Early Complications and Results of Preserflo MicroShunt in the Management of Uncontrolled Open-Angle Glaucoma: A Case Series
Abstract
:1. Introduction
2. Materials and Methods
2.1. Preoperative and Postoperative Examination
2.2. Surgical Technique
2.3. Statistical Evaluation
3. Results
3.1. Best-Corrected Visual Acuity
3.2. Intraocular Pressure
3.3. Early Postoperative Complications
3.3.1. Hypotony and Choroidal Effusion
3.3.2. Hyphema
3.3.3. Keratitis
3.3.4. Bleb Fibrosis
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed consent statement
Data Availability Statement
Conflicts of Interest
References
- Quigley, H.A.; Broman, A.T. The Number of People with Glaucoma Worldwide in 2010 and 2020. Br. J. Ophthalmol. 2006, 90, 262–267. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Pillunat, L.E.; Erb, C.; Jünemann, A.G.M.; Kimmich, F. Micro-Invasive Glaucoma Surgery (MIGS): A Review of Surgical Procedures Using Stents. Clin. Ophthalmol. 2017, 11, 1583–1600. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Richter, G.M.; Coleman, A.L. Minimally Invasive Glaucoma Surgery: Current Status and Future Prospects. Clin. Ophthalmol. 2016, 10, 189–206. [Google Scholar] [CrossRef] [Green Version]
- European Glaucoma Society. Terminology and Guidelines for Glaucoma, 5th ed.; Editrice Dogma: Savona, Italy, 2020. [Google Scholar]
- Saheb, H.; Ahmed, I.I.K. Micro-Invasive Glaucoma Surgery: Current Perspectives and Future Directions. Curr. Opin. Ophthalmol. 2012, 23, 96–104. [Google Scholar] [CrossRef]
- Konopińska, J.; Lewczuk, K.; Jabłońska, J.; Mariak, Z.; Rękas, M. Microinvasive Glaucoma Surgery: A Review of Schlemm’s Canal-Based Procedures. Clin. Ophthalmol. 2021, 15, 1109–1118. [Google Scholar] [CrossRef]
- Jabłońska, J.; Lewczuk, K.; Konopińska, J.; Mariak, Z.; Rękas, M. Microinvasive glaucoma surgery: A review and classification of implant-dependent procedures and techniques. Acta Ophthalmol. 2022, 100, e327–e338. [Google Scholar] [CrossRef]
- Pillunat, K.R.; Herber, R.; Haase, M.A.; Jamke, M.; Jasper, C.S.; Pillunat, L.E. Preserflo Microshunt Versus Trabeculectomy: First Results on Efficacy and Safety. Acta Ophthalmol. 2021, 100, e779–e790. [Google Scholar] [CrossRef]
- Kerr, N.M.; Ahmed, I.I.K.; Pinchuk, L.; Sadruddin, O.; Palmerg, P.F. PRESERFLO MicroShunt. In Minimally Invasive Glaucoma Surgery; Springer: Singapore, 2020; pp. 91–103. Available online: https://link.springer.com/chapter/10.1007/978-981-15-5632-6_7#citeas (accessed on 1 April 2022).
- Batlle, J.F.; Fantes, F.; Riss, I.; Pinchuk, L.; Alburquerque, R.; Kato, Y.P.; Arrieta, E.; Peralta, A.C.; Palmberg, P.; Parrish, R.K.; et al. Three-Year Follow-Up of a Novel Aqueous Humor MicroShunt. J. Glaucoma 2016, 25, e58–e65. [Google Scholar] [CrossRef] [Green Version]
- Fox, A.R.; Risma, T.B.; Kam, J.P.; Bettis, D.I. MIGS: Minimally Invasive Glaucoma Surgery. Ophthalmol. Vis. Sci. Available online: Medicine.uiowa.edu/eye (accessed on 12 May 2022).
