Combining Baerveldt Implant with Trabectome Negates Tube Fenestration: A Coarsened-matched Comparison

Abstract

Purpose: To assess the efficacy and survival rate of the Trabectome-mediated ab interno trabeculectomy combined with non-fenestrated Baerveldt glaucoma implant compared with the Baerveldt glaucoma implant alone.


Method: In this retrospective comparative case series, 175 eyes undergoing primary glaucoma surgery (Baerveldt–Trabectome [BT] group: 60 eyes and Baerveldt [B] group: 115 eyes) were included. Participants were identified using the procedural terminology codes. Groups were then matched by Coarsened Exact Matching that resulted in the inclusion of 51 eyes in each group. The primary outcome measure was surgical success defined as 5 mmHg < intraocular pressure (IOP) ≤ 21 mmHg, and IOP reduction ≥ 20% from baseline, and no need to reoperation for glaucoma. Secondary outcome measures were IOP, number of glaucoma medications, and best-corrected visual acuity (BCVA).


Results: The cumulative probability of success at one year was 61% in the BT group and 50% in the B group. IOP decreased from 23.5 ± 2.4 mmHg at baseline to 14.1 ± 2.7 mmHg at the final follow-up in the BT group (P = 0.001). The corresponding values for the B group were 23.2 ± 2.0 mmHg and 13.9 ± 1.6 mmHg, respectively (P = 0.001). There was no significant difference between the groups in terms of IOP at the final follow-up (P = 0.56). The number of medications at baseline was 2.3 ± 0.3 in both groups. However, the BT group needed fewer drops at all postoperative time intervals and used 1.1 ± 0.3 versus 2.0 ± 0.4 eye drops (group B) at the final follow-up visit (P = 0.004). Eyes in B with phacoemulsification had a significantly higher IOP on day 1 compared to B (23.2 ± 14.3 versus 17.9 ± 11.4, P = 0.041). During the one-year follow-up, 7 (13.7%) patients in BT group and 18 (35.2%) in B group experienced hypotony (P = 0.04). No dangerous hypotony or hypertension occurred in BT group. The mean BCVA at baseline was 0.64 ± 0.85 logMAR and changed to 0.55 ± 0.75 logMAR in BT and B groups, respectively (P = 0.663). The corresponding numbers for the final follow-up visit was 0.72 ± 1.07 and 0.63 ± 0.97 logMAR, respectively (P = 0.668).


Conclusion: We observed similar rates of success and IOP reduction using BT and B techniques. BT group needed fewer glaucoma medications. Tube fenestration was unnecessary in BT group resulting in less postoperative ocular hypotony and hypertension. The results of our study indicate that additional trabectome procedure makes Baerveldt glaucoma implant safer, easier to handle, and more predictable in the most vulnerable patients with advanced glaucoma.

Keywords:

Ab Interno Trabeculectomy, Baerveldt Glaucoma Implantation, Glaucoma Drainage Devices, Trabectome Surgery, Tube Ligation

References
1. Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL, et al. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol 2012;153:789–803.e2.

2. Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol 2012;153:804–814.e1.

3. Esfandiari H, Pakravan M, Loewen NA, Yaseri M. Predictive value of early postoperative IOP and bleb morphology in Mitomycin-C augmented trabeculectomy. F1000Res 2017;6:1898. Retrieved from: https://doi.org/10.12688/f1000research.12904.1

4. Pakravan M, Esfandiari H, Yazdani S, Douzandeh A, Amouhashemi N, Yaseri M, et al. Mitomycin C-augmented trabeculectomy: subtenon injection versus soaked sponges: a randomised clinical trial. Br J Ophthalmol 2017;101:1275–1280.

5. Tseng VL, Coleman AL, Chang MY, Caprioli J. Aqueous shunts for glaucoma. Cochrane Database Syst Rev 2017;7:CD004918.

6. Patel S, Pasquale LR. Glaucoma drainage devices: a review of the past, present, and future. Semin Ophthalmol 2010;25:265–270.

