This content is only available for ASCRS Members
This content from the 2020 ASCRS Virtual Annual Meeting is only available to ASCRS members. To log in, click the teal "Login" button in the upper right-hand corner of this page.
Filed Under
Glaucoma
MIGS
trabeculotomy
trabecular microbypass stent
stent
iStent inject
2020 paper presentation
Purpose
To prospectively evaluate long-term performance of 2nd generation trabecular micro-bypass stents (iStent inject®) implanted as a standalone procedure in patients with open-angle glaucoma (OAG) not controlled by 1 ocular hypotensive medication.
Methods
This 5-year controlled, prospective, single-arm study enrolled subjects with OAG and preoperative intraocular pressure (IOP) of 18-30 mmHg on 1 medication (med) and 22-28 mmHg after washout. All subjects underwent implantation of iStent inject stents as a standalone procedure. Assessments through Month 60 (M60) included IOP, med burden, adverse events (AEs), best-corrected visual acuity (BCVA), visual fields (VF), cup-to-disc ratio (C:D), and findings from slit-lamp, gonioscopy, and fundus/optic nerve examinations.
Results
All 57 subjects underwent successful standalone iStent inject implantation and completed M60 follow-up. Preoperatively, mean IOP on a single med was 19.5±1.5 mmHg and unmedicated (post-washout) IOP was 24.4±1.3 mmHg. At all visits through M60, mean IOP was ≤14.6 mmHg. At M60, mean IOP was 12.9 mmHg (34% and 47% reduction vs preoperative medicated and unmedicated IOPs, respectively; p<0.0001 for both). At M60, of med-free eyes, 91% achieved unmedicated IOP ≤18 mmHg and 91% had IOP reduction ≥20% vs preoperative washout IOP. All but 4 eyes were med-free at M60. Favorable safety included no intraoperative or device-related AEs, BCVA 20/40 or better in 93% of eyes, and stable C:D and VF.
Conclusion
In OAG eyes with IOP not controlled on 1 med, standalone iStent inject implantation resulted in significant, sustained, and safe IOP and med reductions through 5 years postop with most eyes med-free. This favorable benefit-to-risk profile of standalone iStent inject implantation adds to existing evidence of the device’s safety and efficacy.
To prospectively evaluate long-term performance of 2nd generation trabecular micro-bypass stents (iStent inject®) implanted as a standalone procedure in patients with open-angle glaucoma (OAG) not controlled by 1 ocular hypotensive medication.
Methods
This 5-year controlled, prospective, single-arm study enrolled subjects with OAG and preoperative intraocular pressure (IOP) of 18-30 mmHg on 1 medication (med) and 22-28 mmHg after washout. All subjects underwent implantation of iStent inject stents as a standalone procedure. Assessments through Month 60 (M60) included IOP, med burden, adverse events (AEs), best-corrected visual acuity (BCVA), visual fields (VF), cup-to-disc ratio (C:D), and findings from slit-lamp, gonioscopy, and fundus/optic nerve examinations.
Results
All 57 subjects underwent successful standalone iStent inject implantation and completed M60 follow-up. Preoperatively, mean IOP on a single med was 19.5±1.5 mmHg and unmedicated (post-washout) IOP was 24.4±1.3 mmHg. At all visits through M60, mean IOP was ≤14.6 mmHg. At M60, mean IOP was 12.9 mmHg (34% and 47% reduction vs preoperative medicated and unmedicated IOPs, respectively; p<0.0001 for both). At M60, of med-free eyes, 91% achieved unmedicated IOP ≤18 mmHg and 91% had IOP reduction ≥20% vs preoperative washout IOP. All but 4 eyes were med-free at M60. Favorable safety included no intraoperative or device-related AEs, BCVA 20/40 or better in 93% of eyes, and stable C:D and VF.
Conclusion
In OAG eyes with IOP not controlled on 1 med, standalone iStent inject implantation resulted in significant, sustained, and safe IOP and med reductions through 5 years postop with most eyes med-free. This favorable benefit-to-risk profile of standalone iStent inject implantation adds to existing evidence of the device’s safety and efficacy.
View More Presentations from this Session
This presentation is from the session "SPS-105 Minimally Invasive Glaucoma Surgery: Viscocanalostomy, Combined Procedures, Outcomes" from the 2020 ASCRS Virtual Annual Meeting held on May 16-17, 2020.