- Schlenker, M.B.; Durr, G.M.; Michaelov, E.; Ahmed, I.I.K. Intermediate Outcomes of a Novel Standalone Ab Externo SIBS Microshunt with Mitomycin C. Am. J. Ophthalmol. 2020, 215, 141–153. [Google Scholar] [CrossRef]
- Baker, N.D.; Barnebey, H.S.; Moster, M.R.; Stiles, M.C.; Vold, S.D.; Khatana, A.K.; Flowers, B.E.; Grover, D.S.; Strouthidis, N.G.; Panarelli, J.F.; et al. Ab-Externo MicroShunt Versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology 2021, 128, 1710–1721. [Google Scholar] [CrossRef] [PubMed]
- Al Habash, A.; Ali Aljasim, L.; Owaidhah, O.; Edward, D.P. A review of the efficacy of mitomycin C in glaucoma filtration surgery. Clin. Ophthalmol. 2015, 9, 1945–1951. [Google Scholar] [CrossRef] [Green Version]
- Chen, C.W. Enhanced intraocular pressure controlling effectiveness of trabeculectomy by local application of mitomycin C. Trans Asia Pac. Acad. Ophthalmol. 1988, 9, 172–177. [Google Scholar]
- Riss, I.; Batlee, J.; Pinchuk, L.; Kato, Y.P.; Weber, B.A.; Parel, J.M. 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, 855–860. [Google Scholar] [CrossRef] [PubMed]
- Coppens, G.; Maudgal, P. Corneal complications of intraoperative Mitomycin C in glaucoma surgery. Bull. Soc. Belge Ophtalmol. 2010, 19–23. [Google Scholar]
- Beckers, H.J.M.; Aptel, F.; Webers Carroll, A.B.; Martinez de-la-Casa, J.M.; Garcia-Feijoo, J.; Lachkar, Y.; Mendez-Hernandez, C.D.; Riss, I.; Shao, H.; Pinchuk, L.; et al. Safety and Effectiveness of the Preserflo® MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study. Ophthalmol. Glaucoma 2021, 5, 195–209. [Google Scholar] [CrossRef]
- Roa, T.M.; De La Rosa, S.; Netland, P. Five Pointers on Choroidal Effusion and suprachoroidal hemorrhage. Glaucoma Today. 2019. Available online: https://glaucomatoday.com/articles/2019-july-aug/five-pointers-on-choroidal-effusion-and-suprachoroidal-hemorrhage (accessed on 22 June 2022).
- Vastardis, I.; Fili, S.; Perdikakis, G.; Kontopoulou, K.; Balidis, M.; Gatzioufas, Z.; Kohlhaas, M. Preliminary results of Preserflo Microshunt versus Preserflo Microshunt and Ologen implantation. Eye Vis. 2021, 8, 33. [Google Scholar] [CrossRef]
- Gedde, S.J.; Feuer, W.J.; Shi, W.; Lim, K.; Barton, K.; Goyal, S.; Ahmed, I.I.K.; Brandt, J. Treatment outcomes in the Primary Tube Versus Trabeculectomy study after 1 year of follow-up. Ophthalmology 2018, 125, 650–663. [Google Scholar] [CrossRef]
- Wagner, F.M.; Schuster, A.K.; Munder, A.; Muehl, M.; Pfeiffer, N.; Hoffmann, E.M. Comparison of subconjunctival microinvasive glaucoma surgery and trabeculectomy. Acta Ophthalmol. 2021, 100, e1120–e1126. [Google Scholar] [CrossRef]
- Fea, A.M.; Laffi, G.L.; Martini, E.; Economou, M.A.; Caselgrandi, P.; Sacchi, M.; Au, L. Effectiveness of MicroShunt in Patients with Primary Open-Angle and Pseudoexfoliative Glaucoma: A Retrospective European Multicenter Study. Ophthalmol. Glaucoma 2022, 5, 210–218. [Google Scholar] [CrossRef]
- Scheres, L.M.J.; Kujovic-Aleksov, S.; Ramdas, W.D.; de Crom, R.M.P.C.; Roelofs, L.C.G.; Berendschot, T.T.J.M.; Webers, C.A.B.; Beckers, H.J.M. XEN Gel Stent compared to Preserflo MicroShunt implantation for primary open-angle glaucoma: Two years results. Acta Ophthalmol. 2021, 99, e433–e440. [Google Scholar] [CrossRef] [PubMed]
