Acknowledgments
413
Medical writing support, including preparation of manuscript drafts for critical revision and 414
approval by the authors in accordance with GPP3, was provided by Bethany Broughton, 415
MSc, Helios Medical Communications, Alderley Park, Cheshire, UK, which was funded by 416
Santen Inc., Emeryville, CA, USA. The study was sponsored by InnFocus Inc., a Santen 417
Pharmaceutical Co. Ltd. company, Miami, Florida. The authors would like to thank Santen 418
for their support in the development of this manuscript, and Tuan Nguyen for statistical 419
support and data analysis.
420
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References
421
1. El Hajj Moussa WG, Farhat RG, Nehme JC, et al. Comparison of efficacy and ocular 422
surface disease index score between bimatoprost, latanoprost, travoprost, and tafluprost in 423
glaucoma patients. J Ophthalmol 2018;2018:1319628.
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2. Jones JP, Fong DS, Fang EN, et al. Characterization of glaucoma medication adherence 425 in Kaiser Permanente Southern California. J Glaucoma 2016;25:22–26.
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3. Gedde SJ, Herndon LW, Brandt JD, et al. Postoperative complications in the Tube Versus 427 Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol 2012;153:804–
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4. Gedde SJ, Feuer WJ, Shi W, et al. Treatment outcomes in the Primary Tube Versus 430 Trabeculectomy study after 1 year of follow-up. Ophthalmology 2018;125:650–663.
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5. Gazzard G, Konstantakopoulou E, Garway-Heath D, et al. Selective laser trabeculoplasty 432
versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a 433 multicentre randomised controlled trial. Lancet 2019;393:1505–1516.
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6. Richter GM, Coleman AL. Minimally invasive glaucoma surgery: current status and future 435 prospects. Clin Ophthalmol 2016;10:189–206.
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7. Poley B, Lindstrom R, Samuelson T, Schulze RJ. Intraocular pressure reduction after 437
phacoemulsification with intraocular lens implantation in glaucomatous and 438
nonglaucomatous eyes: evaluation of a causal relationship between the natural lens and 439
open-angle glaucoma. J Cataract Refract Surg 2009;35:1945–1955.
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8. Pillunat LE, Erb C, Jünemann AG, Kimmich F. Micro-invasive glaucoma surgery (MIGS): a 441
review of surgical procedures using stents. Clin Ophthalmol 2017;11:1583–1600.
442
9. Grover DS, Flynn WJ, Bashford KP, et al. Performance and safety of a new ab interno 443
gelatin stent in refractory glaucoma at 12 months. Am J Ophthalmol 2017;183:25–36.
444
10. Marcos Parra MT, Salinas López JA, López Grau NS, et al. XEN implant device versus 445
trabeculectomy, either alone or in combination with phacoemulsification, in open-angle 446
glaucoma patients. Graefes Arch Clin Exp Ophthalmol 2019;257:1741–1750.
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11. Glaukos Announces Australia’s TGA Regulatory Approval for PRESERFLO™
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MicroShunt. 2021. Available from: http://investors.glaukos.com/investors/press-449
releases/press-release-details/2021/Glaukos-Announces-Australias-TGA-Regulatory-450
Approval-for-PRESERFLO-MicroShunt/default.aspx (Accessed 09 July 2021).
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12. Santen Announces Health Canada Approval of PRESERFLOTM MicroShunt. 2021.
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Available from: https://www.santenusa.com/pdfs/preserflo-microshunt-canada-approval.pdf 453
(Accessed 12 July 2021).
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13. Pinchuk L, Riss I, Batlle JF, et al. The use of poly(styrene-block-isobutylene-block-455 styrene) as a microshunt to treat glaucoma. Regen Biomater 2016;3:137–142.
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14. Pinchuk L, Riss I, Batlle JF, et al. The development of a micro-shunt made from 457
poly(styrene-block-isobutylene-block-styrene) to treat glaucoma. J Biomed Mater Res B Appl 458
Biomater 2017;105:211–221.
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15. Batlle JF, Fantes F, Riss I, et al. Three-year follow-up of a novel aqueous humor 460
microshunt. J Glaucoma 2016;25:e58–e65.
