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Safety and Effectiveness of ELIOS vs Competitor Device in Open-Angle Glaucoma Patients Undergoing Cataract Surgery
Led by Elios Vision, Inc. · Updated on 2025-11-26
194
Participants Needed
16
Research Sites
117 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are assessing the safety and effectiveness of the ELIOS device compared to a competitor device in patients with open-angle glaucoma who are undergoing cataract surgery. The main goal is to evaluate how well these devices reduce intraocular pressure (IOP) 12 months after surgery in adults aged 40 and older with mild to moderate glaucoma. This trial is a prospective, multicenter, randomized clinical study sponsored by Elios Vision, Inc. Participants will undergo cataract surgery using phacoemulsification with intraocular lens implantation. After the cataract surgery, patients will receive treatment with either the ELIOS device or a competitor device, assigned randomly. The study includes two active treatment groups and involves single masking to maintain objectivity. During the study, participants will be monitored at regular intervals for IOP levels at 12 and 24 months, the number of hypotensive medications used, and treated IOP at 12 months. Researchers will track safety and effectiveness through these measures to compare the outcomes between the two devices. The trial is expected to continue until March 2028, with careful follow-up to assess the longer-term effects of treatment.
CONDITIONS
Brief Title
Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 except selective laser trabeculoplasty occurring less than 6 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and immediate recovery period
Participants undergo cataract surgery followed immediately by treatment with either the ELIOS device or a competitor device.
1 surgery visit (in-person)
Duration - Up to 24 months
Participants attend follow-up visits to monitor safety and effectiveness of the treatment after surgery.
Multiple visits over 24 months
Trial Site Locations
Total: 16 locations
1
ELIOS Clinical Site
Leuven, Belgium
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2
Elios Clinical Site
Avranches, France
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3
ELIOS Clinical Site
Bordeaux, France
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4
ELIOS clinical site
Paris, France
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5
ELIOS Clinical Site
Bochum, Germany
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6
Elios clinical site
Bonn, Germany
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7
ELIOS clinical site
Heidelberg, Germany
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8
ELIOS Clinical Site
Maastricht, Netherlands
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9
ELIOS clinical site
Barcelona, Spain
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10
ELIOS Clincal Site
Madrid, Spain
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11
ELIOS Clinical site
Madrid, Spain
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12
ELIOS Clinical Site
East Grinstead, United Kingdom
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13
ELIOS Clinical Site
Edinburgh, United Kingdom
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14
ELIOS Clinical Site
Guildford, United Kingdom
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15
ELIOS clinical site
London, United Kingdom
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16
ELIOS Clinical Site
Manchester, United Kingdom
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Research Team
C
Cameron Hudson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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