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

JRCT ID: jRCTs042230066

Registered date:04/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary Open Angle Glaucoma (POAG)
• Date of first enrollment: 14/11/2023
• Target sample size: 150
• Study type: Interventional
• Intervention(s): 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, initial and second Triggerfish measurements after eye drop treatment will be used to assess the effectiveness of the treatment intervention

Outcome(s)

• Primary Outcome: Obtain 24-hour IOP fluctuation pattern and various profile parameters (Acrophase, Amplitude, Bathyphase etc.)
• Secondary Outcome: Evaluation for visual acuity test, slit lamp microscopy, intraocular pressure and adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Higashide Tomomi
• Secondary Sponsor: SEED Co.,Ltd.