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NCT Number: NCT06246136

Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery

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.

Recruiting

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ELIOS Clinical Site, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

ELIOS

Procedure

Following cataract surgery, surgeon will proceed to ELIOS treatment.

Competitor Device

Procedure

Following cataract surgery, surgeon will proceed to Competitor treatment.

Primary outcomes

  1. PRIMARY EFFECTIVENESS ENDPOINTS : IOP

    Time frame: 12 months

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

Secondary outcomes

  1. SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP

    Time frame: 24 months

    Proportion of patients achieving 20% reduction in post-washout diurnal IOP from baseline.

  2. SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications

    Time frame: 12 months

    change in number of hypotensive medications from screening to 12 months

  3. SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP

    Time frame: 12 months

    Mean change in treated IOP from screening to 12 months

  4. SECONDARY EFFECTIVENESS ENDPOINTS : Medications

    Time frame: 12 months

    Proportion of patients Medication free at 12 months

Other outcomes

  1. SAFETY ENDPOINTS : adverse events

    Time frame: 24 months

    Rates of ocular adverse events

  2. Safety endpoints: Retinal nerve fiber layer thickness

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

    measurement of Retinal nerve fiber layer thickness

Study contacts

Contact information is provided by the study sponsor or research team.

Cameron Hudson

CONTACT

[email protected]

+33388308811

Sponsors and collaborators

Lead sponsor

Elios Vision, Inc.

Industry

Registry information

Official study title

A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Effectiveness of ELIOS vs Competitor in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Feb 7, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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