mass index tend to have difficulties with proper positioning at the slit lamp that may lead to inaccurate GAT measurements. Additionally, stress level of the patients with different tonometry devices will be recorded using a visual analog scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

November 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

November 29, 2021

Last Update Submit

July 21, 2022

Conditions

Glaucoma Eye

Keywords

Air puff tonometerGoldmann tonometerApplanation tonometerRebound tonometerIcare 200Comparative studyIntraocular pression

Outcome Measures

Primary Outcomes (1)

  • mean difference (mmHg) between the Icare200 rebound tonometer and the Goldmann applanation tonometer

    To evaluate the concordance of Goldmann tonometer and Icare 200 tonometer

    Day 0

Secondary Outcomes (4)

  • Diagnostic Performance

    Day 0

  • Correlation between central corneal thickness and IOP

    Day 0

  • Effect of BMI on IOP

    Day 0

  • Patient comfort during tonometry

    Day 0

Study Arms (1)

patients requiring an IOP (intra-Ocular Pression) measurement

EXPERIMENTAL

group representing adults patients in ophthalmologic consultation requiring an IOP measurement

Diagnostic Test: Intraocular pression

Interventions

Intraocular pressionDIAGNOSTIC_TEST

First, measurement of the eye pressure by air-puff tonometry and estimation of the pachymetries with the TONOREF III. Secondly, measurement of the eye pressure by GAT. Thirdly, measurement of the eye pressure by Icare 200.

patients requiring an IOP (intra-Ocular Pression) measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult man ou woman who consults in ophthalmology for a reason justifying an IOP measurement
  • Able to give informed consent
  • Being affiliated with a social security system

You may not qualify if:

  • Participants who are unable to have IOP measured by Goldmann Tonometry
  • Participants who are unable to have IOP measured by air puff Tonometry
  • Age younger than 18 years
  • Inability to sit
  • Corneal ulcer
  • Refractive surgery
  • Corneal Astigmatism \>3D
  • Participants who wear contact lenses
  • Pregnancy
  • Unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Study Officials

  • Adrien Coutu

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: all participants receive the same intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 7, 2021

Study Start

December 1, 2021

Primary Completion

April 22, 2022

Study Completion

July 21, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Locations

FR(1)