Open-angled glaucoma glaucoma
Conditions
Interventions
Placebo or study drug is treated. Take two types of capsules daily: soft capsules (Diosgenin-rich Yam extract or its placebo) and hard capsules (Naringin or its placebo). The administration period is
Sponsors
Tohda Chihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet the following criteria will be included in this study. (1) Patients with open-angle glaucoma who have been receiving continuous treatment at an ophthalmology clinic for more than one year and have undergone five or more static visual field tests (equivalent to 24-2 sita standard) prior to the start of the trial. (2) MD value is less than -12 dB. (3) MD slope is less than -1.0 dB/year (gentle slope) (4) Intraocular pressure is stable with topical treatment (5) In normal-tension glaucoma, intraocular pressure is 16 mmHg or less during topical treatment (6) Written informed consent is obtained, and the patient can comply with the requirements during study participation
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be included in this study. (1) MD value worse than -12 dB (2) MD slope worse than -1.0 dB/year (steep slope) (3)Normal-tension glaucoma with intraocular pressure exceeding 16 mmHg during treatment (4) Any of the four points within 5 degrees of the fixation point has 0 dB (due to rapid progression of visual field loss) (5) Exfoliation glaucoma (due to unstable intraocular pressure and rapid progression of visual field loss) (6) Secondary glaucoma (due to unstable intraocular pressure and rapid progression of visual field loss) (7) Glaucoma in pathological myopia (due to unstable pressure and rapid progression of visual field loss) (8) History of optic disc bleeding (9) Participated in any other clinical trial within 30 days prior to screening (10) Allergy to Chinese yam or Japanese yam (11) Other reasons deemed inappropriate for participation in this study by the principal investigator (or co-investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Ophthalmic examinations and physical examinations will be conducted at baseline (0 months) and at 3, 6, 12, 18, and 24 months after study initiation. Based on the results of six static visual field tests (equivalent to the 24-2 sita standard) performed on the study eye, MD slope LMM of visual field sensitivity (dB) at each measurement point is conducted, and the progression trends are compared between groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Static visual field testing of the test eye (equivalent to 24-2 sita standard): Visual field sensitivity (dB) at each measurement point, proportion of advancing points, MD slope changes (Simple linear regression), and cluster analysis of the central visual field 2) Changes in intraocular pressure (Goldman) 3)Changes in retinal inner layer thickness measured by OCT 4) Effect of the presence or absence of papilledema during the study period on ophthalmological examination results 5) Cognitive function tests Spatial cognition TMT-A, B Clock drawing Cognitive impairment screening/memory MMSE-J Wechsler Memory Scale-Revised (WMS-R) | — |
Contacts
Public ContactChihiro Tohda
University of Toyama
Outcome results
None listed