NCT02789293

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2019

Completed
Last Updated

August 19, 2021

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

May 24, 2016

Last Update Submit

August 18, 2021

Conditions

Glaucoma

Keywords

GlaucomaUltrasoundCiliary body

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

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

    24 months

  • Efficacy endpoint : Mean IOP (mmHg)

    24 months

  • Efficacy Endpoint : Mean IOP variation (%)

    24 months

  • Mean Number of ocular hypotensive medications

    24 months

Study Arms (1)

Focused Ultrasound treatment

EXPERIMENTAL

Ultrasound ciliary pasty (UCP) using focused ultrasound

Device: EyeOP1 device

Interventions

EyeOP1 deviceDEVICE

Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound

Focused Ultrasound treatment

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UZ Leuven - University Hospital

Leuven, 3000, Belgium

Location

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

Tel Litwinsky, 52621, Israel

Location

Cisanello Hospital

Pisa, Italy

Location

Santa Maria Hospital - Faculty of Medicine of Lisbon

Lisbon, 1649-028, Portugal

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 2, 2016

Study Start

May 1, 2016

Primary Completion

October 12, 2017

Study Completion

October 4, 2019

Last Updated

August 19, 2021

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)IT(1)IL(1)PT(1)