Zhongshan Ophthalmic Center, Sun Yat-sen University
1. Efficacy: 1. Main objective: (1)Assess the decrease in postoperative intraocular pressure from baseline and evaluate the final results (the percentage of patients whose conditions have significant improved and the variation of the percentage of median intraocular pressure. (2)Assess the amount of medication after surgery.
2. Secondary goals:(1) Compare median intraocular pressure with baseline at each postoperative follow-up and access the variation of median intraocular pressure from baseline at each postoperative follow-up. (2) Count the number of intraocular pressure lowering drugs at each postoperative follow-up.
b.Safety: Investigate the incidence of all device-related(or procedure-related) adverse events during the study (intraoperative and postoperative follow-up).
Age
18–90
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
The target eye was diagnosed as primary open-angle glaucoma; diagnostic criteria: IOP(intraocular pressure)≥ 21, open angle, typical glaucoma visual field and optic disc damage;
Patients treated with glaucoma medications cannot control intraocular pressure effectively;
Patients with 21mmHg ≤ IOP ≤ 30mmHg;
VA(visual acuity)≥HM(hand motions);
Patients that have failed conventional glaucoma surgery (trabeculectomy) or are not suitable for surgery;
Patients who have not received intraocular surgery or laser treatment 90 days before receiving HIFU;
Aged from 18 to 90 years old;
Sign informed consent and be willing to provide visit data;
You may not be if
Either eye have any infections two weeks before the surgery;
The target eye has history of ciliary surgery, intraocular or retrobulbar tumor;
The target eye is neovascular glaucoma;
The target eye is aphakic eye;
Anterior anatomical abnormalities cause scleral expansion or ciliary body ectopic;
Non-glaucoma intraocular diseases that affect intraocular pressure;
Within 30 days, the patient participated in or was simultaneously included in other clinical trials;
Patients during pregnancy or lactation;
Any systemic disease that may affect patient follow-up.
Clareo Health | UCP (Ultrasound Cyclo Plasty) in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
