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UCP Glaucoma Treatment for Primary Glaucoma in China

Sponsor
EyeTechCare (Industry)
Overall Status
Completed
CT.gov ID
NCT04145830
Collaborator
(none)
30
Enrollment
2
Locations
1
Arm
14.1
Actual Duration (Months)
15
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasound Cyclo Plasty (UCP)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of UCP in the Treatment of Primary Glaucoma in China
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Apr 29, 2020
Actual Study Completion Date :
Nov 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ultrasound Cyclo Plasty (UCP)

Ultrasound Cyclo Plasty (UCP) using focused ultrasound

Device: Ultrasound Cyclo Plasty (UCP)
Cyclocoagulation using High Intensity Focused Ultrasound
Other Names:
  • UCP by EyeOP1 device

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy endpoint : reduction of the intraocular pressure [6 months]

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

    Secondary Outcome Measures

    1. Safety endpoint: rate of per operative complications [6 months]

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

    2. Safety endpoint: rate of post-operative complications [6 months]

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

    3. Efficacy endpoint: Number of ocular hypotensive medications [6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Eye Diseases Prevention and Treatment Center - Department of Ophthalmology Shanghai China 2000040
    2 E&ENT Fudan University Shanghai China

    Sponsors and Collaborators

    • EyeTechCare

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    EyeTechCare
    ClinicalTrials.gov Identifier:
    NCT04145830
    Other Study ID Numbers:
    • CS18-CHN-04
    First Posted:
    Oct 31, 2019
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by EyeTechCare
    Glaucoma, ciliary body, ultrasound
    Additional relevant MeSH terms:
    Glaucoma

    Study Results

    No Results Posted as of Aug 19, 2021