Open angle glaucoma and optic nerve rim and retinal nerve fiber layer loss with related visual field defects Glaucoma, surgery
Conditions
Interventions
Investigators will first perform the cataract surgery as normal. If this is
successful, they will then proceed to treat glaucoma according to the surgical
treatment that has been randomly selected f
the injectors is repositioned at
another location to implant a second iStent. Finally, the injector is removed
and surgery is completed as per standard procedure. The iStent is meant t
Sponsors
ELIOS Vision Inc.
Elios Vision Inc. became a wholly owned subsidiary of Bausch& Lomb (B+L)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 = 22 mmHg and = 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. a. A cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level on the pattern deviation (PD) plot; b. Glaucoma hemi-field test *outside normal limits* 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
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 • BCVA of 20/200 or worse in the study eye due to glaucoma. • Subjects with severe glaucoma, defined as visual field (VF) mean deviation (MD) of -12 or worse or 50% of points (i.e., 2 or more) within central 5 degrees with sensitivity of < 0 dB on the dB plot; NOTE : in the wash out phase no glaucoma medications are allowed 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 Visit, or anticipated) that may cause an increase in IOP (e.g., systemic steroidsi ncluding inhaled steroids used on a regular basis); 21. Inability to discontinue use of anticoagulation therapy in accordance with surgeon*s standard postoperative instructions; 22. Uncontrolled systemic disease that in the opinion of the Investigator would place the subject*s health at risk and/or prevent the subject from completing all study visits; 23. Current participation or participation in another investigational drug or device clinical trial (which
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoints are: • Mean change in post-washout diurnal IOP from baseline to 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary effectiveness endpoints are: • Percentage of patients achieving 20% reduction in post-washout diurnal IOP from baseline. • Mean change in number of hypotensive medications from screening to 12 months (month 11 visit before initiation of washout) • Mean change in treated IOP from screening to 12 months (month 11 visit before initiation of washout) • Proportion of patients with 0 medications (Medication free) at 12 months (month 11 visit before initiation of washout) | — |
Countries
Belgium, France, Germany, Netherlands, Spain, United Kingdom
Contacts
Public ContactGP Pellouin
Medevise Consulting
Outcome results
None listed