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iStent inject with cataract surgery for primary angle closure glaucoma

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062230007
Enrollment
7
Registered
2023-04-24
Start date
2023-08-03
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

Primary angle closure glaucoma Primary angle closure glaucoma

Interventions

iStent inject with cataract surgery

Sponsors

Hirooka Kazuyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
intraocular pressure 6 months after surgery

Secondary

MeasureTime frame
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

Contacts

Public ContactKazuyuki Hirooka

Hiroshima University Hospital

onoehir@hiroshima-u.ac.jp+81-82-257-4257

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026