Preliminary results of Preserflo Microshunt versus Preserflo Microshunt and Ologen implantation
Tóm tắt
To report preliminary 6-month results on the use of the Preserflo Microshunt implant with and without Ologen in 50 pseudophakic eyes with moderate to advanced primary open-angle glaucoma (POAG). Fifty pseudophakic eyes underwent ab externo Preserflo Microshunt implantation. Data was gathered retrospectively and two groups were then created, group A with application of MMC 0.2 mg/ml and group B with MMC 0.2 mg/ml and Ologen collagen matrix (OCM) implantation. Absolute success was regarded as the percentage of eyes achieving: a) 5 ≤ intraocular pressure (IOP) ≤ 13 mmHg, b) 5 ≤ IOP ≤ 16 mmHg, and c) 5 ≤ IOP ≤ 21 mmHg without additional medication or surgery and qualified success was regarded as the percentage of eyes achieving a) IOP ≤ 13 mmHg, b) IOP ≤ 16 mmHg, and c) IOP ≤ 21 mmHg with or without medication. Evaluation was performed using a log-rank Kaplan-Meier test. A scatterplot analysis presented the treatment effect data of all eyes with a minimum of 20% IOP reduction per case. Failure was defined as requiring additional surgery, IOP greater than 21 mmHg with or without medication and failure to reach 20% IOP reduction. Mean postoperative IOP was significantly lower in both groups. IOP decreased by 49.06% in group A and by 53.01% in group B at 6 months (P < 0.88), respectively. Medication use was lower in both groups (Wilcoxon test, P < 0.001). The absolute and qualified success rates were not statistically significant between the groups (all P > 0.05). Cumulative IOP results per case were not statistically different in group A compared with group B. One revision surgery in group A (4% failure rate) and three in group B (12% failure rate) were performed. Both groups showed equal results in terms of cumulative and mean IOP reduction, medication reduction as well as in absolute and qualified success rates. No significant difference was found in any parameters tested between Preserflo Microshunt with MMC 0.2 mg/ml and with or without OCM implantation at 6 months. Long-term follow-up is required to further evaluate this data.
Tài liệu tham khảo
Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 1996;80(5):389–93.
Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121(11):2081–90.
Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M, et al. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120(10):1268–79.
Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, et al. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120(6):701–13; discussion 829-30.
Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, et al. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001;108(11):1943–53.
Sawchyn AK, Slabaugh MA. Innovations and adaptations in trabeculectomy. Curr Opin Ophthalmol. 2016a;27(2):158–63.
Lavia C, Dallorto L, Maule M, Ceccarelli M, Fea AM. Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: a systematic review and meta-analysis. PLoS One. 2017;12(8):e0183142.
King AJ, Shah A, Nikita E, Hu K, Mulvaney CA, Stead R, et al. Subconjunctival draining minimally-invasive glaucoma devices for medically uncontrolled glaucoma. Cochrane Database Syst Rev. 2018;12(12):CD012742.
Cutolo CA, Iester M, Bagnis A, Bonzano C, Negri L, Olivari S, et al. Early postoperative intraocular pressure is associated with better pressure control after XEN implantation. J Glaucoma. 2020;29(6):456–60.
Mansouri K, Guidotti J, Rao HL, Ouabas a, D'Alessandro E, Roy S, et al. prospective evaluation of standalone XEN gel implant and combined phacoemulsification-XEN gel implant surgery: 1-year results. J Glaucoma. 2018;27(2):140–7.
Pinchuk L, Riss I, Batlle JF, Kato YP, Martin JB, Arrieta E, et al. The use of poly (styrene-block-isobutylene-block-styrene) as a microshunt to treat glaucoma. Regen Biomater. 2016;3(2):137–42.
Pinchuk L, Riss I, Batlle JF, Kato YP, Martin JB, Arrieta E, et al. The development of a micro-shunt made from poly (styrene-block-isobutylene-block-styrene) to treat glaucoma. J Biomed Mater Res B Appl Biomater. 2017;105(1):211–21.
Pinchuk L, Wilson GJ, Barry JJ, Schoephoerster RT, Parel JM, Kennedy JP. Medical applications of poly (styrene-block-isobutylene-block-styrene) (“SIBS”). Biomaterials. 2008;29(4):448–60.
