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OpenTrials
Completed

NCT Number: NCT04145830

UCP Glaucoma Treatment for Primary Glaucoma in China

To collect safety and efficacy data on Ultrasound Cycle Plasty treatment (UCP) in primary glaucoma asian patients.

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Key information

Conditions

Glaucoma Treatment Using Focused Ultrasound Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

E&ENT Fudan University, Shanghai, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ultrasound Cyclo Plasty (UCP)

Device

Cyclocoagulation using High Intensity Focused Ultrasound

Other names: UCP by EyeOP1 device

Primary outcomes

  1. Efficacy endpoint : reduction of the intraocular pressure

    Time frame: 6 months

    Reduction of the intraocular pressure relative to the preoperative value at each follow-up visits in mmHg and in % of reduction

Secondary outcomes

  1. Safety endpoint: rate of per operative complications

    Time frame: 6 months

    Rate of per-operative device and/or procedure related adverse events

  2. Safety endpoint: rate of post-operative complications

    Time frame: 6 months

    Rate of post-operative complications during the follow-up period

  3. Efficacy endpoint: Number of ocular hypotensive medications

    Time frame: 6 months

    Mean number of IOP lowering medications at each visit during the follow-up period

Sponsors and collaborators

Lead sponsor

EyeTechCare

Industry

Registry information

Official study title

Efficacy and Safety of UCP in the Treatment of Primary Glaucoma in China

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2019
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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