Jul 2026· International Journal of Clinical Trials· Vol 13, pp. 290-298· 0 citations· 26 references
TL;DR
Unilateral administration of 0.5% pilocarpine is an effective and safe strategy for presbyopia management, providing meaningful binocular visual function and improved reading ease and reduced dependance on near correction in the majority of participants.
Abstract
Background: The objective of the study was to evaluate the feasibility, efficacy, and patient tolerance of unilateral instillation of 0.5% pilocarpine for near vision improvement in presbyopic individuals.
Methods: This prospective interventional study included 130 eyes of 65 presbyopic individuals. A single drop of 0.5% pilocarpine was instilled in one eye of each participant once daily. Distance corrected near visual acuity was assessed uniocularly and binocularly on the 7th and 15th day following initiation of treatment. Subjective improvement in near vision was recorded using patient feedback on comfort and functional near tasks. Binocular vision, stereopsis, and patient- reported outcomes regarding reading comfort, glare, headache, and overall satisfaction were documented at each visit. After completion of 15 days, the same protocol was repeated in the fellow eye of the patient, following a unilateral sequential treatment approach. Statistical analysis was performed using paired t-test and Wilcoxon signed-rank test, as appropriate.
Results: The results demonstrated a clear and progressive improvement in near visual acuity over the two-week period with unilateral administration of 0.5% pilocarpine. Subjective assessment revealed improved reading ease and reduced dependance on near correction in the majority of participants. The treatment was well tolerated. Reported ocular side effects were mild and transient, including brow ache and mild dimming of vision, with no serious adverse effects recorded.
Conclusions: Unilateral administration of 0.5% pilocarpine is an effective and safe strategy for presbyopia management, providing meaningful binocular visual function. Sequential unilateral treatment may offer a practical, patient-friendly non-surgical option for presbyopia management.
Background Presbyopia is an age‐related condition that affects near vision and daily activities. Although several correction methods are available, each has certain limitations, leading to interest in pharmacologic alternatives such as pilocarpine eye drops. This study evaluates the safety and clinical effectiveness of 1% pilocarpine eye drops, as data on its use remain limited. Material and Method A triple‐blinded clinical trial was conducted in 2024 in Yazd, Iran, enrolling 60 presbyopic patients aged 40–60 years. The study was approved by the Iranian Registry of Clinical Trials. Participants received either 1% pilocarpine eye drops or a placebo daily for 30 days. Their visual acuity—both near and distance—was assessed under mesopic conditions at six intervals. Throughout the trial, any side effects and treatment satisfaction were monitored. Statistical analysis was performed, considering results significant if p < 0.05. Results In this study, the treatment group demonstrated a significant improvement in uncorrected near visual acuity (UNVA) at all follow‐ups compared to the placebo group, peaking 1 hour after treatment (p ≤ 0.001). Although a significant change in uncorrected distance visual acuity (UDVA) from baseline was observed within the treatment group, no significant between‐group difference in UDVA was found at the 30‐day follow‐up. Overall, patient satisfaction was significantly higher in those receiving pilocarpine (p ≤ 0.001). Discussion This study supports previous research by showing improvements in UNVA, a quick onset of effects, and an acceptable safety profile. However, there was a slight worsening in UDVA; this may be due to higher initial measurements or temporary effects. Unlike many past trials, this study utilizes a rigorous triple‐blinded design and measures effects at six different times, giving a thorough look at both the onset and duration of effects. Conclusion A 1% pilocarpine treatment has been found to significantly improve near vision in presbyopic patients, with minimal side effects and high patient satisfaction. Trial Registration: Iranian Registry of Clinical Trials (IRCT): IRCT20240325061363N1
Mohsen Gohari, Mohammad Hosein Abootorabi, Fateme Heidari· Journal of Ophthalmology· 0 citations
Presbyond LBV provides durable long-term visual and refractive outcomes, excellent binocular distance and near visual acuity, and a high degree of spectacle independence in appropriately selected presbyopic patients, however, outcomes differed according to baseline refractive status.
Ewelina Trojacka, J. Izdebska, J. Przybek-Skrzypecka et al.· Journal of Clinical Medicine· 0 citations
Luminopia demonstrated significant improvements in Registry patients with severe amblyopia, particularly in treatment-naive patients, supporting its use as a viable treatment option that may address key limitations of traditional approaches.
Courtney L. Kraus, A. Godfrey, E. Gaier et al.· Journal of AAPOS· 1 citation
Purpose To evaluate the safety and efficacy of the VIS Optimal Keratoplasty device and procedure for treating eyes with hyperopia and hyperopic presbyopia to achieve uncorrected distance visual acuity (UDVA) and uncorrected near visual acuity (UNVA) improvements. Setting Bahamas Vision Centre, Nassau, New Providence, The Bahamas. Methods 114 eyes of 57 patients with low to moderate hyperopic presbyopia (MRSE = 0.88 to 3.25 D; mean add ± standard deviation (SD) = 2.08 ± 0.43 D) received primary treatments (Txs) by the VIS NTK Optimal Keratoplasty device; 44 and 22 patients also received secondary and ternary Txs, respectively. Patients were treated to produce best UDVA and best UNVA in both eyes using a multifocal vision protocol. Safety and efficacy measures with follow-up (f/u) extending to 24 months post-Tx were analyzed. Results Safety – There were no clinically significant adverse events or complications. Efficacy – Geometric mean (gm) ± SD binocular UDVA improvements corresponded to 3.6 ± 3.9 lines gained at 1 day post-primary Tx (p < 0.01), with gradual reduction of improvement to 1.7 ± 2.1 lines gained at 24m′ post-secondary Tx. Gm binocular UNVA improvements peaked at 4.8 ± 2.9 lines gained at 1 day post-primary Tx (p < 0.01), with gradual reduction to 1.1 ± 2.6 lines gained at 24m′ post-secondary Tx. The mean durations of “functional” (>20/40) binocular UDVA and UNVA were over 2 years and ca. 6 months post-Tx, respectively. Conclusions Optimal keratoplasty appears to be safe and efficacious for improving both UDVA and UNVA in eyes with hyperopic presbyopia, The procedure is noninvasive, simple, rapid, comfortable and repeatable. UDVA improvement is long lasting (2 years or more), although UNVA improvement is temporary. Additional optimal keratoplasty Txs can be repeated whenever needed to maintain functional UNVA.
Kenneth Jonathan Rodgers, H. Glen, Michael J. Berry· Clinical Ophthalmology· 0 citations
SMILE with micro-monovision had an impact on accommodative function in the early postoperative stage in myopic patients with presbyopia, and patients exhibited good distance and near vision, maintained binocular visual functions, and reported high subjective satisfaction.
N. Li, Y. Lyu, Y. Song et al.· [Zhonghua yan ke za zhi] Chi...· 0 citations