- Batlle, J.F.; Corona, A.; Albuquerque, R. Long term results of the Preserflo MicroShunt in patients with primary open-angle glaucoma from a single-center non-randomized study. J. Glaucoma 2021, 30, 281–286. [Google Scholar] [CrossRef] [PubMed]
- Gambini, G.; Carlà, M.M.; Giannuzzi, F.; Caporossi, T.; De Vico, U.; Savastano, A.; Baldascino, A.; Rizzo, C.; Kilian, R.; Caporossi, A.; et al. PreserFlo® MicroShunt: An Overview of This Minimally Invasive Device for Open-Angle Glaucoma. Vision 2022, 6, 12. [Google Scholar] [CrossRef] [PubMed]
- Bunod, R.; Robin, M.; Buffault, J.; Keilani, C.; Labbé, A.; Baudouin, C. PreserFlo MicroShunt® exposure: A case series. BMC Ophthalmol. 2021, 21, 273. [Google Scholar] [CrossRef] [PubMed]
Characteristic | Value |
---|---|
Sex (female:male), n (%) | 22 (73.3%):8 (26.7%) |
Age, mean ± SD | 68.53 ± 10.24 |
Combined treatment, n (%) | 4 (13.3%) |
Glaucoma, n (%) | |
POAG | 25 (83.3%) |
PXG | 5 (16.7%) |
Cataract, n (%) | 19 (63.3%) |
Medications before treatment, median (Q1; Q3) | 2.00 (1.25; 3.00) |
MMC, n (%) | |
0.2 | 22 (73.3%) |
0.5 | 8 (26.7%) |
Postoperative complications, n (%) | 14 (46.7%) |
Previous treatments, n (%) | |
Trabeculectomy | 3 (10.0%) |
SLT | 2 (6.7%) |
Ex-Press | 4 (13.3%) |
Cataract surgery 3 months after Preserflo implantation | 1 (3.3%) |
Measurement Time | VA Level Mean ± SD or Median (Q1; Q3) | VA Level before Treatment Mean ± SD or Median (Q1; Q3) | MD (95% CI) | W/t | p |
---|---|---|---|---|---|
Whole group | |||||
1 day after treatment | 0.25 (0.10; 0.48) | 0.20 (0.00; 0.040) | 0.05 (<0.01; 0.30) | 39.00 | 0.045 |
2 weeks after treatment | 0.20 (0.10; 0.38) | 0.00 (−0.10; 0.10) | 79.50 | 0.810 | |
1 month after treatment | 0.20 (0.10; 0.30) | 0.00 (−0.10; 0.05) | 112.00 | 0.504 | |
3 months after treatment | 0.10 (0.00; 0.20) | −0.10 (−0.25; <0.01) | 87.00 | 0.129 | |
6 months after treatment | 0.10 (0.00; 0.20) | −0.10 (−0.25; <0.01) | 105.50 | 0.054 | |
MMC = 0.2 | |||||
1 day after treatment | 0.35 (0.10; 0.65) | 0.25 (0.03; 0.40) | 0.10 (−0.05; 0.40) | 91.00 | 0.082 |
2 weeks after treatment | 0.20 (0.20; 0.38) | −0.05 (−0.15; 0.15) | 44.50 | 0.972 | |
1 month after treatment | 0.20 (0.10; 0.28) | −0.05 (−0.25; 0.05) | 44.00 | 0.613 | |
3 months after treatment | 0.15 (0.00; 0.20) | −0.10 (−0.35; 0.10) | 21.00 | 0.303 | |
6 months after treatment | 0.10 (0.00; 0.20) | −0.15 (−0.35; 0.10) | 15.00 | 0.118 | |
MMC = 0.5 | |||||
1 day after treatment | 0.21 ± 0.17 | 0.15 (0.00; 0.25) 0.18 ± 0.19 | 0.03 (−0.05; 0.13) | 1.00 | 0.351 |
2 weeks after treatment | 0.20 ± 0.15 | 0.02 (−0.06; 0.11) | 0.68 | 0.517 | |
1 month after treatment | 0.16 ± 0.15 | −0.02 (−0.08; 0.06) | −0.42 | 0.685 | |
3 months after treatment | 0.14 ± 0.15 | −0.04 (−0.11; 0.04) | −1.16 | 0.285 | |
6 months after treatment | 0.00 (0.00; 0.33) | −0.15 (−0.15; 0.10) | 4.00 | 0.410 |
Measurement Time | IOP Level Median (Q1; Q3) | IOP Level before Treatment Median (Q1; Q3) | MD (95% CI) | W | p |
---|---|---|---|---|---|
Whole group | |||||
1 day after treatment | 8.50 (6.00; 12.00) | 22.50 (21.00; 26.75) | −14.00 (−17.00; −10.50) | 1.50 | <0.001 |
