NCT06246136

Brief Summary

The primary study objective is to compare the effectiveness of the combination of phacoemulsification with intraocular lens implant with ELIOS or competitor device in reducing IOP at 12 months postoperatively.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
6 countries

16 active sites

Status
recruiting

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 Progress56%
Dec 2023Mar 2028

Study Start

First participant enrolled

December 5, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Expected
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

January 30, 2024

Last Update Submit

November 24, 2025

Conditions

Open Angle Glaucoma

Keywords

Excimer LaserMicro-bypassTrabeculostomy

Outcome Measures

Primary Outcomes (1)

  • PRIMARY EFFECTIVENESS ENDPOINTS : IOP

    Mean change in post-washout diurnal IOP from baseline to 12 months.

    12 months

Secondary Outcomes (4)

  • SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP

    24 months

  • SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications

    12 months

  • SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP

    12 months

  • SECONDARY EFFECTIVENESS ENDPOINTS : Medications

    12 months

Other Outcomes (2)

  • SAFETY ENDPOINTS : adverse events

    24 months

  • Safety endpoints: Retinal nerve fiber layer thickness

    12 months (with a planned extension of analysis at 24 months)

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

ELIOS

Procedure: ELIOS

Arm 2

ACTIVE COMPARATOR

Competitor Device

Procedure: Competitor Device

Interventions

ELIOSPROCEDURE

Following cataract surgery, surgeon will proceed to ELIOS treatment.

Arm 1
Competitor DevicePROCEDURE

Following cataract surgery, surgeon will proceed to Competitor treatment.

Arm 2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects.
  • years old or older.
  • Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma:
  • Visually significant cataract eligible for phacoemulsification.

You may not qualify if:

  • All forms of angle closure glaucoma
  • Secondary glaucoma, including traumatic, neovascular, uveitic, lens-induced, steroid-induced, angle-recession, glaucoma associated with vascular disorders, and glaucoma associated with increased episcleral venous pressure
  • Congenital or developmental glaucoma
  • Prior incisional glaucoma surgery, intraocular surgery or ocular laser treatment of any type with the exception of selective laser trabeculoplasty (SLT) occurring a minimum of 6 months prior to the Screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

ELIOS Clinical Site

Leuven, Belgium

RECRUITING

Elios Clinical Site

Avranches, France

RECRUITING

ELIOS Clinical Site

Bordeaux, France

RECRUITING

ELIOS clinical site

Paris, France

RECRUITING

ELIOS Clinical Site

Bochum, Germany

RECRUITING

Elios clinical site

Bonn, Germany

RECRUITING

ELIOS clinical site

Heidelberg, Germany

RECRUITING

ELIOS Clinical Site

Maastricht, Netherlands

RECRUITING

ELIOS clinical site

Barcelona, Spain

RECRUITING

ELIOS Clincal Site

Madrid, Spain

RECRUITING

ELIOS Clinical site

Madrid, Spain

RECRUITING

ELIOS Clinical Site

East Grinstead, United Kingdom

RECRUITING

ELIOS Clinical Site

Edinburgh, United Kingdom

RECRUITING

ELIOS Clinical Site

Guildford, United Kingdom

RECRUITING

ELIOS clinical site

London, United Kingdom

RECRUITING

ELIOS Clinical Site

Manchester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Central Study Contacts

Cameron Hudson

CONTACT

+33388308811Cameron.Hudson@bausch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

December 5, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

March 31, 2028

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations

DE(3)FR(3)BE(1)NL(1)ES(3)GB(5)