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16. ClinicalTrials.gov. NCT00772330. Clinical study of the safety and performance of the 462
Miami InnFocus Drainage Implant to relieve glaucoma symptoms. 2017. Available at:
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https://clinicaltrials.gov/ct2/show/NCT00772330 [Accessed August 6, 2020].
464
17. Shaarawy T, World Glaucoma Association eds. Guidelines on design and reporting of 465
glaucoma surgical trials. Amsterdam: Kugler; 2009.
466
18. Sanders SP, Cantor LB, Dobler AA, Hoop JS. Mitomycin C in higher risk trabeculectomy:
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a prospective comparison of 0.2- to 0.4-mg/cc doses. J Glaucoma 1999;8:193–198.
468
19. Al Habash A, Aljasim LA, Owaidhah O, Edward DP. A review of the efficacy of Mitomycin 469
C in glaucoma filtration surgery. Clin Ophthalmol 2015;9:1945–1951.
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20. Kakizaki H, Takahashi Y, Nakano T, et al. Anatomy of tenons capsule. Clin Exp 471
Ophthalmol 2012;40:611–616.
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21. Widder RA, Dietlein TS, Dinslage S, et al. The XEN45 Gel Stent as a minimally invasive 473
procedure in glaucoma surgery: success rates, risk profile, and rates of re-surgery after 261 474
surgeries. Graefes Arch Clin Exp Ophthalmol 2018;256:765–771.
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22. Fagerli M, Løfors KT, Elsås T. Needling revision of failed filtering blebs after 476 trabeculectomy: a retrospective study. Acta Ophthalmol Scand 2003;81:577–582.
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23. ClinicalTrials.gov. NCT01881425. InnFocus MicroShunt versus trabeculectomy study 478
(IMS). 2018. Available at: http://www.clinicaltrials.gov/ct2/show/NCT01881425 [Accessed 479
August 6, 2020].
480 481
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Figure Legends
482
Figure 1. Patient disposition.
483
IOP = intraocular pressure; POAG = primary open-angle glaucoma; PP = per-protocol.
484
aReasons for not meeting inclusion criteria included patients with an IOP <18 or >35 mmHg 485
at baseline (n = 7) and a type of glaucoma other than POAG (n = 3).
486
bReasons for meeting exclusion criteria included prior laser surgery in the last 90 days (n = 487
3), previous incisional surgery in the last 6 months (n = 2), and use of ocular hypotensive 488
medications in the fellow eye (n = 2).
489
cThe patients who did not receive the MicroShunt (n = 2) were included in the patients who 490
had no IOP score after month 6 (n = 3).
491
Figure 2. (A) Postoperative intraocular pressure (IOP) levels compared with preoperative 492
IOP at 2 years of follow up. The diagonal line represents a 20% reduction in mean IOP.
493
(B) Mean and median medicated IOP over 2 years of follow up (per-protocol population).
494
The upper and lower borders of the box indicate the 75th and 25th percentiles, respectively.
495
The whiskers indicate the maximum and minimum values. The horizontal line and white 496
symbol within each box indicate the median and mean, respectively.
497
Figure 3. Postoperative intraocular pressure (IOP) levels compared with preoperative IOP at 498
1 year of follow up (per-protocol population). The diagonal line represents a 20% reduction in 499
mean IOP. One patient had an IOP of 40 mmHg at year 1 because of an encapsulated bleb 500
(serious adverse event); this patient underwent reoperation of the study eye and, as a result, 501
discontinued the study shortly after year 1 (available at www.ophthalmologyglaucoma.org).
502
Figure 4. Success probabilities for the overall population according to intraocular pressure 503
(IOP) target range over 2 years of follow up (per-protocol population): (A) IOP ≥6 and <21 504
mmHg, (B) IOP ≥6 and <18 mmHg, (C) IOP ≥6 and <15 mmHg.
505
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aSuccess was assessed in all patients (N = 81); 44 patients had their Year 2 visit after day 506
730.
507
Figure 5. Mean (± standard deviation; SD) number of glaucoma medications per patient 508
over 2 years of follow up.
509
Figure 6. Percentage of patients without or with glaucoma medications at baseline, year 1, 510
and year 2 at each site (available at www.ophthalmologyglaucoma.org).