Cillino S, Di Pace F, Cillino G, Casuccio A. Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial. Eye (Lond). 2011;25(12):1598–606.
Fili S, Seddig S, Kohlhaas M. Long-term results after trabeculectomy combined with mitomycin C and Ologen implant. Klin Monatsbl Augenheilkd. 2019;236(9):1107–14.
Papaconstantinou D, Georgalas I, Karmiris E, Diagourtas A, Koutsandrea C, Ladas I, et al. Trabeculectomy with OloGen versus trabeculectomy for the treatment of glaucoma: a pilot study. Acta Ophthalmol. 2010;88(1):80–5.
Rho S, Sung Y, Ma KT, Rho SH, Kim CY. Bleb analysis and short-term results of biodegradable collagen matrix-augmented Ahmed glaucoma valve implantation: 6-month follow-up. Invest Ophthalmol Vis Sci. 2015;56(10):5896–903.
Chen X, Yuan F. Ologen implantation versus conjunctival autograft transplantation for treatment of pterygium. J Ophthalmol. 2018;2018:1617520.
Picht G, Grehn F. Classification of filtering blebs in trabeculectomy: biomicroscopy and functionality. Curr Opin Ophthalmol. 1998;9(2):2–8.
Picht G, Grehn F. Development of the filtering bleb after trabeculectomy. Classification, histopathology, wound healing process. Ophthalmologe. 1998;95(5):W380–7.
Klink J, Schmitz B, Lieb WE, Klink T, Grein HJ, Sold-Darseff J, et al. Filtering bleb function after clear cornea phacoemulsification: a prospective study. Br J Ophthalmol. 2005;89(5):597–601.
Hodapp E, Parrish RK II, Anderson DR. Clinical decisions in glaucoma. St Louis: The CV Mosby Co; 1993. p. 52–61.
Sawchyn AK, Slabaugh MA. Innovations and adaptations in trabeculectomy. Curr Opin Ophthalmol. 2016;27(2):158–63.
Zahid S, Musch DC, Niziol LM. Lichter PR; Collaborative Initial Glaucoma Treatment Study Group. Risk of endophthalmitis and other long-term complications of trabeculectomy in the Collaborative Initial Glaucoma Treatment Study (CIGTS). Am J Ophthalmol. 2013;155(4):674–80.
Lenzhofer M, Kersten-Gomez I, Sheybani A, Gulamhusein H, Strohmaier C, Hohensinn M, et al. Four-year results of a minimally invasive transscleral glaucoma gel stent implantation in a prospective multi-centre study. Clin Exp Ophthalmol. 2019;47(5):581–7.
Gillmann K, Bravetti GE, Mermoud A, Rao HL, Mansouri K. XEN Gel Stent in pseudoexfoliative glaucoma: 2-year results of a prospective evaluation. J Glaucoma. 2019;28(8):676–84.
Mansouri K, Gillmann K, Rao HL, Guidotti J, Mermoud A. Prospective evaluation of XEN Gel implant in eyes with pseudoexfoliative glaucoma. J Glaucoma. 2018;27(10):869–73.
Buffault J, Baudouin C, Labbé A. XEN® Gel Stent for management of chronic open angle glaucoma: a review of the literature. J Fr Ophtalmol. 2019;42(4):391–403.
Riss I, Batlle J, Pinchuk L, Kato YP, Weber BA, Parel JM. One-year results on the safety and efficacy of the InnFocus MicroShunt™ depending on placement and concentration of mitomycin C. J Fr Ophtalmol. 2015;38(9):855–60.
Sadruddin O, Pinchuk L, Angeles R, Palmberg P. Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review. Eye Vis (Lond). 2019;6:36.
Batlle JF, Fantes F, Riss I, Pinchuk L, Alburquerque R, Kato YP, et al. Three-year follow-up of a novel aqueous humor microshunt. J Glaucoma. 2016;25(2):e58–65.
Schlenker MB, Durr GM, Michaelov E, Ahmed IIK. Intermediate outcomes of a novel standalone ab externo SIBS microshunt with mitomycin C. Am J Ophthalmol. 2020;215:141–53.
Durr GM, Schlenker MB, Samet S, Ahmed IIK. One-year outcomes of stand-alone ab externo SIBS microshunt implantation in refractory glaucoma. Br J Ophthalmol. 2020 Oct;23 bjophthalmol-2020-317299.