SPS-105 Minimally Invasive Glaucoma Surgery: Viscocanalostomy, Combined Procedures, Outcomes | ASCRS
2020 ASCRS Virtual Annual Meeting

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Papers in This Session
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12-Month Outcomes for an Ab Interno Gelatin Stent Combined with Cataract Surgery or Utilized Standalone in Pseudophakic Eyes with Glaucoma
Authors
Peyton A. Rather
Steven D. Vold, MD
Mike R. McFarland, OD, MS

Purpose
To provide safety and effectiveness outcomes at 12 months post-surgically for the ab interno transscleral gelatin stent in patients with advanced glaucoma refractory or intolerant of medical therapy.

Methods
All patients implanted with the gelatin stent either combined with cataract surgery or as a solo procedure between February 2017 and April 2018 and meeting eligibility criteria were included. Outcome measures included proportion of patients achieving a 20% reduction in intraocular pressure (IOP), proportions at or below 12, 15, and 18 mmHg, IOP, medication usage, needling rate, and adverse events.

Results
The study included 92 eyes of 69 patients. Mean preoperative IOP and medications were 16.6 mmHg on 2.1 medications. Average visual field mean deviation was -13.7 dB. Half (48%) of the patients achieved the primary endpoint of 20% reduction while medication use decreased by -1.7 medications. The majority of patients at 12 months had IOP ≤ 18 mmHg on zero medications (74%) while 34% were medication free and had IOP ≤ 12 mmHg. Bleb needling was required for only 14% of patients. There were few adverse events (13% of eyes), the most common being BCVA loss and hyphema.

Conclusion
Eyes with advanced glaucoma despite maximum tolerated medical therapy can achieve lower target IOP on fewer medications following implantation with the gelatin microstent.
Hemi-Gonioscopic-Assisted Transluminal Trabeculotomy Combined with Direct Ab-Interno viscoelastic Canaloplasty
Authors
Gavin S. Docherty, FRCSC
Patrick Gooi, MD

Purpose
To describe a novel minimally invasive surgical technique for treatment of open-angle glaucoma. Initial papers describe gonioscopic-transluminal trabeculotomy as a circumferential procedure. The authors describe a novel procedure with 180-degree trabeculotomy followed by viscoelastic canaloplasty (viscocanaloplasty).

Methods
This was a pilot project describing initial results in a small case series (n=8) of patients undergoing hemi-gonioscopic-assisted transluminal trabeculotomy (Hemi GATT) with direct viscocanaloplasty.

Results
This was a pilot project (n=26) of patients undergoing hemi-gonioscopic-assisted transluminal trabeculotomy (Hemi GATT) with direct viscocanaloplasty. The mean age was 69 years (Range 24-87). Preoperatively the mean intraocular pressure (IOP) was 16 mmHg (Range 7-37) and patients were on an average of 2.8 IOP lowering drops. Average daily dose of diamox was 466mg (n=11). IOP lowering was significantly lower at 6 months follow up (p=0.05) with a mean IOP of 13 mmHg. IOP lowering medications were reduced significantly to an average of 1.6. Only one patient remained on diamox (375 mg daily). One patient developed CME and two patients had IOP spikes that were managed medically.

Conclusion
The results suggest that Hemi-GATT with direct viscocanaloplasty provides significant reductions in IOP as well as reduces reliance on oral diamox and topical IOP lowering medications. Ongoing evaluation is required to establish safety and efficacy especially when compared to hemi-GATT alone or circumferential GATT.
Efficacy of Combined Viscocanalostomy and Trabeculotomy at Lowering IOP at the Time of Cataract Surgery.
Authors
Jonathan M. Davidorf, MD, ABO
Oliver A. Davidorf

Methods
This prospective study will comprise 50 eyes undergoing combined cataract surgery/Omni. The preoperative and postoperative IOP and number of ocular anti-hypertensive medications will be recorded. Eyes will be stratified according to their preoperative IOP (<20mmHg, 20-25mmHg, >25mmHg). Data will be analyzed for the 1M, 3M, 6M, 12M, 24M visits.

Results
To date 18 eyes have been treated with a follow-up of 30 days or more. Mean pre-op IOP and number of medications is 18.7+/-4.1mmHg and 1.0+/-1.0 respectively. Mean postoperative IOP at 1M and 3M is 16.9+/-3.0mmHg and 14.8+/-2.2mmHg, respectively. All eyes were on the same or fewer number of IOP lowering medications at both postop intervals. Mean reduction in IOP is -1.8+/-3.6mmHg (-9 to +3mmHg) at 1M and -5.3+/-4.8mmHg (-11 to +1mmHg) at 3M.

Conclusion
The data suggests that combined viscocanalostomy/trabeculotomy performed at the time of cataract surgery has a tendency to significantly lower eye pressure (p=0.009 at 3M) and that the effect is stronger at 3M compared to 1M postoperatively. Longer follow-up on more eyes is needed to help assess the longer term efficacy of this new technique.
Sustained 5-Year Safety and IOP Outcomes in Open-Angle Glaucoma Subjects Treated with Trabecular Micro-Bypass Stents (iStent inject)
Author
Richard L. Lindstrom, MD

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.
6 Months Results of Patients with Poag and PEX-Glaucoma Treated with the Omni Surgical System As a Standalone Procedure
Author
Karsten Klabe, MD

Purpose
In this prospective 24-month single study assesses the safety and efficacy of OMNI720 Surgical System as a Standalone Procedure. The drug consumption, intraocular pressure and secondary surgical procedures required to control intraocular pressure are analyzed during the follow-up of at least 24 months after the OMNI procedure period.

Methods
In this data collection were recorded Ocular Medical Assessment, BCVA, Slit LampExam, IOPvia Applanation Tonometry, Gonioscopy, Fundus Exam, Nerve Abnormality Assessment, Optic Nerve Head Imaging, C/D Ratio, Visual Field Pachymetry and Endothelial cell morphology. Screening visit, subsequent wash-out phase (1d-48d) and baseline (IOP [9: 00; 12: 00; 15: 00]) before surgery. Follow-up visits 1 day, 1 week, 1 month, 3 month,6 month, 9 months, 12 months, 18 months , 18 months and 24 months after surgery are planned.

Results
Currently we have investigated 20 patients in a period of 6 months after surgery. We have a constant BCVA and the medication has been reduced by about 80%. The IOD (baseline) without medication has fallen by half on average. The complications were hyphema, tyndal cells and hyphosphagma.

Conclusion
On the results after six month, the IOP decline and the reduction of the drug is a success. For a long-term evaluation or recommendation more and especially longer data are necessary
My First 75 Cases – Real World Results from an Experienced U.S. Surgeon for a Schlemm’s Canal Microstent
Authors
Steven D. Vold, MD
Mike R. McFarland, OD, MS
Peyton A. Rather
Alnaserbelh AlNaseri, MBBS, COA
David P. Hurd, OD

Purpose
The FDA approved the Hydrus Microstent in August, 2018 for treatment of primary open angle glaucoma (POAG) in combination with cataract surgery. This paper presents the results of the first 75 commercial cases performed by an experienced surgeon on U.S. patients. Results are compared with those from the pivotal study.

Methods
Single surgeon, single site, retrospective chart review. The first 75 consecutive cases meeting eligibility criteria were reviewed by an independent observer. Outcomes measured include demographics, surgical parameters, IOP, number of hypotensive medications, and adverse events.

Results
Preliminary data consisting of 20 eyes from 13 patients were analyzed. Baseline mean IOP was 18.55 mmHg +/- 3.83 (SD) and mean number of glaucoma medications was 1.00 +/- 1.21. At 6 months mean IOP had dropped to 14.80 +/- 2.88 mmHg; P<0.01, and mean medications had reduced to 0.30 +/- 0.66; P<0.01. All Hydrus microstents were successfully implanted, with 100% success rate on the first attempt, and 100% were confirmed on gonioscopy to be properly positioned in Schlemm’s Canal at 1 week and 6 months postop. There were no cases of corneal edema or device migration. There were no persistent hyphema, iritis, IOP spike or any other adverse events beyond 1 month post-op.

Conclusion
Preliminary data suggest that the Hydrus Microstent was associated with clinically and statistically significant reduction in IOP and medication usage in the treatment of POAG.
24-Month Outcomes Following Transluminal Viscodilation of Schlemm’s Canal (ab-interno canaloplasty) for the Treatment of Open-Angle Glaucoma
Author
Mark J. Gallardo, MD

Methods
This was a single center, retrospective, non-randomized consecutive case series of eyes with POAG treated with ABiC as a stand-alone procedure or in conjunction with cataract extraction. Follow up visits were at 12 and 24 -months after surgery. The primary endpoints included mean IOP and mean number of glaucoma medications. Secondary endpoints included surgical and postsurgical complications and secondary interventions.

Results
The study included 60 eyes of 53 patients with a mean age of 73.6 ± 9.0 years. Baseline mean IOP was 20.7 ± 4.9 Hg on to 2.8 ± 0.9 medications. At 12 months after surgery, IOP and number of medications were statistically significantly (p<0.001) reduced to 13.6 ± 1.9 mmHg on 1.1 ± 1.1 medications. At 24 months after surgery, IOP was stable at 13.5 ± 2.6 mmHg on a slightly higher number of medications (1.7 ± 1.3). At 24-months, there was a mean IOP reduction of 34.8%, and a mean reduction in medications of 38.6%, and there was no difference in percentage reduction in IOP and in percentage reduction in medications between eyes that received ABiC alone and eyes that received combined treatment (p>0.05). However, the percentage reduction in medications was higher in the combined group (46.5%) than in the stand-alone group (31.4%). No serious adverse events were recorded.

Conclusion
These data demonstrate that ABiC was safe and efficient in reducing IOP and medication use over a 24-month follow-up in eyes with POAG treated with ABiC as a standalone procedure or with ABiC combined with cataract surgery.
Safety and Efficacy of a Minimally Invasive Glaucoma Surgery Device Combining Viscocanalostomy and Transluminal Trabeculotomy
Authors
Shamik Bafna, MD
Kathleen J Jee, MD
Tanner J. Ferguson, MD
William F. Wiley, MD

Purpose
To evaluate the safety and efficacy of the OMNI Glaucoma Treatment System (Sight Sciences), a minimally invasive glaucoma surgery device combining viscodilation and trabeculotomy in eyes with open-angle glaucoma.

Methods
Retrospective chart review of 50 patients undergoing combined viscodilation and trabeculotomy for mild to moderate open-angle glaucoma were evaluated at a single center. Primary outcome measures included intraocular pressure (IOP) and number of glaucoma medications. Data was collected preoperatively and postoperatively at months 1 and 3. Safety was assessed by noting the need for secondary glaucoma procedures.

Results
Mean pre-operative IOP was 15.6 mmHg on 1.3 IOP-lowering medications. At post-operative month 1, mean IOP decreased to 15.0 mmHg. By post-operative month 3, mean IOP decreased to 14.1 mmHg on 0.6 IOP-lowering medications. No secondary glaucoma procedures were required. Data will be updated prior to presentation at the ASCRS 2020 meeting.

Conclusion
The results of this study suggest the OMNI surgical system combining viscodilation and trabeculotomy is a safe and effective treatment option for eyes with open-angle glaucoma.
Unique MIGS Combining Goniotomy and Direct Viscodilation of the Collector Channels in Eyes with Laser Peripheral Iridotomies.
Authors
Linda L. Burk, MD
Jane E. Gilmore, MS, MD
Linda L Gilmore

Purpose
The purpose was to evaluate Dual Blade Goniotomy and Direct Viscodilation of the collector channels in eyes with previous peripheral iridotomies for narrow angle glaucoma. Could the “clean the gutter and power wash the downspout” procedure effectively open the once aggravated trabecular meshwork?

Methods
After standard cataract surgery, 30 eyes had 180 degrees of trabecular meshwork removed with the Kahook Dual Blade exposing the ostium of the collector channels allowing direct visco-dilation of the collector channels. Viscoelastic was injected into the collector channels as the cannula was snuggly held perpendicularly against the outer wall and dragged through the opened Schlemm’s canal. Viscoelastic was used to break any anterior synechiae.

Results
53% were African American. 73% were women.The average age was 68 years. 50% had moderate or advanced glaucoma. 53% were diabetics. 30% were on anticoagulants. Before surgery, the IOP was 21.7 mm HG (SD+/- 7.5) on 1.7 drops. At 3 months, the IOP was 14.7 mm HG (SD +/-3.8) on 0.2 eye drops. This was consistent throughout the first year except for a spike 17.1 mm HG (SD=/- 4.9) at 9 months which decreased to 15.5 mm HG (SD =/- 4.5) on 0.2 meds at 12 months. A blush of blood was seen over the trabecular meshwork was common in the angle but was gone in two weeks. Avascular fibrosis was seen in several eyes and removed with the Dual Blade when the trabecular meshwork had been identified.

Conclusion
Narrow angles previously treated with laser iridotomies can be successfully treated with the Goniotomy-Visco-dilation-Cataract Surgery technique. This “clean the gutter and powerwash the downspouts” approach demonstrates that the once aggravated trabecular meshwork can be cleaned, improving IOP control and reducing the amount of drops required.
Hybrid MIGS Technique: Dual Blade Goniotomy and Direct Viscodilation of the Collector Channels with Cataract Surgery: 18 Months Results
Authors
Linda L. Burk, MD
Jane Gilmore, MS, MD
Linda L Gilmore

Purpose
The purpose is to evaluate a hybrid MIGS procedure using Goniotomy and Direct Viscodilation of the collector channels with cataract surgery in all levels of glaucoma. This unique technique called "clean the gutter and power wash the downspouts", not only removes the trabecular meshwork but also directly viscodilates the collector channels.

Methods
After cataract surgery, the Dual Blade removed 180° of trabecular meshwork. Viscoelastic was injected into the exposed ostium of the Collector Channels as the perpendicular viscoelastic cannula was held firmly against the outer wall and dragged through the gutted canal. Moderate to severe glaucoma comprised 50% of the 120 eyes at 1 year. 33% had previous glaucoma surgery. 80% were African American. 50% were diabetics. 50% were on an anticoagulant.

Results
Initial IOP was 18.8mmHg(SD+/-5.4)on 1.7 medications. At 3 months the IOP was 15.8mmHg(SD+/-4.7). Throughout the first year the IOP hovered around 16.5mmHg. IOP then settled to 16.2mmHg (SD+/-3.9) in 70 of the 120 eyes that were seen for 18 months. At one year, 42% of all eyes had IOP ≤15mmHg on NO eye drops. The moderate to severe group had 9% more eyes ≤15mmHg than the mild group. medications were reduced by 1.5 drops per eye. Although the IOP was reduced by 15%, 90% of the eyes had all drops stopped. 91% of all drops were eliminated, a total of 200 bottles of drops per month or 2400 bottles per year. Considering $50 per bottle of drops, these 120 eyes just saved $120,000 this year.

Conclusion
The synergy of Goniotomy and Viscodilation markedly reduces drops even in advanced glaucoma with 46% of eyes achieving an IOP ≤15mm Hg, thus improving compliance and reducing the associated financial burden. The Goniotomy-Viscodilation-Cataract technique addresses both trabecular outflow resistance and salvages the collapsed collector channels.
Evaluation of Endothelial Cell Density and Loss Following Itrack Ab-Interno Canal Based Surgery
Authors
David M. Lubeck, MD, ABO
Inder P. Singh, MD
Robert J. Noecker, MD, MBA, ABO

Methods
Prospective, multi-center registry study with patients undergoing iTrack ab-interno canal based surgery, either as a standalone procedure or in combination with cataract surgery. Specular microscopy was performed preop and at 1, 6, 12, 24, and 36 months postop. Standard metrics for glaucoma surgery follow-up were also measured including; visual acuity, IOP, visual fields, optic nerve OCT and glaucoma medication use. Endothelial cell density and loss were analyzed at each time point. Results from patients undergoing iTrack combined with cataract surgery were compared with results from age matched controls who underwent cataract surgery only. Six month results are being reported.

Results
Mean endothelial cell loss 1 month following iTrack surgery was 4%, 2% as a standalone procedure and 5% in combination with cataract surgery. Endothelial cell loss in the age matched control group undergoing cataract surgery alone was 5%. There was no additional endothelial cell loss between months 1 and 6 in any group.

Conclusion
iTrack canal based surgery causes minimal endothelial cell loss, comparable to cataract surgery alone. Future analyses will assess longer term endothelial cell stability.
Initial Outcomes of Combined Phaco with Endocyclophotocoagulation with and without Ab Internotrabeculotomy in Open Angle Glaucoma
Authors
Juan Carlos Izquierdo, MD
Consuelo Gajardo Menzel, MD
Natalia Agudelo, MD
Jorge Camargo, MD
Katia Ruiz-Montenegro Villa, MD
Mirel Rincon, MD

Purpose
To evaluate and compare the efficacy and safety of combined phacoemulsification and endocyclophotocoagulation with and without ab interno trabeculotomy in patients with uncontrolled open angle glaucoma.

Methods
This comparative non-randomized retrospective study evaluated the 12-month outcomes of patients with uncontrolled open angle glaucoma who underwent combined phacoemulsification with endocyclophotocoagulation (ECP) and ab interno trabeculotomy (group I) vs phacoemulsification with endocyclophotocoagulation (group II). The primary outcome was mean preoperative and postoperative intraocular pressure; the secondary outcomes included the reduction in number of glaucoma medications, visual acuity, reported complete, qualified success or failure, and complications.

Results
Forty-six eyes of 36 patients were included; intraocular pressure was 16.96±3.66 mmHg and 15.64±4.88 mmHg for group I and group II (p=0.122) respectively at baseline, and 11.44±2.15 mmHg and 12.45±1.90 mmHg, respectively (p=0.031) at the 12-month follow-up. The complete success rate was 56% in group I and 55% in group II; the qualified success was 93% (p=0.011) and 91% (p=0.011), respectively. Medications decreased from 2.0±1.4 to 0.8±1.0 (p<0.001) in group I and 1.5±1.3 to 1.0±1.5 in group II (p=0.032). There was similar improvement in visual acuity in both groups. Complications were mild and resolved without intervention.

Conclusion
Both procedures achieved efficient and safe reduction in IOP as observed in patients with uncontrolled open angle glaucoma at 12-month follow-up. When ab interno trabeculotomy is added to phacoemulsification and ECP, the mean intraocular pressure is more greatly reduced, and this difference between the interventions is clinically significant.

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