iStent inject with cataract surgery for primary angle closure glaucoma

JRCT ID: jRCTs062230007

Registered date:24/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary angle closure glaucoma
• Date of first enrollment: 03/08/2023
• Target sample size: 7
• Study type: Interventional
• Intervention(s): iStent inject with cataract surgery

Outcome(s)

• Primary Outcome: intraocular pressure 6 months after surgery

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Hirooka Kazuyuki
• Source(s) of Monetary Support: Glaucos Japan