Abstract
Purpose
To compare results of two ophthalmic viscosurgical devices (OVDs)—Viscoat (a dispersive OVD, Alcon) and FR-Pro (a viscous-cohesive OVD, Rayner), in phacoemulsification surgery.
Methods
A prospective randomized controlled study. Patients undergoing phacoemulsification were randomly assigned to receive one of the two OVDs. Exclusion criteria were age under 40, preoperative endothelial cell count (ECC) below 1,500 cells/mm2 and an eventful surgery.
The primary outcome was change in ECC from baseline to postoperative month one and month three. Secondary outcomes were the difference between ECC at postoperative month one and month three, changes in IOP and occurrence of an IOP spike ≥ 30 mmHg after surgery.
Results
The study included 84 eyes—43 in the Viscoat group and 41 in the FR-Pro group. Mean cell density loss at month one and month three was 17.0 and 19.2%, respectively, for the Viscoat group and 18.4 and 18.8%, respectively, for the FR-Pro group, with no statistically significant difference between the groups (p = 0.772 and p = 0.671, respectively). The mean ECC difference between the month one and month three visits was 50.5 cells/mm2 and was not statistically significant (p = 0.285). One eye in each group had an IOP spike ≥ 30 mmHg, both normalized by postoperative week one.
Conclusions
Viscoat and FR-Pro have comparable results following phacoemulsification surgery, suggesting that while FR-Pro is not a dispersive OVD, its endothelial cell protection may be comparable to one, perhaps due to the addition of sorbitol. Furthermore, a one-month follow-up of ECC seems sufficient in such trials.
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References
Vajpayee RB, Verma K, Sinha R, Titiyal JS, Pandey RM, Sharma N (2005) Comparative evaluation of efficacy and safety of ophthalmic viscosurgical devices in phacoemulsification [ISRCTN34957881]. BMC Ophthalmol 5:17. https://doi.org/10.1186/1471-2415-5-17
Miyata K, Nagamoto T, Maruoka S, Tanabe T, Nakahara M, Amano S (2002) Efficacy and safety of the soft-shell technique in cases with a hard lens nucleus. J Cataract Refract Surg 28(9):1546–1550. https://doi.org/10.1016/s0886-3350(02)01323-8
Storr-Paulsen A, Nørregaard JC, Farik G, Tårnhøj J (2007) The influence of viscoelastic substances on the corneal endothelial cell population during cataract surgery: a prospective study of cohesive and dispersive viscoelastics. Acta Ophthalmol Scand 85(2):183–187. https://doi.org/10.1111/j.1600-0420.2006.00784.x
Van den Bruel A, Gailly J, Devriese S, Welton NJ, Shortt AJ, Vrijens F (2011) The protective effect of ophthalmic viscoelastic devices on endothelial cell loss during cataract surgery: a meta-analysis using mixed treatment comparisons. Br J Ophthalmol 95(1):5–10. https://doi.org/10.1136/bjo.2009.158360
Zetterström C, Laurell CG (1995) Comparison of endothelial cell loss and phacoemulsification energy during endocapsular phacoemulsification surgery. J Cataract Refract Surg 21(1):55–58. https://doi.org/10.1016/s0886-3350(13)80480-4
Moschos MM, Chatziralli IP, Sergentanis TN (2011) Viscoat versus Visthesia during phacoemulsification cataract surgery: corneal and foveal changes. BMC Ophthalmol 11:9. https://doi.org/10.1186/1471-2415-11-9
Maár N, Graebe A, Schild G, Stur M, Amon M (2001) Influence of viscoelastic substances used in cataract surgery on corneal metabolism and endothelial morphology: comparison of Healon and Viscoat. J Cataract Refract Surg 27(11):1756–1761. https://doi.org/10.1016/s0886-3350(01)00985-3
Holzer MP, Tetz MR, Auffarth GU, Welt R, Völcker HE (2001) Effect of Healon5 and 4 other viscoelastic substances on intraocular pressure and endothelium after cataract surgery. J Cataract Refract Surg 27(2):213–218. https://doi.org/10.1016/s0886-3350(00)00568-x
