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iCare ST500 Clinical Trial

Sponsor
Icare Finland Oy (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05742009
Collaborator
(none)
150
Enrollment
1
Arm
4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Clinical validation of iCare ST500 tonometer per ANSI Z80.10:2014 standard

Condition or Disease Intervention/Treatment Phase
  • Device: iCare ST500
  • Device: GAT
  • Device: iCare IC200
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Investigator cannot see the measurement results.
Primary Purpose:
Diagnostic
Official Title:
Clinical Validation of a Slit Lamp Mounted Rebound Tonometer
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: iCare ST500 vs GAT and iCare IC200

Measurement of intraocular pressure (IOP) with iCare ST500 compared to GAT and iCare IC200. Measurements will be performed in three categories: Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (≥23 mmHg).

Device: iCare ST500
Measurement of Intraocular Pressure (IOP)

Device: GAT
Measurement of Intraocular Pressure (IOP)

Device: iCare IC200
Measurement of Intraocular Pressure (IOP)

Outcome Measures

Primary Outcome Measures

  1. Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers [Through study completion, an average of 4 months]

    Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients at least 18 years old
Exclusion Criteria:

  1. Subjects with only one functional eye

  2. Subjects having poor or eccentric fixation in the study eye(s)

  3. High corneal astigmatism >3D in the study eye(s)

  4. Central corneal scarring

  5. History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)

  6. Microphthalmos

  7. Buphthalmos

  8. Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally

  9. Dry eyes (clinically significant)

  10. Lid squeezers - blepharospasm

  11. Nystagmus

  12. Keratoconus

  13. Any other corneal or conjunctival pathology or infection relevant to this study

  14. Central corneal thickness greater than 600 μm or less than 500 μm in the study eye(s)

  15. Cataract Extraction within last 2 months in the study eye(s)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Icare Finland Oy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Icare Finland Oy
ClinicalTrials.gov Identifier:
NCT05742009
Other Study ID Numbers:
  • TA04-185
First Posted:
Feb 23, 2023
Last Update Posted:
Feb 23, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 23, 2023