Romanian journal of ophthalmology · 2024
Efficacy and safety of the OZil phacoemulsification handpiece in dropped lens fragment surgery: a randomized controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Rana Vipin, Sinha Deependra Kumar, Dangi Meenu, Gupta Atul, Bandopadhyay Sandepan, Kaushik Jaya, Kumar Ashok, Tripathi Amit Nandan
Аннотация
OBJECTIVE: Phacoemulsification is the predominant method for cataract surgery, but complications like lens nuclei dislodgment into the vitreous cavity pose significant risks, including inflammation, glaucoma, retinal tears, and vision loss. Traditional management involves pars plana vitrectomy with phacofragmentation, which can increase the risk of retinal damage due to repulsive forces. This study tests whether the OZil phacoemulsification handpiece, employing torsional movement, offers a safer alternative by minimizing repulsive forces and reducing surgical duration compared to the traditional phacofragmatome.
METHODS: This prospective study, conducted in a tertiary care hospital in eastern India from January to June 2023, enrolled 40 patients with nucleus dislocation during cataract surgery. Patients were randomized into Group 1 (traditional phacofragmatome) and Group 2 (OZil handpiece). Primary objectives included comparing the duration of surgery and intraoperative complications. Secondary objectives assessed postoperative best-corrected visual acuity (BCVA), surgical site safety, and cystoid macular edema (CME) incidence.
RESULTS: Group 2 demonstrated significantly shorter surgical durations (110±2.54 seconds) compared to Group 1 (152±2.23 seconds, p < 0.001). The frequency of nucleus falls was considerably lower in Group 2 (p < 0.001). Postoperative BCVA and CME incidence showed no significant differences between groups. Multiple regression analysis confirmed the OZil handpiece significantly reduced surgical duration (β = -0.40, p < 0.001) without compromising safety.
DISCUSSION: The OZil handpiece's rotational cutting mechanism offers a significant advantage in reducing surgical time while improving the followability of lens fragments, as compared to the traditional phacofragmatome. It addresses one of the key limitations of phacofragmentation by minimizing fragment displacement, where repulsive forces can complicate the procedure. Although both techniques showed similar safety profiles, the OZil handpiece's operational efficiency makes it a promising alternative for managing posteriorly displaced lens fragments in complex cases.
CONCLUSIONS: The OZil phacoemulsification handpiece significantly enhances surgical efficiency and safety in nucleus drop surgeries. Its integration into existing phacofragmatome systems can lead to major advancement in the ophthalmic surgical armamentarium, ensuring improved patient care.
METHODS: This prospective study, conducted in a tertiary care hospital in eastern India from January to June 2023, enrolled 40 patients with nucleus dislocation during cataract surgery. Patients were randomized into Group 1 (traditional phacofragmatome) and Group 2 (OZil handpiece). Primary objectives included comparing the duration of surgery and intraoperative complications. Secondary objectives assessed postoperative best-corrected visual acuity (BCVA), surgical site safety, and cystoid macular edema (CME) incidence.
RESULTS: Group 2 demonstrated significantly shorter surgical durations (110±2.54 seconds) compared to Group 1 (152±2.23 seconds, p < 0.001). The frequency of nucleus falls was considerably lower in Group 2 (p < 0.001). Postoperative BCVA and CME incidence showed no significant differences between groups. Multiple regression analysis confirmed the OZil handpiece significantly reduced surgical duration (β = -0.40, p < 0.001) without compromising safety.
DISCUSSION: The OZil handpiece's rotational cutting mechanism offers a significant advantage in reducing surgical time while improving the followability of lens fragments, as compared to the traditional phacofragmatome. It addresses one of the key limitations of phacofragmentation by minimizing fragment displacement, where repulsive forces can complicate the procedure. Although both techniques showed similar safety profiles, the OZil handpiece's operational efficiency makes it a promising alternative for managing posteriorly displaced lens fragments in complex cases.
CONCLUSIONS: The OZil phacoemulsification handpiece significantly enhances surgical efficiency and safety in nucleus drop surgeries. Its integration into existing phacofragmatome systems can lead to major advancement in the ophthalmic surgical armamentarium, ensuring improved patient care.