Mousavi Seyed Abolghasem, Rajavi Zhale, Sabbaghi Hamideh, Abdi Saeid, Montazerin Nafeeseh, Kheiri Bahareh, Haseli-Mofrad Azadeh, Sheibani Kourosh, Jaldian Hemn Baghban
Negah Aref Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Ophthalmology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
J Ophthalmic Vis Res. 2024 Dec 31;19(4):468-475. doi: 10.18502/jovr.v19i4.14578. eCollection 2024 Dec.
To assess the efficiency and safety of pilocarpine eye drop 1.25% analogue (IR- Pilo) in comparison with its original brand-name drug (Vuity).
In this non-randomized comparative study, 75 patients with presbyopia aged 40 to 60 years were enrolled. The right eyes of these patients received either IR-Pilo ( = 45) or Vuity ( = 30) and their contralateral eyes served as controls. Refractive errors, distance best-corrected visual acuity (BCVA), near vision, amplitude of accommodation, pupil size, and intraocular pressure (IOP) were measured before and 1 to 2 hours after instillation of the eye drop.
The mean refractive error was stable, except for a small myopic shift in the Vuity group. There was no significant change in distance BCVA. Near vision improved significantly in both intervention groups ( 0.001) with preference for IR-Pilo (4 vs 2.3). Furthermore, a higher amplitude of accommodation and pupil constriction occurred after instillation of both drops, with a higher effect associated with IR-Pilo. However, IOP did not change significantly post intervention.
IR-Pilo and Vuity eye drops had comparable results; both were effective and led to stable distance vision and improved near vision. Both ophthalmic drugs were safe and none of them were associated with significant adverse effects.
评估1.25%毛果芸香碱滴眼液类似物(IR - 毛果芸香碱)与其原研品牌药物(Vuity)相比的有效性和安全性。
在这项非随机对照研究中,纳入了75例年龄在40至60岁的老花眼患者。这些患者的右眼接受IR - 毛果芸香碱(n = 45)或Vuity(n = 30)治疗,对侧眼作为对照。在滴眼药水前及滴药后1至2小时测量屈光不正、最佳矫正远视力(BCVA)、近视力、调节幅度、瞳孔大小和眼压(IOP)。
除Vuity组有小幅度近视偏移外,平均屈光不正稳定。远视力BCVA无显著变化。两个干预组的近视力均显著改善(P < 0.001),且更倾向于IR - 毛果芸香碱(4 logMAR vs 2.3 logMAR)。此外,两种滴眼液滴入后均出现更高的调节幅度和瞳孔收缩,IR - 毛果芸香碱的效果更明显。然而,干预后眼压无显著变化。
IR - 毛果芸香碱滴眼液和Vuity滴眼液结果相当;两者均有效,可使远视力稳定并改善近视力。两种眼科药物均安全,且均未出现显著不良反应。