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Efficacy and safety of iStent inject with cataract surgery for primary angle closure glaucoma

iStent inject with cataract surgery for primary angle closure glaucoma

6

No. Age (y) Gender Side (R/L) Baseline IOP (mmHg) No. glaucoma medication 1 83 Female L 15 3 2 64 Female L 15 2 3 62 Female R 16 0 4 65 Female R 16 4 5 74 Female R 12 2 6 64 Male L 18 0

The target number of cases is 7, with 6 cases enrolled, and the observation period for all 6 cases has ended.

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Intraocular Pressure (number of glaucoma medications) No. Baseline 1d 1w 1m 3m 6m 1 15 (3) 15 (0) 15 (0) 13 (0) 14 (0) 14 (0) 2 15 (2) 11 (0) 12 (0) 12 (0) 14 (0) 15 (0) 3 16 (0) 12 (0) 12 (0) 12 (0) 10 (0) 9 (0) 4 16 (4) 15 (0) 14 (0) 15 (0) 16 (0) 16 (2) 5 12 (2) 15 (0) 13 (0) 14 (0) 14 (0) 17 (0) 6 18 (0) 24 (0) 18 (2) 18 (0) 14 (2) 14 (2)

In patients with PACG, phacoemulsification with trabecular microbypass Stent W implantation was demonstrated to be a safe and effective procedure.

April. 01, 2025

Nov. 30, 2024

https://pmc.ncbi.nlm.nih.gov/articles/PMC11685551/

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs062230007

Hirooka Kazuyuki

Hiroshima University Hospital

Kasumi 1-2-3 Minami-ku, Hiroshima

kazuyk@hiroshima-u.ac.jp

Hirooka Kazuyuki

Hiroshima University Hospital

Kasumi 1-2-3 Minami-ku, Hiroshima

+81-82-257-4257

onoehir@hiroshima-u.ac.jp

Complete

April. 24, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1 Patients with primary angle closure glaucoma who are 18 years of age or older at the time of consent
2 Patients who can give informed consent to participate in this study
3 Patients who are able to come to the hospital for 6 months after the surgery.

1 Patients complicated by phacodonesis or zonular weakness
2 Patients with anterior synechiae exceeding 25% or with anterior synechiae on the nasal side
3 Patients who have difficulty in obtaining cooperation for postoperative gonioscopy
4 Patients with an MD value of less than -12 dB on a static visual field test (Humphrey 24-2)
5 Patients with a preoperative intraocular pressure of 25 mmHg or more
6 Corneal endothelial cell density less than 1,500 cells/mm2
7 Patients with metal allergy
8 Patients with a history of glaucoma surgery in the subject eye
9 Pregnant and lactating women, women who may be pregnant, or women who wish to have a baby.
10 The investigator and the research subject have a relationship as faculty member and student
11 Any other person who is deemed inappropriate by the investigators

Both

Primary angle closure glaucoma

iStent inject with cataract surgery

Primary angle closure glaucoma

iStent

D015812

intraocular pressure 6 months after surgery

1 success rate: success is defined as IOP of 15 mmHg or less with IOP reduction of 20% or more (criterion 1) and IOP of 18 mmHg or less with IOP reduction of 20% or more (criterion 2).
2 The number and rate of adverse events

+81-82-257-1551

Mar. 08, 2023

none