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Safety and efficacy study of iStent inject W glaucoma drainage device in clinical application of patients with primary open-angle glaucoma and cataract patients

Safety and efficacy study of iStent inject W glaucoma drainage device in clinical application of patients with primary open-angle glaucoma and cataract patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097212
Enrollment
Unknown
Registered
2025-02-14
Start date
2024-12-19
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Glaucoma

Interventions

Study Group:The patient undergoes cataract surgery and implantation of an intraocular lens (astigmatism or non-astigmatism) followed by implantation of the iStent inject W device.

Sponsors

The Second Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=40 years, gender is not limited. 2. Clinically confirmed diagnosis of mild to moderate primary open-angle glaucoma (visual field MD dB <= -12) who is receiving topical intraocular hypotensive medication. 3. Good eye health, no other lesions affecting vision (except for residual refractive error, cataract and glaucoma), and both eyes must meet the ocular standards. 4. Planned to undergo routine cataract surgery. 5. Able to understand and willing to sign an informed consent document, willing and able to participate in standard preoperative and postoperative study visits.

Exclusion criteria

Exclusion criteria: 1. Primary angle-closure glaucoma, secondary angle-closure glaucoma (including neovascular glaucoma). 2. Have retrobulbar tumors, thyroid eye disease, Sturge - Weber syndrome, or other conditions that may cause elevated extrascleral venous pressure. 3. Amblyopia. 4. Previous anterior or posterior chamber surgery (such as vitrectomy, laser iridotomy, glaucoma filtration surgery and elective laser trabeculoplasty within 90 days prior to screening, etc.). 5. History of diabetic retinopathy, macular degeneration, retinal detachment. 6. Acute or chronic diseases known to affect postoperative vision (such as immunocompromise, connective tissue diseases, clinically evident atopic diseases, diabetes mellitus and any other such diseases). 7. Pregnant or lactating women (pregnancy and lactation may affect the results of the study, and there is a lack of adequate studies of pregnant women, and they are not included unless the potential benefits outweigh the risks to the fetus).

Design outcomes

Primary

MeasureTime frame
Post operation IOP;

Secondary

MeasureTime frame
Visual Field;Numbers of antiglaucoma eye drops;Surgical complications;

Countries

China

Contacts

Public ContactPeng Lu

The Second Hospital of Lanzhou University

penglu@lzu.edu.cn+86 187 9479 7009

Outcome results

None listed

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