Safety and Feasibility of the ELIOS System in POAG Patients | NCT05999006

Studies
Safety and Feasibility of the ELIOS System in POAG Patients

NCT05999006

Sponsor

Elios Vision, Inc.

Status

Completed

Last Update Posted

Jun 16, 2026Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Glaucoma, Primary Open Angle

Interventions

ELIOS Procedure

Countries

United States

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

Jun 2026

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

Oct 18, 2023Actual

Primary Completion Date

Apr 28, 2026Actual

Completion Date

Apr 28, 2026Actual

First Submitted Date

Aug 11, 2023

First Submission Date that Met QC Criteria

Aug 16, 2023

First Posted Date

Aug 21, 2023Actual

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

Jun 13, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG)

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ELIOS Procedure	Experimental	ELIOS Procedure	Device: ELIOS Procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ELIOS Procedure	Device	Treatment with the ELIOS System	ELIOS Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications	Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications	12 Months
Mean Change in DIOP from baseline on the same or fewer medications	Mean Change in DIOP from baseline on the same or fewer medications	12 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of mild to moderate POAG
Medicated IOP of <=24 mmHg
Shaffer angle grade of III or IV
CD ratio <=0.8
At least 45 years old

Exclusion Criteria:

Closed-angle and secondary glaucomas
Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery
Cannot undergo medication washout in the study eye
Diagnosis of degenerative visual disorders Non-study eye with BCVA worse than 20/80 Known corticosteroid responder Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iqbal (Ike) Ahmed, MD	Prism Eye Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elios Vision Clinical Site		Glendale	Arizona	85306	United States
Elios Vision Clinical Site

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

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided