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Prospective, multicenter, randomized, open, parallel controlled clinical trial of disposable aqueous humor collector for accurate aqueous humor collection.

Prospective, multicenter, randomized, open, parallel controlled clinical trial of disposable aqueous humor collector for accurate aqueous humor collection.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039215
Enrollment
Unknown
Registered
2020-10-22
Start date
2020-10-30
Completion date
Unknown
Last updated
2021-01-25

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

Conditions

Patients who need paracentesis to lower intraocular pressure or to collect aqueous humor for laboratory tests, etc

Interventions

control group:Shurui BD disposable sterile insulin syringe
experimental group:disposable anterior chamber puncture device produced by Hangzhou Huashi Novi

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The subjects voluntarily participated in the trial and signed the informed consent; 2. Patients aged 18-80 years old, regardless of gender; 3. Patients who need to perform anterior chamber puncture, drainage and fluid collection, such as anterior chamber drainage to reduce intraocular pressure, collecting anterior chamber water for clinical examination, etc.; 4. Subjects with 21mm <= ocular axis <= 26.5mm; 5. The subjects who can communicate well with researchers and comply with the experimental requirements.

Exclusion criteria

Exclusion criteria: 1. Patients with ocular surface or ocular adnexal infection, including keratitis, conjunctivitis, anterior scleritis, lacrimal duct infection, lacrimal gland inflammation, Meibomianitis, blepharitis or anterior orbital cellulitis caused by bacteria, fungi, viruses, protozoa, etc; 2. Patients with low intraocular pressure (< 7 mmHg); 3. Patients with corneal ulcer and perforation; 4. Patients with unhealed eyeball rupture; 5. Patients with severe corneal opacity and corneal edema that affect the observation of puncture needle in the process of puncture; 6. Patients with hyphema, gel like inflammatory exudation of anterior chamber, etc.; 7. Objects with shallow anterior chamber (peripheral anterior chamber depth < 1 / 4 corneal thickness or central anterior chamber depth < 2.2mm); 8. Local or peripheral iris bulging caused by posterior synechia, local bulging should avoid bulging area during puncture; 9. Lens dislocation, aphakia and other causes of vitreous hernia such as anterior chamber; 10. Silicone oil or gas filled eyes after vitrectomy; 11. Patients suspected or diagnosed as malignant glaucoma; 12. Patients with history of intraocular expulsion hemorrhage; 13. Subjects of neovascular glaucoma and iris neovascularization; 14. The coagulation function was abnormal, and the researchers believed that the patient had the risk of anterior chamber hemorrhage after anterior chamber puncture.

Design outcomes

Primary

MeasureTime frame
The success rate of accurate collection of anterior chamber (40ul = aqueous volume = 60ul) was used as the effective evaluation indicator.;

Secondary

MeasureTime frame
Instrument operability score;

Countries

China

Contacts

Public ContactYueguang Sun

Hangzhou Sightnovo Medical Technology Co., Ltd

yueguang.sun@sightnovo.com+86 13601106130

Outcome results

None listed

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