Safety and efficacy of a modified suprachoroidal silicone tube shunt implant in primary open angle and pseudo-exfoliative glaucoma

Abstract

Purpose

To assess the safety and efficacy of a modified suprachoroidal silicone tube (SST) shunt in patients with primary open-angle glaucoma (POAG) and pseudo-exfoliative glaucoma (PXG) in this experimental study.

Methods

In this single-center, retrospective longitudinal data analysis 66 eyes of 59 patients having POAG and PXG were included and treated with modified SST shunt in combination with cataract or as a stand-alone procedure. Pre- and postoperative intraocular pressure (IOP), best corrected visual acuity (BCVA), C/D ratio and ocular adverse events (AEs) were assessed in all participants.

Results

The average follow-up period was 18.56 ± 7.93 months. Mean baseline IOP reduced from 27.02 ± 5.43 mmHg to 13.23 ± 3.70 mmHg (p < 0.001). Mean number of ocular hypotensive medications reduced from 3.17 ± 0.89 to 1.83 ± 1.44 (p < 0.001). BCVA remained stable in 49 eyes (74.2%) throughout the follow-up period. Mean baseline BCVA of 0.73 ± 0.27 slightly declined to 0.68 ± 0.30 at the final follow-up (p < 0.001). Three adverse events of special interest (AESI) were observed hypotonic maculopathy, anterior chamber inflammation with pupillary membranes, and macular edema. None of these events was related to the SST shunt. Other complications such as intra and early postoperative hyphema in 3 and tube-iris contact causing slight corectopia in 2 cases were noted.

Conclusions

The surgical technique and device studied in this work demonstrated a good safety profile and signal of efficacy. This device may serve as a bridge between minimally invasive glaucoma surgeries (MIGS) and conventional filtering or episcleral tube shunt surgeries. A larger scale prospective trial is planned.

Keywords

Exfoliative glaucoma primary open angle glaucoma silicone tube suprachoroidal shunt BAGS

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References

Allison

Patel

Alabi

. Epidemiology of glaucoma: The past, present, and predictions for the future. Cureus 12. Epub ahead of print 25 November 2020. DOI: https://doi.org/10.7759/CUREUS.11686.

Garg

Gazzard

. Treatment choices for newly diagnosed primary open angle and ocular hypertension patients. Eye 2019; 34: 60–71.

Gazzard

Konstantakopoulou

Garway-Heath

, et al. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Lancet 2019; 393: 1505–1516.

European Glaucoma Society. Terminology and guidelines for glaucoma. 5th edition. Savona: PubliComm, 2021.

Shah

. Micro-invasive glaucoma surgery – an interventional glaucoma revolution. Eye and Vision 2019; 6: 1–5.

Sng

CCA

Barton

. Minimally invasive glaucoma surgery. Springer Nature, 2021. Epub ahead of print 1 January 2021. DOI: https://doi.org/10.1007/978-981-15-5632-6.

Ansari

. An update on implants for minimally invasive glaucoma surgery (MIGS). Ophthalmol Ther 2017; 6: 233–241.

Heine

. Die cyclodialyse, eine neue glaukomoperation. Dtsch Med Wochenschr 1905; 31: 824–826.

Querenghi

. Faits et raisons qui expliquent Taction de la scle-roiridectomie et des autres operations succedanees (scleroto-mie et incision de l’angle iridocorneen) dans le traitment du glaucoma. Ann Ocul 1900; 123: 441.

10.

Gigon

Shaarawy

. The suprachoroidal route in glaucoma surgery. J Curr Glaucoma Pract 2016; 10: 20.

11.

Melamed

Simon Guy

Goldenfeld

, et al. Efficacy and safety of gold micro shunt implantation to the supraciliary space in patients with glaucoma. Arch Ophthalmol 2009; 127: 264.

12.

Loscos-Arenas

Parera-Arranz

Romera-Romera

, et al. Deep sclerectomy with a new nonabsorbable uveoscleral implant (Esnoper-clip). J Glaucoma 2015; 24: 421–425.

13.

World Glaucoma Association.

Guidelines on design and reporting of glaucoma surgical trials. Amsterdam: Kugler publications, 2009.

14.

Jordan

Engels

Dinslage

, et al. A novel approach to suprachoroidal drainage for the surgical treatment of intractable glaucoma. J Glaucoma 2006; 15: 200–205.

15.

Unal

Kocak Altintas

Koklu

, et al. Early results of suprachoroidal drainage tube implantation for the surgical treatment of glaucoma. J Glaucoma 2011; 20: 307–314.

16.

Poley

Lindstrom

Samuelson

, et al. 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.

17.

Shrivastava

Singh

. The effect of cataract extraction on intraocular pressure. Curr Opin Ophthalmol 2010; 21: 118–122.

18.

Alm

Nilsson

SFE

. Uveoscleral outflow – A review. Exp Eye Res 2009; 88: 760–768.

19.

Yablonski

. Some thoughts on the pressure dependence of uveoscleral flow. J Glaucoma 2003; 12: 90–92.

20.

Krohn

Bertelsen

. Light microscopy of uveoscleral drainage routes after gelatine injections into the suprachoroidal space. Acta Ophthalmol Scand 1998; 76: 521–527.

21.

Vold

Ahmed

IIK

Craven

, et al. Two-Year COMPASS trial results: supraciliary microstenting with phacoemulsification in patients with open-angle glaucoma and cataracts. Ophthalmology 2016; 123: 2103–2112.

22.

Dick

Mackert

Ahmed

IIK

, et al. Two-Year performance and safety results of the MINIject supraciliary implant in patients with primary open-angle glaucoma: meta-analysis of the STAR-I, II, III trials. Am J Ophthalmol 2024; 260: 172–181.

23.

Yablonski

. Trabeculectomy with internal tube shunt: a novel glaucoma surgery. J Glaucoma 2005; 14: 91–97.

24.

Palamar

Ates

Oztas

, et al. Suprachoroidal implant surgery in intractable glaucoma. Jpn J Ophthalmol 2011; 55: 351–355.

25.

Simsek

Bilgeç

. Ahmed glaucoma valve implantation versus suprachoroidal silicone tube implantation following the injection of bevacizumab into the anterior chamber in patients with neovascular glaucoma. Graefe’s Archive Clin Experiment Ophthalmol 2019; 257: 799–804.

26.

Laroche

Nkrumah

. Combination microinvasive glaucoma surgery: 23-gauge cystotome goniotomy and intra-scleral ciliary sulcus suprachoroidal microtube surgery in refractory and severe glaucoma: a case series. Indian J Ophthalmol 2020; 68: 2557–2561.

27.

Laroche

Nkrumah

. Real-world efficacy of the intrascleral ciliary sulcus suprachoroidal microtube technique in Black and Afro-Latinx patients with glaucoma: a 1-year retrospective study. Ther Adv Ophthalmol 15. Epub ahead of print 24 January 2023. DOI: https://doi.org/10.1177/25158414221147445.

28.

Emi

Pederson

Toris

. Hydrostatic pressure of the suprachoroidal space. Invest Ophthalmol Vis Sci 1989; 30: 233–238.

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