511
Figure 7. Mean and median medicated IOP over 2 years of follow up (per-protocol 512
population). Asterisk denotes statistical significance between the 0.2 mg/mL and 0.4 mg/mL 513
Mitomycin C (MMC) groups at month 6 (P = 0.038). The upper and lower borders of the box 514
indicate the 75th and 25th percentiles, respectively. The whiskers indicate the maximum and 515
minimum values. The horizontal line and white symbol within each box indicate the median 516
and mean, respectively.
517
Figure 8. Success probabilities for the 0.2 mg/mL Mitomycin C (MMC) concentration and 518
intraocular pressure (IOP) target range over 2 years of follow up (per-protocol population):
519
(A) IOP ≥6 and <21 mmHg, (B) IOP ≥6 and <18 mmHg, (C) IOP ≥6 and <15 mmHg.
520
aSuccess was assessed in all patients (N = 81); 44 patients had their Year 2 visit after day 521
730.
522
Figure 9. Success probabilities for the 0.4 mg/mL Mitomycin C (MMC) concentration and 523
intraocular pressure (IOP) target range over 2 years of follow up (per-protocol population):
524
(A) IOP ≥6 and <21 mmHg, (B) IOP ≥6 and <18 mmHg, (C) IOP ≥6 and <15 mmHg.
525
aSuccess was assessed in all patients (N = 81); 44 patients had their Year 2 visit after day 526
730.
527
Figure 10. The mean number of glaucoma medications ± standard deviation (SD) over time 528
in the 0.2 mg/mL and 0.4 mg/mL Mitomycin C (MMC) subgroups. Asterisk denotes statistical 529
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significance between the 0.2 mg/mL and 0.4 mg/mL MMC groups at month 6 (P = 0.003), 530
month 9 (P = 0.003), year 1 (P = 0.012), and year 2 (P < 0.001).
531
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I give permission for Prof. Dr, Henny J.M. Beckers, as corresponding author, to list my contribution in the acknowledgements section of the manuscript entitled ‘Safety and Effectiveness of the
PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study’
submitted to Ophthalmology Glaucoma.
___________________
Signature Tuan Nguyen
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Table 1. Patient Demographics and Baseline Characteristics (Per-Protocol Population)
Demographics and Baseline Characteristics
Overall Population (N = 81)
Age, years (mean ± SD) 64.4±12.2
Range 28–85
Male, n (%) 36 (44.4)
Lens status, n (%)
Phakic 55 (67.9)
Pseudophakic 26 (32.1)
Medicated IOP, mmHg (mean ± SD) 21.7±3.4
Range 18–33
IOP ≥18 and ≤21 mmHg, n (%) 45 (55.6)
IOP >21 mmHg, n (%) 36 (44.4)
Medicated IOP, mmHg (median [IQR]) 20.0 (4.5)
Number of glaucoma medications (mean ± SD) 2.0±1.3
Range 0–5
Number of glaucoma medications (median [IQR]) 2.0 (2.0)
VA, logMAR (mean ± SD) 0.12±0.17
Range -0.1–1.0
VA, logMAR (median [IQR]) 0.10 (0.15)
IOP = intraocular pressure; IQR = interquartile range; SD = standard deviation; VA = visual acuity.
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Table 5. Summary of Procedure- or Device-Related Non-Serious AEs (Occurring in ≥3% of
Patients) and All SAEs in the Study Eye on or before 2 Years of Follow Up (Per-Protocol Population)
AEs (Procedure- or Device-Related), n (%)
Overall Population (N = 81)
Timing of AEa Early (on or before month 1) Late (after month 1)
Patients with any non-serious AE 32 (39.5) 33 (40.7)
Increased IOP 3 (3.7)b 20 (24.7)b
Transient hypotony (<6 mmHg) 9 (11.1) 0 (0.0)
Keratitisc 5 (6.2) 4 (4.9)
Leakage of wound site based on Seidel test 3 (3.7) 0 (0.0)
Pain 3 (3.7) 1 (1.2)
Flat anterior chamber 2 (2.5) 0 (0.0)
Hyphema 2 (2.5) 0 (0.0)
Diplopia 0 (0.0) 1 (1.2)
Corneal abrasion during surgery 1 (1.2) 0 (0.0)
Complication of device insertion 2 (2.5) 0 (0.0)
Cataract 0 (0.0) 1 (1.2)
Device touching cornea 0 (0.0) 1 (1.2)
Patients with any SAE 3 (3.7) 3 (3.7)
Event requiring unplanned glaucoma-related
surgical reintervention 0 (0.0) 2 (2.5)
Keratitisd 1 (1.2) 0 (0.0)
Conjunctival dehiscence 1 (1.2) 0 (0.0)
Corneal ulcere 1 (1.2) 0 (0.0)
Increased IOP 0 (0.0) 1 (1.2)f
Leakage of wound site based on Seidel test 1 (1.2) 0 (0.0)
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AE = adverse event; IOP = intraocular pressure; SAE = serious adverse event.
aPatients who experienced multiple AEs are captured in both early and late categories depending upon the AE start date.
bFollowing the event of increased IOP, 9 patients received medication, 5 underwent surgical procedure, 3 received medication and surgical procedure, 2 underwent postsurgical injection of 5-fluorouracil, 2 underwent needling, 2 did not receive any intervention, and 1 received medication and needling. Some patients required multiple actions for increased IOP.
cOne patient had an IOP increase of ≥10 mmHg compared with baseline because of an encapsulated bleb.
dKeratitis is listed as an AE and an SAE depending upon the severity of the reaction. The patient with an SAE of keratitis required hospitalization and medication. Keratis as an AE is a mild-to-moderate reaction resolved with medication.
eCorneal ulcer was defined as an epithelial erosion and was recorded as an SAE owing to sponsor coding.
fFollowing the SAE of increased IOP, 1 patient received medication and underwent a surgical procedure.
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Table 6. Patient Demographics and Baseline Characteristics for the Mitomycin C (MMC)
Subgroup Analysis (Per-Protocol Population)
Demographics and Baseline Characteristics
0.2 mg/mL MMC (n = 32)
0.4 mg/mL MMC (n = 43)
P-value
Age, years (mean ± SD) 64.0±12.4 64.4±12.5 0.884
Male, n (%) 13 (40.6) 22 (51.2) 0.366
Lens status, n (%)
Phakic 24 (75.0) 28 (65.1) 0.359
Pseudophakic 8 (25.0) 15 (34.9)
Medicated IOP, mmHg (mean ± SD) 20.9±2.5 21.9±3.7 0.195
IOP ≥18 and ≤21 mmHg, n (%) 22 (68.8) 23 (53.5)
IOP >21 mmHg, n (%) 10 (31.3) 20 (46.5)
Medicated IOP, mmHg (median [IQR]) 20.0 (3.0) 20.0 (6.0) NA
Number of glaucoma medications (mean ± SD)
2.2±1.3 2.0±1.3 0.497
Number of glaucoma medications (median [IQR])
2.0 (2.0) 2.0 (2.0) NA
VA, logMAR (mean ± SD) 0.12±0.15 0.12±0.13 0.984
VA, logMAR (median [IQR]) 0.10 (0.10) 0.10 (0.15) NA
IOP = intraocular pressure; IQR = interquartile range; MMC = Mitomycin C; NA, not applicable; SD = standard deviation; VA = visual acuity.
