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Study on the Efficacy and Safety of Ultrasound Cycloplasty in the Treatment of Secondary Glaucoma After Vitrectomy

Study on the Efficacy and Safety of Ultrasound Cycloplasty in the Treatment of Secondary Glaucoma After Vitrectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115730
Enrollment
Unknown
Registered
2025-12-30
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Study participants with secondary glaucoma after vitrectomy unresponsive to medication

Interventions

Experimental group:Undergo ultrasound cycloplasty

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged >=18 years and 30 mmHg for more than 5 days despite treatment with two or more types of IOP-lowering medications (excluding 20% mannitol); 3.Patients whose ocular condition allows them to cooperate with preoperative examinations such as UBM (or anterior segment OCT) and IOL Master (or other optical biometry); 4.Patients who voluntarily participate in this clinical study, are able to sign the informed consent, and can complete the postoperative follow-up requirements.

Exclusion criteria

Exclusion criteria: 1.Eye of interest has an eye infection within two weeks prior to surgery; 2.Eye of interest has non-glaucomatous intraocular diseases affecting intraocular pressure (such as choroidal hemorrhage or detachment, retinal detachment, lens subluxation, thyroid eye disease, etc.); 3.Eye of interest has ocular surface tissue proliferation or scarring affecting the positioning of the EyeOP1 device; 4.Eye of interest has a history of intraocular or posterior ocular tumors; 5.Eye of interest has anterior segment anatomical abnormalities causing scleral thinning or dilation, or ectopic ciliary body. 6.Eye of interest has previously undergone treatments to reduce ciliary body secretory function (such as ciliary body cryotherapy, ciliary body laser photocoagulation, ultrasound ciliary coagulation more than 3 times, etc.). 7.White-to-white (WTW) distance of the eye of interest is greater than 13.4 mm; 8.Patients whose best-corrected visual acuity in the non-study eye is less than 0.05; 9.Any systemic disease that may affect patient follow-up (such as heart or lung failure greater than NYHA class II, long-term bedridden patients unable to sit up, etc.); 10.Pregnant or breastfeeding women. 11.Participation in another drug/device clinical trial within 30 days; 12.Patients whose eye of interest requires another vitrectomy; 13.Any patient deemed unsuitable for participation in this trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Number of intraocular pressure-lowering medications;Intraocular pressure;

Secondary

MeasureTime frame
Best corrected visual acuity;Adverse event;

Countries

China

Contacts

Public ContactMa Xiang

The First Affiliated Hospital of Dalian Medical University

xma9467@vip.sina.com+86 411 8363 5963

Outcome results

None listed

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