iCare HOME2 Clinical Trial

NCT05162989 | Completed FDA Device

• 1 other identifier: TA023-207
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical study is to provide information about the variability of the intraocular pressure (IOP) self-measurements with the iCare HOME2 tonometer in comparison to the variability of the IOP measurements with the reference tonometer (iCare IC200), over a wide range of IOP values.

Conditions

Intraocular Pressure; Glaucoma

Outcome Measures

Primary Outcomes (1)

• Repeatability of IOP measurements

  Repeatability of IOP measurements comparison of iCare HOME2 vs iCare IC200

  Through study completion, an average of 1-2 months

Study Arms (1)

iCare HOME2 vs iCare IC200

EXPERIMENTAL

Measurement of intraocular pressure (IOP) with iCare IC200 reference tonometer compared to iCare HOME2 test tonometer. Measurement will be performed to categorize each subject as having Low IOP (7 to 16 mmHg), Medium IOP (\>16 to \<23 mmHg), or High IOP (≥23 mmHg).

Device: iCare HOME2 vs iCare IC200

Interventions

iCare HOME2 vs iCare IC200 DEVICE

Measurement of IOP with iCare HOME2 compared with iCare IC200.

iCare HOME2 vs iCare IC200

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Glaucoma patients having confirmed optic nerve damage with visual field defects consistent with the glaucomatous optic neuropathy or
• Glaucoma-suspects being followed because of elevated IOP, and/or because of other risk factors for developing glaucoma or optic nerve damage.

You may not qualify if:

• Active ocular infection (e.g., pink eye or infectious conjunctivitis)
• Recent trauma to the eye including corneal laceration or corneal/scleral perforation
• Disabling arthritis or difficulty handling the tonometer
• Severe difficulty in opening the eyes including abnormal contractions or twitches of the eyelid (blepharospasm)
• Involuntary, rapid, and repetitive eye movements (nystagmus)
• Low uncorrected near visual acuity of 20/200 or below
• Significant glaucomatous central field loss
• Only one functional eye
• Poor or off-center visual fixation
• Poor hearing and/or communicates using sign language
• Keratoconus (or other corneal disorder)
• Congenitally small eye (microphthalmos)
• Enlarged eyeball from the childhood glaucoma (buphthalmos)
• Previous experience using or interacting with the HOME tonometer during usability tests or clinical trials
• Any affiliation with Icare and its employees

Sponsors & Collaborators

• Icare Finland Oy: lead

Study Sites (1)

East West Eye Institute

Los Angeles, California, 90013, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Michelle A Sato, MD

  East West Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigator cannot see both the test device and reference device measurement results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: December 20, 2021
• Study Start: November 26, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)