7. Minckler DS, Francis BA, Hodapp EA, Jampel HD, Lin SC, Samples JR, et al. Aqueous shunts in glaucoma: a report by the American Academy of Ophthalmology. Ophthalmology 2008;115:1089–1098.

8. Abbas A, Agrawal P, King AJ. Exploring literaturebased definitions of hypotony following glaucoma filtration surgery and the impact on clinical outcomes. Acta Ophthalmol 2018;96:e285–e289.

9. Kansal S, Moster MR, Kim D, Schmidt CM Jr, Wilson RP, Katz LJ. Effectiveness of nonocclusive ligature and fenestration used in Baerveldt aqueous shunts for early postoperative intraocular pressure control. J Glaucoma 2002;11:65–70.

10. Ortiz Arismendi GE, Peña Valderrama CDP, Albis-Donado O. Results of a new technique for implantation of nonrestrictive glaucoma devices. J Curr Glaucoma Pract 2013;7:130–135.

11. Trible JR, Brown DB. Occlusive ligature and standardized fenestration of a Baerveldt tube with and without antimetabolites for early postoperative intraocular pressure control. Ophthalmology 1998;105:2243–2250.

12. Iacus SM, King G, Porro G. CEM: software for coarsened exact matching. J Stat Softw 2009;30:1–27.

13. Iacus SM, King G, Porro G. Causal inference without balance checking: coarsened exact matching. Polit Anal 2012;20:1–24. 14. Rubin DB, Thomas N. Combining propensity score matching with additional adjustments for prognostic covariates. J Am Stat Assoc 2000;95:573–585.

15. Seeger JD, Williams PL, Walker AM. An application of propensity score matching using claims data. Pharmacoepidemiol Drug Saf 2005;14:465–476.

16. Parikh HA, Bussel II, Schuman JS, Brown EN, Loewen NA. Coarsened exact matching of phaco-trabectome to trabectome in phakic patients: lack of additional pressure reduction from phacoemulsification. PLoS ONE 2016;11:e0149384.

17. Neiweem AE, Bussel II, Schuman JS, Brown EN, Loewen NA. Glaucoma surgery calculator: limited additive effect of phacoemulsification on intraocular pressure in ab interno trabeculectomy. PLoS ONE 2016;11:e0153585.

18. Iacus SM, King G, Porro G. causal inference without balance checking: coarsened exact matching. Polit Anal 2012;20:1–24.

19. Kostanyan T, Shazly T, Kaplowitz KB, Wang SZ, Kola S, Brown EN, et al. Longer-term Baerveldt to Trabectome glaucoma surgery comparison using propensity score matching. Graefes Arch Clin Exp Ophthalmol 2017;255:2423–2428. Retrieved from: https://doi.org/10.1007/s00417-017-3804-9.

20. Christakis PG, Zhang D, Budenz DL, Barton K, Tsai JC, Ahmed IIK, et al. Five-year pooled data analysis of the Ahmed Baerveldt comparison study and the Ahmed Versus Baerveldt Study. Am J Ophthalmol 2017;176:118– 126.

21. Christakis PG, Kalenak JW, Tsai JC, Zurakowski D, Kammer JA, Harasymowycz PJ, et al. The Ahmed Versus Baerveldt Study: five-year treatment outcomes. Ophthalmology 2016;123:2093–2102.

22. Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology 2011;118:443–452.

23. Aref AA, Gedde SJ, Budenz DL. Glaucoma drainage implant surgery. Dev Ophthalmol 2012;50:37–47.

24. Molteno AC, Van Biljon G, Ancker E. Two-stage insertion of glaucoma drainage implants. Trans Ophthalmol Soc N Z 1979;31:17–26.

25. Molteno AC, Polkinghorne PJ, Bowbyes JA. The vicryl tie technique for inserting a draining implant in the treatment of secondary glaucoma. Aust N Z J Ophthalmol 1986;14:343–354.

26. Egbert PR, Lieberman MF. Internal suture occlusion of the Molteno glaucoma implant for the prevention of postoperative hypotony. Ophthalmic Surg 1989;20:53– 56.

27. Sherwood MB, Smith MF. Prevention of early hypotony associated with Molteno implants by a new occluding stent technique. Ophthalmology 1993;100:85–90.

28. Campbell RJ, Buys YM, McIlraith IP, Trope GE.) Internal glaucoma drainage device tube fenestration for uncontrolled postoperative intraocular pressure. J Glaucoma 2008;17:494–496.

29. Kaplowitz K, Bussel II, Honkanen R, Schuman JS, Loewen NA. Review and meta-analysis of abinterno trabeculectomy outcomes. Br J Ophthalmol 2016;100:594–600.

30. Ngai P, Kim G, Chak G, Lin K, Maeda M, Mosaed S. Outcome of primary trabeculotomy ab interno (Trabectome) surgery in patients with steroid-induced glaucoma. Medicine 2016;95:e5383.

31. Ting JLM, Damji KF, Stiles MC, Trabectome Study Group. Ab interno trabeculectomy: outcomes in exfoliation versus primary open-angle glaucoma. J Cataract Refract Surg 2012;38:315–323.

32. Bussel II, Kaplowitz K, Schuman JS, Loewen NA, Trabectome Study Group. Outcomes of ab interno trabeculectomy with the Trabectome by degree of angle opening. Br J Ophthalmol 2015;99:914–919.

33. Minckler DS, Baerveldt G, Alfaro MR, Francis BA. Clinical results with the Trabectome for treatment of open-angle glaucoma. Ophthalmology 2005;112:962–967.

34. Loewen RT, Roy P, Parikh HA, Dang Y, Schuman JS, Loewen NA. Impact of a Glaucoma Severity Index on results of trabectome surgery: larger pressure reduction in more severe glaucoma. PLoS ONE 2016;11:e0151926.

35. Bussel II, Kaplowitz K, Schuman JS, Loewen NA, Trabectome Study Group. Outcomes of ab interno trabeculectomy with the trabectome after failed trabeculectomy. Br J Ophthalmol 2015;99:258–262.

36. Mosaed S, Chak G, Haider A, Lin KY, Minckler DS. Results of trabectome surgery following failed glaucoma tube shunt implantation: cohort study. Medicine 2015;94:e1045.

37. Pisella PJ, Pouliquen P, Baudouin C. Prevalence of ocular symptoms and signs with preserved and preservative free glaucoma medication. Br J Ophthalmol 2002;86:418–423.

38. Tsai JC, McClure CA, Ramos SE, Schlundt DG, Pichert JW. Compliance barriers in glaucoma: a systematic classification. J Glaucoma 2003;12:393–398.

39. Lavin MJ, Wormald RP, Migdal CS, Hitchings RA. The influence of prior therapy on the success of trabeculectomy. Arch Ophthalmol 1990;108:1543–1548.

40. Broadway D, Grierson I, Hitchings R. Adverse effects of topical antiglaucomatous medications on the conjunctiva. Br J Ophthalmol 1993;77:590–596.

41. Loon SC, Jin J, Jin Goh M. The relationship between quality of life and adherence to medication in glaucoma patients in Singapore. J Glaucoma 2015;24:e36–42.

42. Poley BJ, Lindstrom RL, Samuelson TW, Schulze R Jr () Intraocular pressure reduction after phacoemulsification with intraocular lens implantation in glaucomatous and nonglaucomatous eyes: evaluation of a causal relationship between the natural lens and open-angle glaucoma. J Cataract Refract Surg 2009; 35:1946–1955.

43. Slabaugh MA, Bojikian KD, Moore DB, Chen PP. Risk factors for acute postoperative intraocular pressure elevation after phacoemulsification in glaucoma patients. J Cataract Refract Surg 2014;40:538–544.

44. Weiner Y, Severson ML, Weiner A. Intraocular pressure 3 to 4 hours and 20 hours after cataract surgery with and without ab interno trabeculectomy. J Cataract Refract Surg 2015;41:2081–2091.

45. Dang Y, Waxman S, Wang C, Parikh HA, Bussel II, Loewen RT, et al. Rapid learning curve assessment in an ex vivo training system for microincisional glaucoma surgery. Sci Rep 2017;7:1605.