A device iStent inject W is a tiny tube that helps fluid drain out of the eye, lowering the pressure inside the eye

Prospective, Post-Approval Phase IV Study of the iStent inject W Trabecular Micro-Bypass System in Subjects with Primary Open Angle Glaucoma, Pseudo-exfoliative Glaucoma or Pigmentary Glaucoma - NA

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110234

Enrollment

Registered

2026-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: H408- Other glaucoma Health Condition 2: H401- Open-angle glaucoma Health Condition 3: H408- Other glaucoma

Interventions

Intervention1: iStent inject W Trabecular Micro-Bypass System in adult subjects: After the 01 day of implant follow-up will be performed on Day 7, Day 14 (in case of surgery in both eyes), Day 30, and

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subject must be 18 years of age 2.Diagnosis of primary open-angle glaucoma, pseudo-exfoliative glaucoma, or pigmentary glaucoma (either single or both eyes) 3.Glaucoma should be mild to moderate (defined as C/D ratio 0.8) 4.Pre-operative IOP of up to 30 mmHg (with/without medications) 5.Able and willing to attend scheduled follow-up examinations for 180 days postoperatively 6.Able and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Eyes with primary angle-closure glaucoma or secondary angle-closure glaucoma, including neovascular glaucoma 2. Aphakic subjects 3. Pseudophakic subjects with anterior chamber (AC) IOLs 4. Subjects with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome, or any other type of condition that may cause elevated episcleral venous pressure 5. Prior stent implantation in the study eye 6. Prior glaucoma treatment with laser or surgery 7. Any pathology/underlying condition, which in the Investigatorâ??s opinion may pose a risk to the subjectâ??s participation in the study 8. Current participation in any study, or participation within 30 calendar days of screening examination 9. Pregnant or nursing women

Design outcomes

Primary

Measure	Time frame
Postoperative adverse events monitoringTimepoint: Day 7, Day 14 (in case of surgery in both eyes), Day 30, and Day 180	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactSaikat Dutta

Glaukos Corporation

sdutta@glaukos.com9619191796

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026