A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Effectiveness of ELIOS Compared to iStent inject W in Patients with Open-Angle Glaucoma Undergoing Cataract Surgery

• Conditions: Open angle glaucoma and optic nerve rim and retinal nerve fiber layer loss with related visual field defects; 10018307

• Registration Number: NL-OMON56815
• Lead Sponsor: ELIOS Vision Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

Patients are eligible for inclusion in this clinical trial if all the following
criteria apply. Ocular criteria pertain to the study eye only.
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
a. Glaucomatous optic nerve damage as evidenced by any of the following optic
disc or retinal nerve fiber layer structural abnormalities:
i. Diffuse thinning, focal narrowing or notching of the optic disc rim,
especially at the inferior or superior poles with or without disc hemorrhage;
ii. Localized abnormalities of the peripapillary retinal nerve fiber layer,
especially at the inferior or superior poles; or
iii. Optic disc neural rim asymmetry of the two eyes consistent with loss of
neural tissue
b. Cup-to-disc (C/D) ratio < 0.9
4. Visually significant cataract eligible for phacoemulsification;
5. Clear cornea on biomicroscopy.
6. Unmedicated (washout) mean diurnal IOP >= 22 mmHg and <= 34 mmHg at Baseline
visit;
7. Trabecular meshwork visible on gonioscopy, with Shaffer angle grade >= II in
all quadrants;
8. Presence of glaucomatous field defect with a mean deviation not worse than
-12 dB on a reliable, interpretable visual field examination using Humphrey
SITA Standard 24-2 visual hemifield analysis.
Note: The Humphrey VF should be reliable, defined as fixation
losses, false positives, and false negatives all less than 33%;
9. Sufficient cognitive awareness and willingness to follow study instructions,
agreed compliance with all study procedures, and willingness and ability to
return for all scheduled examinations for 24 months postoperatively;
10. Ability to provide written informed consent.

Exclusion Criteria

A subject who meets any of the criteria listed below will be excluded from the
study. Ocular criteria pertain to the study eye only unless otherwise
specified.
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 (e.g., argon laser trabeculoplasty [ALT], non-laser
retinal surgery, cyclodestructive procedure, scleral buckling procedure,
silicone oil use, etc.) with the exception of SLT occurring a minimum of 6
months prior to the Screening visit;
5. Prior iridectomy or laser iridotomy;
6. Clinically significant previous trauma to the eye, including chemical burn;
7. Subjects who cannot undergo a medication *washout* in the study eye or who
are at high risk for adverse outcomes, as determined by the investigator,
including:
• Subjects requiring oral ocular hypotensive medication (e.g., acetazolamide)
for IOP control or subjects
• Severe glaucoma in the fellow eye, defined by:
o On pattern deviation (PD) plot, having greater than or equal to 75% of points
depressed below the 5% level and greater than or equal to 50% of points
depressed below 1% level; or
o Having at least 50% of points (i.e., 2 or more) within central 5 degrees with
sensitivity of < 0 dB on the dB plot; or
o Having points within the central 5 degrees of fixation with sensitivity < 15
dB in both hemifields on the dB plot
• Subjects with BCVA of 20/200 or worse in the study eye due to glaucoma
• With fixation-threatening glaucoma in either eye noted at the Screening
Visit: Subjects with visual field defects threatening fixation defined as any
(1 or more) point(s) within the central 5° depressed below the 5th percentile
on PD plot unless this/these points are >25 dB on Threshold Values (decibel)
plot
8. Clinically significant ocular inflammation or infection within 30 days prior
to the Screening visit (e.g., blepharitis, conjunctivitis, keratitis);
9. Previous or current diagnosis of ophthalmic herpes simplex virus;
10. History of corneal surgery (including corneal refractive surgery), visually
significant corneal opacities, active inflammation, or any corneal
disease/pathology (e.g., Fuchs* dystrophy);
11. Presence of peripheral anterior synechiae (PAS) or other angle
abnormalities in the area of intended treatment;
12. Rubeosis;
13. Iridocorneal endothelial syndrome;
14. Epithelial or fibrous downgrowth;
15. Presence of extensive iris processes that obscure visualization of the
trabecular meshwork in area to be treated with laser;
16. Previous diagnosis of chronic or recurrent uveitis;
17. Active diabetic retinopathy, choroidal or iris neovascularization, branch
retinal vein occlusion, central retinal vein occlusion, proliferative
retinopathy, or other ophthalmic disease or disorder that could confound study
results;
18. Diagnosed degenerative visual disorders (e.g., macular degeneration or
other retinal disorders);
19. Known corticosteroid responder;
20. Use of systemic medications (either current, within 30 days of the
Screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified