Study participants with secondary glaucoma after vitrectomy unresponsive to medication
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Number of intraocular pressure-lowering medications;Intraocular pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity;Adverse event; | — |
Countries
China
Contacts
The First Affiliated Hospital of Dalian Medical University