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Table 8. Summary of Procedure- or Device-Related Non-Serious AEs (Occurring in ≥3% of
Patients) and All SAEs in the Study Eye on or before 2 Years of Follow Up (Per-Protocol Population)
AEs (Procedure- or Device-Related), n (%)
0.2 mg/mL MMC (N = 32)
0.4 mg/mL MMC
(N = 43) P-value
Timing of AE:a Early (on or before
month 1) Late (after month 1) Early (on or before month 1)
Late (after month 1)
Early (on or before
month 1) Late (after month 1)
Patients with any non-serious AE 5 (15.6) 11 (34.4) 24 (55.8) 18 (41.9) <0.001 0.633
Increased IOPb 2 (6.3) 9 (28.1) 0 (0) 10 (23.3)c
Transient hypotony
(<6 mmHg) 0 (0.0) 0 (0.0) 7 (16.3) 0 (0.0)
Keratitisd 0 (0.0) 1 (3.1) 5 (11.6) 3 (7.0)
Leakage of wound site based on
Seidel test 0 (0.0) 0 (0.0) 3 (7.0) 0 (0.0)
Pain 1 (3.1) 0 (0.0) 2 (4.7) 1 (2.3)
Flat anterior chamber 0 (0.0) 0 (0.0) 2 (4.7) 0 (0.0)
Hyphema 1 (3.1) 0 (0.0) 1 (2.3) 0 (0.0)
Diplopia 0 (0.0) 1 (3.1) 0 (0.0) 0 (0.0)
Corneal abrasion during surgery 1 (3.1) 0 (0.0) 0 (0.0) 0 (0.0)
Complication of device insertion 1 (3.1) 0 (0.0) 1 (2.3) 0 (0.0)
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Cataract 0 (0.0) 1 (3.1) 0 (0.0) 0 (0.0)
Device touching cornea 0 (0.0) 1 (3.1) 0 (0.0) 0 (0.0)
Patients with any SAE 1 (3.1) 1 (3.1) 2 (4.7) 2 (4.7) 1.000 1.000
Event requiring unplanned glaucoma-related surgical reintervention
0 (0.0) 1 (3.1) 0 (0.0) 1 (2.3)
Keratitisd 1 (3.1) 0 (0.0) 0 (0.0) 0 (0.0)
Conjunctival dehiscence 0 (0.0) 0 (0.0) 1 (2.3) 0 (0.0)
Corneal ulcere 0 (0.0) 0 (0.0) 1 (2.3) 0 (0.0)
Increased IOP 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.3)f
Leakage of wound site based on
Seidel test 0 (0.0) 0 (0.0) 1 (2.3) 0 (0.0)
AE = adverse event; IOP = intraocular pressure; MMC = Mitomycin C; SAE = serious adverse event.
aPatients who experienced multiple AEs are captured in both early and late categories depending upon the AE start date.
bFollowing the event of increased IOP, 9 patients received medication, 5 underwent surgical procedure, 3 received medication and surgical procedure, 2 underwent postsurgical injection of 5-fluorouracil, 2 underwent needling, 2 did not receive any intervention, and 1 received medication and needling. Some patients required multiple actions for increased IOP.
cOne patient had an IOP increase of ≥10 mmHg compared with baseline because of an encapsulated bleb.
dKeratitis is listed as an AE and an SAE depending upon the severity of the reaction. The patient with an SAE of keratitis required hospitalization and medication. Keratitis as an AE is a mild-to-moderate reaction resolved with medication.
eCorneal ulcer was defined as an epithelial erosion and was recorded as an SAE owing to sponsor coding.
fFollowing the SAE of increased IOP, 1 patient received medication and underwent a surgical procedure.
In total, 6 patients received 0.28 mg/mL of MMC; these patients were not included in the 0.2 or 0.4 mg/mL MMC analyses.
P-values were based on Fisher’s exact test and not adjusted for baseline glaucoma medications or multiplicity.
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Excluded (n = 6)
• Withdrew consent (n = 2)
• Excluded from study by investigator (n = 1)
• Excluded from study by sponsor (n = 1)
• Other reason (n = 2)
Included in PP population analysis (n = 81)
Underwent procedure (n = 101)
• Received MicroShunt (n = 99)
• Did not receive MicroShunt (n = 2)
Discontinued study (n = 11)
• Lost to follow up (n = 4)
• Adverse event (n = 3)
• Withdrew consent (n = 2)
• Excluded for medical reasons (n = 1)
• Died during study participation (n = 1)
Enrolled (n = 107)
Excluded from PP population (n = 20)
• Not meeting inclusion criteria (n = 10)a
• Meeting exclusion criteria (n = 7)b
• No IOP scores after month 6 (n = 3)c
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A
Mean IOP at Year 2 (mmHg)
B
IOP (mmHg)
0 10 20 30
0 10 20 30 40
Mean Baseline IOP (mmHg)
IOP = 21 mmHg IOP = 18 mmHg IOP = 14 mmHg
40
0 10 20 30
Baseline Day 1 Day 7 Week 4 Month 3 Month 6 Month 9 Year 1 Year 2
Visit
X
X X
X
X
X X X X
81 79 80 80 78 74 68 67 60
n =
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Figure 3. Postoperative intraocular pressure (IOP) levels compared with preoperative IOP at
1 year of follow up (per-protocol population). The diagonal line represents a 20% reduction in mean IOP. One patient had an IOP of 40 mmHg at year 1 because of an encapsulated bleb (serious adverse event); this patient underwent reoperation of the study eye and, as a result, discontinued the study shortly after year 1.
