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Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

EyeOP1 device

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Ultrasound, Ciliary body

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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…)

Sites / Locations

UZ Leuven - University Hospital
The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
Cisanello Hospital
Santa Maria Hospital - Faculty of Medicine of Lisbon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focused Ultrasound treatment

Arm Description

Ultrasound ciliary pasty (UCP) using focused ultrasound

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Efficacy endpoint : Mean IOP (mmHg)

Evolution of the Mean IOP (mmHg) at each visit during the follow-up period (Baseline to 24 months)

Efficacy Endpoint : Mean IOP variation (%)

Mean IOP variation (%) at each visit during the follow-up period

Mean Number of ocular hypotensive medications

Mean number of ocular hypotensive medication at each visit during the followup period

Full Information

NCT ID

NCT02789293

First Posted

May 24, 2016

Last Updated

August 18, 2021

Sponsor

EyeTechCare

1. Study Identification

Unique Protocol Identification Number

NCT02789293

Brief Title

Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

Official Title

Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

May 2016 (Actual)

Primary Completion Date

October 12, 2017 (Actual)

Study Completion Date

October 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EyeTechCare

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Glaucoma, Ultrasound, Ciliary body

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Focused Ultrasound treatment

Arm Type

Experimental

Arm Description

Ultrasound ciliary pasty (UCP) using focused ultrasound

Intervention Type

Device

Intervention Name(s)

EyeOP1 device

Intervention Description

Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound

Primary Outcome Measure Information:

Title

Efficacy endpoint : Reduction of intraocular pressure

Description

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Safety : rate of per and post-operative complications/adverse effects

Description

rate of per-operative device and /or procedure related adverse events and post-operative complications at each follow-up visits

Time Frame

24 months

Title

Efficacy endpoint : Mean IOP (mmHg)

Description

Evolution of the Mean IOP (mmHg) at each visit during the follow-up period (Baseline to 24 months)

Time Frame

24 months

Title

Efficacy Endpoint : Mean IOP variation (%)

Description

Mean IOP variation (%) at each visit during the follow-up period

Time Frame

24 months

Title

Mean Number of ocular hypotensive medications

Description

Mean number of ocular hypotensive medication at each visit during the followup period

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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…)

Facility Information:

Facility Name

UZ Leuven - University Hospital

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Cisanello Hospital

City

Pisa

Country

Italy

Facility Name

Santa Maria Hospital - Faculty of Medicine of Lisbon

City

Lisboa

ZIP/Postal Code

1649-028

Country

Portugal

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

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