BMC ophthalmology · 2026
Hyaluronic acid concentration predictably modulates physicochemical properties and clinical performance in ophthalmic viscosurgical devices: integrated laboratory and prospective clinical assessment.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
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Melero Alejandro, Torrecilla Josune, Pino Ander, Alonso José María, Coello Daniel, Sáez de Arregui Sandra, Garay-Aramburu Gonzaga, López-Plandolit Silvia, Guergué Olaia, Henares Iker, Huguet-Casquero Amaia, Ucelay López de Heredia Miguel, Pérez González Raúl
Аннотация
BACKGROUND: Ophthalmic viscosurgical devices (OVDs) are essential in cataract surgery for maintaining anterior chamber stability and protecting intraocular tissues. This study evaluated the physicochemical and rheological properties of three hyaluronic acid-based OVDs (OpHLINE® 1.4%, 2%, and 3%) and assessed their clinical performance.
METHODS: A two-phase investigation was conducted: (1) characterization of OpHLINE formulations versus four commercial comparators, including cohesive-dispersive analysis and viscosity-shear profiling; and (2) a prospective clinical trial in 68 patients undergoing phacoemulsification with intraocular lens implantation. Primary endpoint was workspace maintenance; secondary endpoints included ease of OVD removal, endothelial cell density (ECD) loss, and intraocular pressure (IOP) changes.
RESULTS: By varying HA concentration at constant molecular weight, we achieved direct control of rheological properties and CDI, generating distinct functional profiles: OpHLINE 1.4% behaved cohesively with rapid aspiration, OpHLINE 3% exhibited dispersive-like retention while maintaining space, and OpHLINE 2% combined cohesive handling with the highest shear-resistant viscosity. Clinically, OpHLINE 2% maintained an intermediate behaviour regarding space maintenance, ease of removal, ECD and IOP, while OpHLINE 3% provided the highest full chamber maintenance during all surgical steps. OpHLINE 1.4% enabled the easiest removal (95% adequate) and the lowest ECD loss (12.9%). IOP spikes ≥ 30 mmHg occurred in 13.6%, 20.8%, and 30.4% of eyes at 6 h for 1.4%, 2%, and 3%, respectively, resolving without sequelae.
CONCLUSION: This study demonstrates that cohesive-dispersive behaviour and shear-dependent viscosity can be predictably tuned by HA concentration alone, enabling a modular, evidence-based approach to OVD selection. OpHLINE series provide evidence for three distinct behaviours: 1.4% showed optimal removal and endothelial protection; 2% offered balanced rheological and clinical properties; 3% provided the most consistent anterior chamber stability during surgery. These results allow surgeons to tailor intraoperative performance without altering polymer chain length.
TRIAL REGISTRATION: This study was retrospectively registered (OpHLINE-PIC01-2020), approved on 8 February 2021 by the Ethics Committee for Research with Medicines of Euskadi (CEIm-E, Spain, code PS2020065).
TRIAL REGISTRATION: ClinicalTrials.gov, NCT ID Number NCT07343973, Registered on 07 January 2026.
METHODS: A two-phase investigation was conducted: (1) characterization of OpHLINE formulations versus four commercial comparators, including cohesive-dispersive analysis and viscosity-shear profiling; and (2) a prospective clinical trial in 68 patients undergoing phacoemulsification with intraocular lens implantation. Primary endpoint was workspace maintenance; secondary endpoints included ease of OVD removal, endothelial cell density (ECD) loss, and intraocular pressure (IOP) changes.
RESULTS: By varying HA concentration at constant molecular weight, we achieved direct control of rheological properties and CDI, generating distinct functional profiles: OpHLINE 1.4% behaved cohesively with rapid aspiration, OpHLINE 3% exhibited dispersive-like retention while maintaining space, and OpHLINE 2% combined cohesive handling with the highest shear-resistant viscosity. Clinically, OpHLINE 2% maintained an intermediate behaviour regarding space maintenance, ease of removal, ECD and IOP, while OpHLINE 3% provided the highest full chamber maintenance during all surgical steps. OpHLINE 1.4% enabled the easiest removal (95% adequate) and the lowest ECD loss (12.9%). IOP spikes ≥ 30 mmHg occurred in 13.6%, 20.8%, and 30.4% of eyes at 6 h for 1.4%, 2%, and 3%, respectively, resolving without sequelae.
CONCLUSION: This study demonstrates that cohesive-dispersive behaviour and shear-dependent viscosity can be predictably tuned by HA concentration alone, enabling a modular, evidence-based approach to OVD selection. OpHLINE series provide evidence for three distinct behaviours: 1.4% showed optimal removal and endothelial protection; 2% offered balanced rheological and clinical properties; 3% provided the most consistent anterior chamber stability during surgery. These results allow surgeons to tailor intraoperative performance without altering polymer chain length.
TRIAL REGISTRATION: This study was retrospectively registered (OpHLINE-PIC01-2020), approved on 8 February 2021 by the Ethics Committee for Research with Medicines of Euskadi (CEIm-E, Spain, code PS2020065).
TRIAL REGISTRATION: ClinicalTrials.gov, NCT ID Number NCT07343973, Registered on 07 January 2026.