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Exploratory study of 24-hour intraocular pressure fluctuation profile in patients with primary open-angle glaucoma and healthy subjects with contact lens sensor

Exploratory study of 24-hour intraocular pressure fluctuation profile in patients with primary open-angle glaucoma and healthy subjects with contact lens sensor

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042230066
Enrollment
150
Registered
2023-08-04
Start date
2023-11-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma (POAG) Primary Open Angle Glaucoma (POAG)

Interventions

Triggerfish will be placed in eyes with advanced visual field defects and IOP fluctuations will be recorded for 24 consecutive hours to predict the visual field progression. In untreated POAG patients

Sponsors

Higashide Tomomi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Subjects of male or female over 20 to 79 years old 2)Patients with primary open-angle glaucoma who have been followed up for 2 years or more at the medical in-stitution, or patients who have been diagnosed with primary open-angle glaucoma for the first time, or healthy subjects who have no findings suggesting glaucoma and have no other eye disease. 3)Signed informed consent for the investigation

Exclusion criteria

Exclusion criteria: 1) Patients with a static visual field testing (HFA 30-2 or 24-2 program) MD value of -12.0 dB or less in the study eye 2) The spherical diopter of the inspected eye is plus minus 6.00D, and the cylinder diopter is out of the range of plus minus 3.00D 3) In addition to glaucoma, existence with another eye diseases that affect the results of visual field testing and three-dimensional fundus image analysis using optical coherence tomography in the study eye 4) Glaucoma surgery, glaucoma laser treatment, refractive surgery within 6 months before the start of the study 5) Allergy to corneal anesthetic 6) Patients with implanted cardiac pacemakers or other electro-medical devices 7) Patients with eye infections 8) Patients with acute and subacute inflammation of the anterior segment of the eye 9) Patients with corneal, conjunctival, or eyelid abnormalities,corneal hypoesthesia, lacrimal insufficiency, or tear secretion insufficiency, or lacrimal disease to the extent that it affects the use of the sensor. 10) Patients with a history of complications related to contact lens wear 11) Patients with allergic diseases to silicone materials 12) Any person who is in an environment where the sensor is contaminated by spray, smoke, dust, steam, etc. 13) Patients with complications such as serious cardiac, hepatic, renal, pulmonary, or hematological diseases that are considered unsuitable for clinical research. (14) Those who have participated in other clinical research or clinical trials (including those outside the field of ophthalmology) within the past six months. (15) Any other person whom the principal investigator or subphysician determines to be unsuitable for the subject, or who the principal investigator or sub-physician determines to be unsuitable for wearing contact lenses

Design outcomes

Primary

MeasureTime frame
Obtain 24-hour IOP fluctuation pattern and various profile parameters (Acrophase, Amplitude, Bathyphase etc.)

Secondary

MeasureTime frame
Evaluation for visual acuity test, slit lamp microscopy, intraocular pressure and adverse events

Contacts

Public ContactTomomi Higashide

Kanazawa University Hospital

eyetomo@med.kanazawa-u.ac.jp+81-76-265-2403

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026