2 weeks after treatment | 10.50 (8.25; 13.75) | −12.00 (−16.50; −10.00) | 2.00 | <0.001 | |
1 month after treatment | 13.00 (10.25; 18.75) | −9.50 (−13.00; −7.50) | 14.00 | <0.001 | |
3 months after treatment | 13.50 (12.00; 17.75) | −9.00 (−12.50; −6.50) | 11.00 | <0.001 | |
6 months after treatment | 14.00 (13.00; 19.00) | −8.50 (−11.50; −6.00) | 16.50 | <0.001 | |
MMC = 0.2 | |||||
1 day after treatment | 9.00 (6.00; 12.75) | 22.50 (20.00; 26.75) | −13.50 (−18.00; −9.00) | 1.50 | <0.001 |
2 weeks after treatment | 10.00 (8.25; 14.00) | −12.50 (−18.50; −9.00) | 2.00 | <0.001 | |
1 month after treatment | 15.50 (10.00; 21.25) | −7.00 (−13.50; −5.00) | 14.00 | 0.001 | |
3 months after treatment | 15.50 (12.25; 19.75) | −7.00 (−13.00; −5.00) | 11.00 | <0.001 | |
6 months after treatment | 14.50 (13.25; 19.00) | −8.00 (−12.50; −4.50) | 16.00 | <0.001 | |
MMC = 0.5 | |||||
1 day after treatment | 8.00 (6.00; 10.50) | 22.50 (21.75; 25.00) | −14.50 (−19.00; −11.00) | <0.01 | 0.014 |
2 weeks after treatment | 12.00 (9.50; 12.00) | −10.50 (−18.00; −9.50) | <0.01 | 0.014 | |
1 month after treatment | 12.50 (11.75; 13.00) | −10.00 (−15.00; −8.50) | <0.01 | 0.014 | |
3 months after treatment | 12.00 (11.75; 13.00) | −10.50 (−14.00; −9.00) | <0.01 | 0.014 | |
6 months after treatment | 13.00 (12.50; 16.00) | −9.50 (−13.00; −7.00) | <0.01 | 0.022 |
Characteristic | Range |
---|---|
Age | 48.00; 88.00 |
VA before treatment | 0.00; 1.30 |
VA 1 day after treatment | 0.00; 1.50 |
VA 2 weeks after treatment | 0.00; 1.30 |
VA 1 month after treatment | 0.00; 1.30 |
VA 3 months after treatment | 0.00; 1.30 |
VA 6 months after treatment | 0.00; 1.30 |
IOP before treatment | 15.00; 47.00 |
IOP 1 day after treatment | 3.00; 26.00 |
IOP 2 weeks after treatment | 3.00; 24.00 |
IOP 1 month after treatment | 5.00; 28.00 |
IOP 3 months after treatment | 7.00; 26.00 |
IOP 6 months after treatment | 8.00; 28.00 |
Postoperative Complications/Interventions | n (%) |
---|---|
Hypotony | 5 (16.7%) |
Choroidal effusion | 1 (3.3%) |
Keratitis | 2 (6.7%) |
Flare in anterior chamber | 1 (3.3%) |
Increased intraocular pressure | 4 (13.3%) |
Needling | 2 (6.7%) |
Hyphema | 1 (3.3%) |
Preserflo Revision | 1 (3.3%) |
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Saeed, E.; Zalewska, R.; Konopińska, J. Early Complications and Results of Preserflo MicroShunt in the Management of Uncontrolled Open-Angle Glaucoma: A Case Series. Int. J. Environ. Res. Public Health 2022, 19, 8679. https://doi.org/10.3390/ijerph19148679
Saeed E, Zalewska R, Konopińska J. Early Complications and Results of Preserflo MicroShunt in the Management of Uncontrolled Open-Angle Glaucoma: A Case Series. International Journal of Environmental Research and Public Health. 2022; 19(14):8679. https://doi.org/10.3390/ijerph19148679
Chicago/Turabian StyleSaeed, Emil, Renata Zalewska, and Joanna Konopińska. 2022. "Early Complications and Results of Preserflo MicroShunt in the Management of Uncontrolled Open-Angle Glaucoma: A Case Series" International Journal of Environmental Research and Public Health 19, no. 14: 8679. https://doi.org/10.3390/ijerph19148679