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Month 3 Month 6 Month 9 Year 1 Year 2
0.5 0.4 0.5
0.3 0.1
0.1 0.1 0.1
2.1
81
n = 81 81 80 78 75 72 69 61
0 2.0 1.5 1.0 0.5 2.5 3.5 3.0 4.0
Baseline Day 1 Day 7 Week 4 Month 3 Month 6 Month 9 Year 1 Year 2
Mean Number of Glaucoma Medications ± SD
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IOP (mmHg) 40
0 10 20 30
*
Baseline Day 1 Day 7 Week 4 Month 3 Month 6 Month 9 Year 1 Year 2
Visit
o +
o +
0.2 mg/mL MMC 0.4 mg/mL MMC
o + o
+
o + o
+ o
+ o
+ o
+
32 43 32 41 31 43 32 42 32 42 32 40 29 36 29 35 27 30
n =
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A
A
* 0.9
0.1
* 0.8
0.3
* 0.7
0.1 0.6
0.1
* 0.1
0.1
0.0 0.0 0.0
0.1 0.0
0.1 2.2
2.0
0.2 mg/mL MMC 0.4 mg/mL MMC
n = 32 43 32 43 32 43 32 42 32 42 32 40 32 37 30 36 27 31
0 2.0 1.5 1.0 0.5 2.5 3.5 3.0 4.0
Baseline Day 1 Day 7 Week 4 Month 3 Month 6 Month 9 Year 1 Year 2
Mean Number of Glaucoma Medications ± SD
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Ophthalmology®, Ophthalmology Retina™,
Ophthalmology Glaucoma™, and Ophthalmology Science™
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The journal adheres to the Uniform Requirements set by the International Committee of Medical Journal Editors (http://www.icmje.org/) for authorship. To qualify for authorship, authors must make substantial contributions to the intellectual content of the paper in each of the four following categories:
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By submitting this form, the corresponding author acknowledges that each author has read the statement on authorship responsibility and contribution to authorship. In the table below, please designate the contributions of each author. Any relevant contribution not described in the four columns can be added under “Other contributions.” Please note that the list of contributions will publish with the manuscript should it be accepted. Thank you.
TITLE OF ARTICLE: Safety and Effectiveness of the MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study
AUTHORS: Henny J.M. Beckers, Florent Aptel, Carroll A.B. Webers, Elisa Bluwol, José M. Martínez de la Casa, Julián García-Feijoó, Yves Lachkar, Carmen D. Méndez Hernández, Isabelle Riss, Hui Shao, Leonard Pinchuk, Raymund Angeles, Omar Sadruddin, Tarek M. Shaarawy
AUTHOR NAME RESEARCH DESIGN DATA ACQUISITION AND/OR RESEARCH
EXECUTION
DATA ANALYSIS AND/OR INTERPRETATION
MANUSCRIPT PREPARATION
Henny J.M. Beckers ☐ ☒ ☒ ☒
Florent Aptel ☐ ☒ ☒ ☒
Carroll A.B. Webers ☐ ☒ ☒ ☒
Elisa Bluwol ☐ ☒ ☒ ☒
José M. Martínez de la Casa
☐ ☒ ☒ ☒
Julián García-Feijoó ☐ ☒ ☒ ☒
Yves Lachkar ☐ ☒ ☒ ☒
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Carmen D. Méndez Hernández
☐ ☒ ☒ ☒
Isabelle Riss ☐ ☒ ☒ ☒
Hui Shao ☐ ☐ ☒ ☒
Leonard Pinchuk ☒ ☐ ☒ ☒
Raymund Angeles ☐ ☐ ☒ ☒
Omar Sadruddin ☐ ☐ ☒ ☒
Tarek M. Shaarawy ☐ ☒ ☒ ☒
OTHER CONTRIBUTIONS: