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Effectiveness of SMILE Combined with Micro-Monovision in Presbyopic Patients: A Pilot Study.

ABSTRACT: Binocular summation along all defocus range after a micro-monovision procedure has scarcely been studied. The aim of this pilot study was to evaluate the efficacy of SMILE combined with different levels of micro-monovision in presbyopic patients and to assess the binocular summation effect on contrast sensitivity defocus curves (CSDC) at the 6-month follow-up. Efficacy was assessed on the basis of visual acuity (VA) and stereopsis at far, intermediate, and near distances. Patient-reported outcomes (PROs) and binocular CSDC were also evaluated. Six patients completed the study with a programmed median anisometropia of 0.81 Diopter. The median binocular uncorrected VA was better than 0 logMAR at the three evaluated distances, and stereopsis was not impaired in any patient, achieving a median of ≤119 arcsec at any distance. CSDC increased binocularly after surgery, significantly in the range of -2 to -3 D (p < 0.05). No clinically relevant changes were observed in PROs compared with the preoperative period, and all patients achieved spectacle independence at intermediate/near distance and were likely or very likely to undergo the same surgery. In conclusion, micro-monovision with SMILE could be an effective procedure, with results that might be comparable to other laser correction techniques specifically designed for presbyopia correction.

SUBMITTER: Fernandez J

PROVIDER: S-EPMC10051050 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Effectiveness of SMILE Combined with Micro-Monovision in Presbyopic Patients: A Pilot Study.

Fernández Joaquín J Alonso-Aliste Federico F Burguera Noemí N Hernández-Lucena Julia J Amián-Cordero Jonatan J Rodríguez-Vallejo Manuel M

Life (Basel, Switzerland) 20230320 3

Binocular summation along all defocus range after a micro-monovision procedure has scarcely been studied. The aim of this pilot study was to evaluate the efficacy of SMILE combined with different levels of micro-monovision in presbyopic patients and to assess the binocular summation effect on contrast sensitivity defocus curves (CSDC) at the 6-month follow-up. Efficacy was assessed on the basis of visual acuity (VA) and stereopsis at far, intermediate, and near distances. Patient-reported outcom ...[more]

PMID: 36983993

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Project description:PurposeContemporary monovision techniques use premium intraocular lenses (IOLs), either in both eyes or at least in the non-dominant one. Primary objective of this study was to compare the efficacy of premium monovision (implantation of the trifocal diffractive Panoptix IOL in the non-dominant eye and the bifocal hybrid refractive-diffractive Restor IOL in the dominant eye), against bilateral myopic monovision (implantation of the monofocal SN60WF IOL targeting -0.50 D in the dominant eye and -1.25 D myopia in the non-dominant one), hybrid monovision (implantation of Panoptix in the non-dominant eye and SN60WF in the dominant eye) and bilateral trifocal implantation (with bilateral Panoptix implantation).MethodsThis is a prospective, comparative, clinic-based trial. Cataract patients populated four study groups: Monovision Group (MoG), Multifocal Lens Group (MfG), Hybrid Monovision Group (HmG) and Premium Monovision Group (PmG). Binocular Uncorrected Distance Visual Acuity (UDVA), Uncorrected Reading Acuity and Critical Print Size at 60cm (UIRA, UICPS) and at 40cm (UNRA, UNCPS), contrast sensitivity, vision-related functional impairment, dysphotopsia symptoms and spectacle dependence were evaluated 6 months following the operation of the second eye. A mathematical model was constructed, which calculated the relative efficacy of each surgical intervention.ResultsA total of 120 participants were recruited and populated equally the study groups. Significant improvement of preoperative UDVA was observed in all study groups. No significant differences could be detected in postoperative UDVA and UIRA (p = 0.24) among study groups, while significant differences were noticed in UICPS (p = 0.04), UNRA (p = 0.02) and UNCPS (p = 0.01). Dysphotopic phenomena (glare and shadows) were significantly more in the MfG arm followed by the PmG group (p = 0.04 and p = 0.02, respectively), while perceived difficulty and spectacle independence rates were significantly better in PmG group. PmG presented the best overall relative efficacy.ConclusionAll surgical techniques present satisfactory outcomes. Premium monovision seems to demonstrate the best outcomes.Trial registrationClinicalTrials.gov, NCT04618380. Registered 05 November 2020, https://clinicaltrials.gov/ct2/show/NCT04618380.

Project description:Background and Objectives: This pilot study aimed to evaluate the clinical effectiveness, cost-effectiveness, and safety of acupotomy combined with epidural steroid injection (ESI) in lumbosacral radiculopathy and examine its feasibility for the main study. Materials and Methods: This randomized, controlled, two-arm, parallel, assessor-blinded, pragmatic study included 50 patients with severe lumbosacral radiculopathy who had insufficient improvement after an ESI. Patients were randomized (1:1 ratio) into a combined treatment (acupotomy + ESI, experimental) and an ESI single treatment (control) group. Both groups underwent a total of two ESIs once every 2 weeks; the experimental group received eight additional acupotomy treatments twice a week for 4 weeks. Types of ESI included interlaminar, transforaminal, and caudal approaches. Drugs used in ESI comprised a 5-10 mL mixture of dexamethasone sodium phosphate (2.5 mg), mepivacaine (0.3%), and hyaluronidase (1500 IU). The primary outcome was the difference in changes from baseline in the Oswestry Disability Index (ODI) scores between the groups at weeks 4 and 8. The incremental cost-utility ratio (ICUR) was calculated to evaluate the cost-effectiveness between the groups. Adverse events (AEs) were assessed at all visits. Results: Mean ODI scores for the experimental and control groups were -9.44 (95% confidence interval [CI]: -12.71, -6.17) and -2.16 (95% CI: -5.01, 0.69) at week 4, and -9.04 (95% CI: -12.09, -5.99) and -4.76 (95% CI: -7.68, -1.84) at week 8, respectively. The difference in ODI score changes was significant between the groups at week 4 (p = 0.0021). The ICUR of the experimental group versus the control group was as economical as 18,267,754 won/quality-adjusted life years. No serious AEs were observed. Conclusions: These results demonstrate the potential clinical effectiveness and cost-effectiveness of acupotomy combined with ESI for lumbosacral radiculopathy and its feasibility for a full-scale study. Larger, long-term follow-up clinical trials are needed to confirm these findings.

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Dataset Information

Effectiveness of SMILE Combined with Micro-Monovision in Presbyopic Patients: A Pilot Study.

Publications

Effectiveness of SMILE Combined with Micro-Monovision in Presbyopic Patients: A Pilot Study.

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