Glaucoma Treatment Using Focused Ultrasound Clinical Trial
Official title:
Efficacy and Safety of UCP in the Treatment of Primary Glaucoma in China
| Verified date | October 2019 |
| Source | EyeTechCare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To collect safety and efficacy data on Ultrasound Cycle Plasty treatment (UCP) in primary glaucoma asian patients.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | November 2, 2020 |
| Est. primary completion date | April 29, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Primary Open Angle and primary Angle Closure glaucoma - Subject where the IOP is not adequately controlled with glaucoma medication, and can not or not agree for incisional glaucoma surgery - IOP = 21 mmHg and = 40 mmHg - Best Corrected Visual Acuity > Hand Motion - Patient able and willing to sign the informed consent and complete postoperative followup requirements Exclusion Criteria: - History of ocular or retrobulbar tumor - Ocular infection within 14 days prior to the procedure of Ultrasound Cyclo Plasty (UCP) - History of Cyclo-destructive procedures (cryotherapy, Laser transscleral cyclophotocoagulation; Laser endophotocoagulation) - Congenital glaucoma - History of ciliary body surgery or vitrectomy in the study eye - Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema, retinal detachment) |
| Country | Name | City | State |
|---|---|---|---|
| China | E&ENT Fudan University | Shanghai | |
| China | Shanghai Eye Diseases Prevention and Treatment Center - Department of Ophthalmology | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| EyeTechCare |
China,
Aptel F, Denis P, Rouland JF, Renard JP, Bron A. Multicenter clinical trial of high-intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery. Acta Ophthalmol. 2016 Aug;94(5):e268-77. doi: 10.1111/aos.12913. Epub 2015 Nov 7. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy endpoint : reduction of the intraocular pressure | Reduction of the intraocular pressure relative to the preoperative value at each follow-up visits in mmHg and in % of reduction | 6 months | |
| Secondary | Safety endpoint: rate of per operative complications | Rate of per-operative device and/or procedure related adverse events | 6 months | |
| Secondary | Safety endpoint: rate of post-operative complications | Rate of post-operative complications during the follow-up period | 6 months | |
| Secondary | Efficacy endpoint: Number of ocular hypotensive medications | Mean number of IOP lowering medications at each visit during the follow-up period | 6 months |