Auffarth GU, Auerbach FN, Rabsilber T et al (2017) Comparison of the performance and safety of 2 ophthalmic viscosurgical devices in cataract surgery. J Cataract Refract Surg 43(1):87–94. https://doi.org/10.1016/j.jcrs.2016.10.025
Papaconstantinou D, Karmiris T, Diagourtas A, Koutsandrea C, Georgalas I (2014) Clinical trial evaluating Viscoat and Visthesia ophthalmic viscosurgical devices in corneal endothelial loss after cataract extraction and intraocular lens implantation. Cutan Ocul Toxicol 33(3):173–180. https://doi.org/10.3109/15569527.2013.845835
Liza-Sharmini A (2006) Effect of Healon 5 and Healon GV on corneal endothelial morphology after phacoemulsification surgery. Int Med J 13:281–285
Bissen-Miyajima H (2008) Ophthalmic viscosurgical devices. Curr Opin Ophthalmol 19(1):50–54. https://doi.org/10.1097/ICU.0b013e3282f14db0
Arshinoff S (2000) New terminology: ophthalmic viscosurgical devices. J Cataract Refract Surg 26(5):627–628. https://doi.org/10.1016/s0886-3350(00)00450-8
Arshinoff SA, Jafari M (2005) New classification of ophthalmic viscosurgical devices–2005. J Cataract Refract Surg 31(11):2167–2171. https://doi.org/10.1016/j.jcrs.2005.08.056
Colvard DM (2009) Achieving excellence in cataract surgery a step-by-step approach
Yildirim TM, Auffarth GU, Son HS, Khoramnia R, Munro DJ, Merz PR (2019) Dispersive viscosurgical devices demonstrate greater efficacy in protecting corneal endothelium in vitro. BMJ Open Ophthalmology 4(1):e000227
Park SE, Wilkinson SW, Ungricht EL, Trapnell M, Nydegger J, Brintz BJ, Mamalis N, Olson RJ, Werner L (2022) Corneal endothelium protection provided by ophthalmic viscosurgical devices during phacoemulsification: experimental study in rabbit eyes. J Cataract Refract Surg 48(12):1440–1445. https://doi.org/10.1097/j.jcrs.0000000000001052
Rayner OPHTEIS® FR PRO viscous cohesive biofermented NaHA with sorbitol. Published online 2018. https://rayner.com/wp-content/uploads/2021/11/FR-Pro-Fact-Sheet.pdf. Accessed 22 August 2022
Alcon. VISCOAT* ophthalmic viscosurgical device (sodium chondroitin sulfate—sodium hyaluronate). Published online 2014 http://embed.widencdn.net/pdf/plus/alcon/qzvazbpred/DuoVisc_us_en.pdf?u=4rqn9dAccessed 22 August 2022
Melancia D, Abegão Pinto L, Marques-Neves C (2015) Cataract surgery and intraocular pressure. Ophthalmic Res 53(3):141–148. https://doi.org/10.1159/000377635
Grzybowski A, Kanclerz P (2019) Early postoperative intraocular pressure elevation following cataract surgery. Curr Opin Ophthalmol 30(1):56–62. https://doi.org/10.1097/ICU.0000000000000545
Mansberger SL, Gordon MO, Jampel H et al (2012) Reduction in intraocular pressure after cataract extraction: the ocular hypertension treatment study. Ophthalmology 119(9):1826–1831. https://doi.org/10.1016/j.ophtha.2012.02.050
Zetterström C, Behndig A, Kugelberg M, Montan P, Lundström M (2015) Changes in intraocular pressure after cataract surgery: analysis of the Swedish national cataract register data. J Cataract Refract Surg 41(8):1725–1729. https://doi.org/10.1016/j.jcrs.2014.12.054
Funding
The ophthalmic viscosurgical device FR-Pro was provided by Rayner. No author has a financial or proprietary interest in any material or method mentioned.
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All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by KW. The first draft of the manuscript was written by KW and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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Wood, K., Pessach, Y., Kovalyuk, N. et al. Corneal endothelial cell loss and intraocular pressure following phacoemulsification using a new viscous-cohesive ophthalmic viscosurgical device. Int Ophthalmol 44, 10 (2024). https://doi.org/10.1007/s10792-024-02997-y
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DOI: https://doi.org/10.1007/s10792-024-02997-y