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iCare ST500 Clinical Trial

I

Icare

Status

Completed

Conditions

Intraocular Pressure

Treatments

Device: iCare IC200
Device: iCare ST500
Device: GAT

Study type

Interventional

Funder types

Industry

Identifiers

NCT05742009
TA04-185

Details and patient eligibility

About

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

Enrollment

165 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

165 participants in 1 patient group

iCare ST500 vs GAT and iCare IC200
Experimental group
Description:
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).
Treatment:
Device: GAT
Device: iCare IC200
Device: iCare ST500

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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