Clinical trial NCT04899063: Excimer Laser Trabeculostomy Glaucoma Treatment Study
Official title: A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glaucoma, Primary Open Angle
Lead sponsor: Elios Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-24
Enrollment: 318
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG) undergoing cataract surgery


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild to moderate POAG
* Operable cataract, eligible for phacoemulsification with a BCVA of 20/40 or worse
* Medicated IOP of \<=24 mmHg
* Unmedicated diurnal IOP of \>=22 mmHg and \<=34 mmHg
* Shaffer angle grade of III or IV
* CD ratio \<=0.8
* At least 45 years old

Exclusion Criteria:

* Closed-angle and secondary glaucomas
* Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery
* Cannot undergo medication washout in the study eye
* Diagnosis of degenerative visual disorders
* Non-study eye with BCVA worse than 20/80
* Known corticosteroid responder
* Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control

Primary outcomes:
measure: Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%
timeFrame: 24 Month
Secondary outcomes:
measure: Mean Change in medication-free DIOP from baseline
timeFrame: 24 Month
Other outcomes:
Locations:
city: Glendale
country: United States
facility: ELIOS Vision Clinical Site
state: Arizona
city: Petaluma
country: United States
facility: ELIOS Vision Clinical Site
state: California
city: Fort Collins
country: United States
facility: ELIOS Vision Clinical Site
state: Colorado
city: Grand Junction
country: United States
facility: ELIOS Vision Clinical Site
state: Colorado
city: DeLand
country: United States
facility: ELIOS Vision Clinical Site
state: Florida
city: Largo
country: United States
facility: ELIOS Vision Clinical Site
state: Florida
city: Melbourne
country: United States
facility: ELIOS Vision Clinical Site
state: Florida
city: Vero Beach
country: United States
facility: ELIOS Vision Clinical Site
state: Florida
city: Rock Island
country: United States
facility: ELIOS Vision Clinical Site
state: Illinois
city: Overland Park
country: United States
facility: ELIOS Vision Clinical Site
state: Kansas
city: Chaska
country: United States
facility: ELIOS Vision Clinical Site
state: Minnesota
city: Saint Louis
country: United States
facility: ELIOS Vision Clinical Site
state: Missouri
city: Las Vegas
country: United States
facility: ELIOS Vision Clinical Site
state: Nevada
city: South Orange
country: United States
facility: ELIOS Vision Clinical Site
state: New Jersey
city: Oklahoma City
country: United States
facility: ELIOS Vision Clinical Site
state: Oklahoma
city: Duncanville
country: United States
facility: ELIOS Vision Clinical Site
state: Texas
city: El Paso
country: United States
facility: ELIOS Vision Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Elios Vision Clinical Site 2
state: Texas
city: San Antonio
country: United States
facility: ELIOS Vision Clinical Site
state: Texas
city: Kenosha
country: United States
facility: ELIOS Vision Clinical Site
state: Wisconsin
Study officials:
affiliation: Prism Eye Institute
name: Iqbal (Ike) Ahmed, MD
role: STUDY_DIRECTOR
References: