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Comparing ELIOS with other devices for glaucoma patients undergoing cataract surgery

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

Not applicable Interventional Elios Vision, Inc. · NCT06246136

This study is testing whether the ELIOS device can safely lower eye pressure better than another device for people with mild to moderate glaucoma who are having cataract surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment194 (estimated)
Ages40 Years and up
SexAll
SponsorElios Vision, Inc. Industry-sponsored
Locations16 sites (Leuven and 15 other locations)
Trial IDNCT06246136 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of the ELIOS device in conjunction with cataract surgery for patients with open-angle glaucoma. It will compare the reduction of intraocular pressure (IOP) at 12 months post-surgery between patients using ELIOS and those using a competitor device. Participants must be 40 years or older and diagnosed with mild to moderate forms of glaucoma. The study will involve phacoemulsification with intraocular lens implantation as part of the surgical procedure.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 and older with mild to moderate primary open-angle glaucoma and visually significant cataracts.

Not a fit: Patients with angle closure glaucoma or secondary forms of glaucoma will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for managing intraocular pressure in glaucoma patients undergoing cataract surgery.

How similar studies have performed: Other studies have shown promising results with similar approaches in managing glaucoma during cataract surgery, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female subjects.
2. 40 years old or older.
3. Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma:
4. Visually significant cataract eligible for phacoemulsification.

Exclusion Criteria:

1. All forms of angle closure glaucoma
2. 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
3. Congenital or developmental glaucoma
4. 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

Where this trial is running

Leuven and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Open Angle GlaucomaExcimer LaserMicro-bypassTrabeculostomy
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.