Open Angle Glaucoma
Conditions
Brief summary
The primary objective of this study is to evaluate the safety, efficacy, and performance of the Suprachoroidal Dissection Instrument in creating a fistula between Schlemm's canal and the suprachoroidal space in refractory, open angle glaucoma subjects.
Detailed description
The Suprachoroidal Dissection Instrument (SDI) is a manually operated surgical instrument designed for use within Schlemm's canal. The instrument can access Schlemm's canal through a small ab-externo dissection, allowing use in eyes with scarring due to previous surgery or trauma.
Interventions
DEVICESuprachoroidal Dissection Instrument (SDI)
The Suprachoroidal Dissection Instrument (SDI) is a manually operated, non-powered, re-usable ophthalmic surgical instrument. The SDI is designed to enter a surgically exposed Schlemm's canal and be advanced up to 90 degrees around the canal from the entry site.
Sponsors
iScience Interventional Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Available for up to 3 years follow-up. * Diagnosed with primary open-angle, pseudoexfoliative, or pigmentary glaucoma or more than one glaucoma diagnosis of these types. * Subject scheduled to undergo glaucoma surgery with the Suprachoroidal Dissection Instrument involving creation of fistula between Schlemm's canal and the suprachoroidal space without combined cataract surgery. * Subject has failed at least one incisional glaucoma surgery (trabeculectomy, tube shunt, deep sclerectomy, viscocanalostomy, canaloplasty) or angle surgery (Trabectome) OR Is not a candidate for conventional glaucoma surgery due to reasons such as the presence of scleral buckle or compromised conjunctiva. * Subject has IOP ≥ 16 mm Hg on maximally tolerated medications within the six week (-42 days) period prior to surgery. * Visual field defect defined as mean deviation (MD) score worse than or equal to -10 dB on the Swedish Interactive Threshold Algorithm \[SITA\] Standard 24-2 Humphrey Analysis during the 6 month period prior to surgery. OR Subject has vertical cup-to-disk ratio ≥ 0.75 during the 6 month period prior to surgery.
Exclusion criteria
* Significant lens opacities or patient is candidate for cataract surgery during the duration of the study. * The patient had developmental glaucoma or a secondary glaucoma including steroid-induced, uveitic, or neovascular glaucoma (with the exception of pigmentary and pseudoexfoliative glaucoma). * The patient has narrow angle component possibly associated with glaucoma in the operative eye. * The subject has angle recession in the operative eye. * Significant ocular disease other than glaucoma affecting the assessment of visual function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative intraocular pressure, glaucoma medication usage, and visual acuity | 12 months |
Countries
United States
Outcome results
None listed