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

Sponsor: Elios Vision, Inc.

NCT ID: NCT06246136

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
ELIOS (procedure), Competitor Device (procedure)
How long the study runs
Study runs about 60 months (dates as stated)
About the drug or intervention
ELIOS — procedure: Following cataract surgery, surgeon will proceed to ELIOS treatment. · Competitor Device — procedure: Following cataract surgery, surgeon will proceed to Competitor treatment.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at how well and how safely the ELIOS treatment works for people with open-angle glaucoma who are also having cataract surgery. Glaucoma is a condition where pressure in the eye can damage the optic nerve. It is run by Elios Vision, Inc.

Who can take part

  • Men or women aged 40 or over
  • Diagnosed with mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma
  • Have a cataract that affects vision and can be treated with standard cataract surgery (phacoemulsification)

Who may not be able to

  • Any type of angle closure glaucoma
  • Other glaucoma caused by injury, abnormal blood vessels, inflammation, the lens, steroid medicines, or blood vessel problems
  • Glaucoma present from birth or childhood
  • Previous glaucoma surgery, other eye surgery, or any eye laser treatment — except selective laser trabeculoplasty (SLT) done at least 6 months before the screening visit

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about how many visits there are and how long the study lasts.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
40 Years and over
Who
All
Number of participants
194
Started
2023-12-05
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for open angle glaucoma
  • • NA - 194 participants
  • • 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

Who can take part?

  • • Ages 40 Years and over
  • • Diagnosed with open angle glaucoma

Where?

  • • East Grinstead - ELIOS Clinical Site
  • • Edinburgh - ELIOS Clinical Site
  • • Guildford - ELIOS Clinical Site
  • • London - ELIOS clinical site
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Open Angle Glaucoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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.

Who cannot take part

  • ✗All forms of angle closure glaucoma
  • ✗Congenital or developmental glaucoma
See the full 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 Is This Study? (5 UK sites)

ELIOS Clinical Site

East Grinstead, United Kingdom

Recruiting
Site contact (verified)

ELIOS Clinical Site

Edinburgh, United Kingdom

Recruiting
Site contact (verified)

ELIOS Clinical Site

Guildford, United Kingdom

Recruiting
Site contact (verified)

ELIOS clinical site

London, United Kingdom

Recruiting
Site contact (verified)

ELIOS Clinical Site

Manchester, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Cameron Hudson

Sponsor contact

CONTACT

+33388308811 Cameron.Hudson@bausch.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06