Glaucoma Treatment Using Focused Ultrasound in Open Angle... | NCT02789293

Studies
Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

NCT02789293

Sponsor

EyeTechCare

Status

Completed

Last Update Posted

Aug 19, 2021Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Glaucoma

Interventions

EyeOP1 device

Countries

Belgium
Israel
Italy
Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Oct 12, 2017Actual

Completion Date

Oct 4, 2019Actual

First Submitted Date

May 24, 2016

First Submission Date that Met QC Criteria

Jun 1, 2016

First Posted Date

Jun 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2021

Last Update Posted Date

Aug 19, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Focused Ultrasound treatment	Experimental	Ultrasound ciliary pasty (UCP) using focused ultrasound	Device: EyeOP1 device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EyeOP1 device	Device	Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound	Focused Ultrasound treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy endpoint : Reduction of intraocular pressure	Reduction of intraocular pressure at 24 months relative to the preoperative value assessed at each follow-up visits with the final measurement of success at 24 months	24 months

Secondary Outcomes

Measure	Description	Time Frame
Safety : rate of per and post-operative complications/adverse effects	rate of per-operative device and /or procedure related adverse events and post-operative complications at each follow-up visits	24 months
Efficacy endpoint : Mean IOP (mmHg)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Open Angle Glaucoma patient (Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG) and PseudoExfoliative Glaucoma (PXF))
Any patients without previous conventional glaucoma surgery failure (trabeculectomy, Deep Sclerectomy, Ahmed valve, drainage device implantation, cyclo cryotherapy, Diode laser cyclo-destruction)
Subjects where the IOP is not adequately controlled with glaucoma medication, with IOP ≥ 21 mm Hg and <30 mmHg
No previous intraocular surgery or laser treatment during the 90 days before HIFU Day
Age > 18 years and < 90 years
Patient able and willing to complete postoperative follow-up requirements

Exclusion Criteria:

Patient who has been diagnosed for normal tension glaucoma
Ocular or retrobulbar tumor
Ocular infection within 14 days prior to the HIFU procedure
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, clinically significant macular edema…)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven - University Hospital		Leuven		3000	Belgium
The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases