SPS-314 Minimally Invasive Glaucoma Surgery: Surgical Outcomes | ASCRS
2020 ASCRS Virtual Annual Meeting

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Papers in this Session
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Gonioscopy-Assisted Transluminal Trabeculotomy (GATT) with and without Concomitant Cataract Surgery in Young and Middle-Aged Adults
Authors
Ali Salimi, MSc
Huda Al-Farsi, MD
Hady Saheb, MD, MPH

Purpose
Gonioscopy-assisted transluminal trabeculotomy (GATT) has been shown to reduce intraocular pressure (IOP) and medication use in open angle glaucoma (OAG) and congenital glaucoma; however, evidence in young and middle-aged adults remains limited. Here we report the outcomes of GATT with and without cataract surgery in young and middle-aged patients.

Methods
In this retrospective case series, eyes of patients between 18 and 65 years of age that underwent GATT were included. Success was defined as IOP ≤21mmHg with a reduction ≥20% compared to baseline and absence of additional glaucoma surgery or loss of light perception. Changes in IOP, medication burden, and best-corrected visual acuity (BCVA) were assessed using generalized linear models. Safety measures included adverse events and complications.

Results
21 eyes of 18 patients with a mean age of 45.3±13.9 years and a minimum of 6-month follow-up (16 with one-year follow-up) were included. The 12-month survival was 81%. IOP decreased significantly from 28.6±10.5 mmHg to 13.1±3.7 (54% reduction, p<0.001) and 15.3±3.7 (47% reduction, p=0.004) at 6 and 12 months postoperatively, respectively. Medication use decreased from 3.6±1.1 to 1.3±1.2 (65% decrease, p<0.001) and 0.8±1.1 (78% reduction, p<0.001) at 6 and 12 months postoperatively, respectively. Common adverse events included transient postoperative hyphema in 13 eyes, IOP spike in 11 eyes (10 underwent anterior chamber tap), and corneal edema in 4 eyes. Postoperative BCVA remained stable.

Conclusion
Our data support the one-year safety and efficacy of GATT with and without concomitant cataract surgery in young and middle-aged adults with OAG. It is possible that the pathophysiology of OAG in younger patients is more localized to the trabecular meshwork, therefore making GATT a particularly suitable procedure for these patients.
Second-Generation Trabecular Microbypass Stent Implantation with Cataract Surgery: Early Clinical Experience
Authors
Tanner J. Ferguson, MD
Adam Bleeker
Zachary C. Dockter
Kayla L. Karpuk, OD
Mitch J. Ibach, OD
Justin A. Schweitzer, OD
John P. Berdahl, MD

Methods
Retrospective, consecutive case series from August 2018 to May 2019. The series was comprised of 72 eyes implanted with a trabecular microbypass stent with concomitant cataract surgery. Data was collected pre-operatively, and post-operatively at 1 day, 1 week, months 1, 3, 6, 12. Data included intraocular pressure and number of glaucoma medications. Safety was assessed by noting the incidence of postoperative IOP pressure spikes ≥15 mmHg and the need for additional surgery.

Results
At baseline, the mean IOP and number of medications was 19.3 ± 6.2 mm Hg and 1.6 ± 1.1, respectively. 12 months after surgery, pressure was reduced to 15.3 ± 3.8 mmHg and medications were reduced to 0.75 ± 0.45, indicating a >50% reduction in medication use. Postoperatively, no patients experienced an IOP increase ≥15 mmHg above their baseline IOP and no eyes underwent additional surgery.

Conclusion
Early clinical experience shows that insertion of the second-generation trabecular microbypass stent with cataract extraction provides effective IOP reduction and reduced medication burden in patients with open-angle glaucoma. The safety profile of the device is favorable with no intra- or postoperative complications.
Trabecular Microbypass Stent Implantation with Cataract Extraction in Open-Angle Glaucoma: 7 Year Results
Authors
John P. Berdahl, MD
Zachary C. Dockter
Adam Bleeker
Kayla L. Karpuk, OD
Justin A. Schweitzer, OD
Mitch J. Ibach, OD
Tanner J. Ferguson, MD

Methods
A retrospective review was conducted of 411 eyes with open-angle glaucoma. Data was collected pre-operatively, and postoperative data was collected at 1 day, 1 month out to 7 years postoperative. Data included intraocular pressure (IOP), number of glaucoma medications, the incidence of post-operative IOP pressure spikes of greater than ≥15mmHg at any time point, and need for additional surgery.

Results
The mean preoperative IOP was 18.8 ± 5.0 mmHg. At 7 years postoperative, mean IOP was 15.1 ± 2.0 mmHg (p<0.01). The mean number of glaucoma medications was 1.4 ± 1.0 pre-operatively and 1.2 ± 1.0 at 7 years postoperative. At 1-day post-operative, 10% of eyes experienced an IOP increase of 15 mmHg above their baseline IOP that responded to topical therapy. 16 patients required additional surgery; 6 were filtering procedures.

Conclusion
The insertion of the iStent trabecular micro-bypass stent in combination with cataract surgery provides a sustained pressure reduction in open-angle glaucoma patients. Medication use was reduced in the consistent cohort. The safety profile appears favorable with a low rate of IOP spikes and only <5% of eyes requiring additional surgery.
Second Generation Trabecular Micro-Bypass Stents (iStent inject) with Cataract Surgery in Normal Tension Glaucoma: One-Year Outcomes
Authors
Ali Salimi, MSc
Colin I. Clement, MD
Michael Shiu, FRANZCO
Paul J. Harasymowycz, MD

Purpose
Trabecular micro-bypass stents allow improved multidirectional flow with good efficacy and safety in primary open-angle glaucoma. However, their outcomes in normal tension glaucoma (NTG) has been understudied. Here, we assessed the one-year outcomes related to implantation of trabecular micro-bypass stents with concomitant cataract surgery in NTG.

Methods
We evaluated the baseline clinical characteristics and the 12-month outcomes of patients with mild to severe normal tension glaucoma who underwent cataract surgery with implantation of the second-generation trabecular micro-bypass stents (iStent inject). Success was defined as intraocular pressure (IOP) ≤15mmHg with a reduction ≥20% compared to baseline and absence of additional glaucoma surgery or loss of light perception. Changes in IOP, medication burden and best-corrected visual acuity (BCVA) were assessed at 12 months postoperatively using generalized linear models. Post-operative adverse events and complications were documented.

Results
A total of 42 eyes of 29 patients with an average age of 69.6±8.2 were included. All eyes had mild to severe NTG, 7 of which had prior selective laser trabeculoplasty. The 12-month success was 79%. At one-year follow-up, the IOP decreased by 25% from 15.5±2.9 to 11.5±2.4 mmHg (p< 0.001) and the medication burden dropped by 60% from 1.3±1.2 to 0.5±1.0 (p< 0.001) with 71% medication-free. In terms of safety, BCVA improved postoperatively by an average of 4 letters, visual field mean deviation remained stable (p=0.383), and only one patient experienced a transient and self-limiting IOP spike at 2 weeks postoperatively.

Conclusion
Our data support the efficacy and safety of iStent inject in eyes with mild to severe normal tension glaucoma, as evidenced by significant reductions in IOP and medication use, improved vision, as well as infrequent and self-limiting adverse events.
Long-Term Outcomes of Trabecular Bypass Stenting with Cataract Surgery Including VF, OCT and Disease Progression: Real-World Case Series
Author
Richard A. Lehrer, MD, ABO

Methods
This retrospective case series includes 220 OAG eyes implanted with iStent combined with cataract surgery. Although all eyes have been followed to at least 1year, a subset have follow-up data out to 5 years. Key data analyzed included IOP, medications, VF and/or OCT. Progression of disease was assessed by the surgeon using VF and/or OCT outputs.

Results
Mean preop IOP was 16.8±3.8 mmHg on 1.3±0.9 meds (n=220). 5-year mean postop IOP was 14.7±2.8 on 0.6±0.7 meds (n=35) (p<0.001, both IOP & meds, alpha 0.05). A consistent cohort of eyes reaching 3-years postop (n=132 eyes) was analyzed, which revealed similar outcomes (p<0.001, both IOP & meds). Progression of disease was subjectively determined by surgeon pre- and post-op VF and OCT outputs. Data was available for VF 147 eyes (mean 38 months postop); OCT 204 eyes (mean 36 months postop); combination of both VF and OCT 117 eyes. Non-progressor eyes comprised 90% eyes with VF; 93% eyes with OCT and 98% eyes with both VF and OCT. Favorable safety was observed with nonsignificant complications.

Conclusion
Efficacy, safety and VF and OCT outcomes of combined trabecular bypass stenting with cataract surgery was studied. Reduction of IOP and medications was sustained out to 5 years. VF and OCT were stable suggesting that treatment with iStent is able to maintain structure and function in glaucomatous eyes over several years.
Investigating Pre-Operative Factors That Predict Trabecular Meshwork Bypass Stent Outcomes
Authors
Jason S. Flamendorf, MD
Denis Huang
Marlene R. Moster, MD
Michael J Pro, MD
Jonathan S. Myers, MD, ABO
Daniel Lee, MD, ABO

Purpose
To investigate pre-operative factors that may predict successful outcomes with implantation of a trabecular meshwork bypass stent. Specific associations with prior response to selective laser trabeculoplasty (SLT) and intraocular pressure (IOP) change after pharmacologic dilation were examined.

Methods
A retrospective chart review study of patients who had iStent (Glaukos, San Clemente, CA) implantation in conjunction with cataract surgery between 2013 and 2018 was conducted. Patients were included if they had IOPs recorded before and after pharmacologic dilation on the same day or SLT prior to iStent surgery and 3 months postoperative follow-up. iStent success was defined as IOP reduction ≥20% from baseline without additional medications, or a reduction of at least one glaucoma medication with no increase in IOP, and without re-operation within 12 months after surgery. A successful response to SLT was defined as an IOP reduction of ≥20% from the pre-SLT IOP.

Results
Three hundred twelve eyes of 246 patients were enrolled with a mean follow-up time of 10.2 ± 3.8 months. There was a statistically significant decrease in IOP and mean number of glaucoma medications compared to baseline at 3, 6, and 12 months (p<0.001 for all comparisons). On univariate analysis, a greater baseline IOP (p=0.001) and prior laser peripheral iridotomy (p=0.031) were significantly associated with success at 12 months, and these remained significant in a logistic regression model. Prior response to SLT and IOP change after dilation were not statistically significant factors. A Cox proportional-hazards regression model did not reveal any statistically significant associations.

Conclusion
A higher baseline IOP is associated with successful response to iStent within the first 12 months, and a history of anatomical narrow angles with LPI does not impact iStent success.
Case Series of Trabecular Micro-Bypass Stents Implanted Inferiorly in Combination with Cataract Surgery
Authors
Tyler C. Goff, MD
Keith Walter, MD, ABO
Kirsten Wagner, MD

Methods
Medicated eyes w/ glaucoma were evaluated after they received iStent Inject implants that were placed in the inferior quadrant of the trabecular meshwork in combination with cataract surgery performed via superior approach. Effectiveness outcomes through the first year of follow up included IOP measurements and number of glaucoma medications. Secondary outcomes included, >20% reduction in pre-op medicated IOP and percentage of eyes who became medication free.

Results
The analysis included 14 patients and 19 eyes with cataract and mild to moderate glaucoma with no previous history of glaucoma or cataract surgery. At a mean follow up period of 143 days, the average IOP decreased from 18.8 ± 6.5 mmHg to 14.0 ± 2.4 (p-value <0.001) with an average reduction of 4.8 mmHg. The average number of medications decreased from 1.50 ± 0.52 to 0.50± 0.73 (p-value <0.001). 58% of eyes received greater than 20% reduction in IOP. Furthermore, 68% of eyes were medication free at last follow up. None of the eyes had significant intra-operative or post-operative complications.

Conclusion
The I-stent inject has proven to have a statistically significant reduction in IOP in previously medicated eyes in the real-world setting. Furthermore, we have proven the inferiorly implanted iStent inject® is able to reduce the number of glaucoma medications, and help a majority of patients become medication free.

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