Surgical interventions for presbyopia.

Rationale: Presbyopia is a progressive condition that everyone who lives long enough will experience, irrespective of gender, ethnicity, or economic status. A wide range of surgical options has emerged for overcoming near and intermediate visual impairment; however, questions about the effectiveness and safety of these interventions remain unanswered. Given the global burden of presbyopia and the need to improve decision-making practices in tailoring management and allocating scarce resources, it is essential to review the available evidence on this issue systematically.

Objectives: The primary objective was to compare the effectiveness and safety of surgical interventions for people with presbyopia; the secondary objective was to produce a brief economic commentary summarizing relevant economic evaluations that have compared different surgical interventions.

Search methods: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, two other databases, and trial registries on 29 February 2024.

Eligibility criteria: We included randomized controlled trials in participants with presbyopia, including those who had pseudophakic presbyopia with or without previous corneal refractive surgery, in which one surgical intervention was compared with another or a modified version of the same intervention. We excluded trials that had enrolled participants mainly for cataract surgery or who had other ocular comorbidities such as glaucoma, diabetes mellitus, age-related macular degeneration, or myopic retinopathy.

Outcomes: Outcomes of interest were spectacle independence for near and intermediate vision, change in quality of life (QoL), improvement in or maintenance of binocular uncorrected distance visual acuity (VA), participant satisfaction, change in binocular contrast sensitivity (CS), and frequency of adverse events (AE).

Risk of bias: We used the Cochrane RoB 2 tool to assess bias for each outcome in each included trial.

Synthesis methods: We planned to synthesize results for each outcome using meta-analysis (random-effect models) where possible, or else use synthesis without meta-analysis methods. However, due to insufficient data for each pairwise comparison (i.e. only one study reported data per analysis), we employed narrative synthesis. We used GRADE to assess the certainty of evidence for each outcome.

Included studies: We included four studies that enrolled 300 participants (600 eyes); most participants were women; mean ages ranged between 46 and 58 years. Two trials were conducted in Croatia, one in Egypt, and one in Turkey. Three studies compared a surgical intervention for presbyopia with another, and one study compared a surgical intervention with a modified version of the same intervention. All enrolled participants had presbyopia without cataracts, other comorbidities, or previous ocular surgery. No trials were registered before initiation. One trial reported no funding and no financial conflicts of interest; the others provided no information.

Synthesis of results: Only one study provided data per pairwise comparison of interventions. No study reported outcomes at 12 months or provided economic data. Diffractive bifocal intraocular lens (IOL) versus refractive bifocal IOL after refractive lens exchange (RLE) At six months, the diffractive bifocal IOL group showed no evidence of a difference in spectacle independence for near vision (risk ratio [RR] 1.06, 95% confidence interval [CI] 0.82 to 1.37; 100 participants; low-certainty evidence), intermediate vision (RR 0.93, 95% CI 0.81 to 1.07; 100 participants; low-certainty evidence), or participant satisfaction (RR 1.09, 95% CI 0.99 to 1.19; 100 participants; very low-certainty evidence) compared with refractive bifocal IOL implantation after RLE. Ocular AEs may be less frequent in the diffractive bifocal IOL group (RR [non-event] 1.38, 95% CI 1.05 to 1.81; 100 participants; very low-certainty evidence). Changes in QoL, binocular CS, or binocular uncorrected distance VA were not reported. Diffractive bifocal IOL after RLE versus laser-assisted in situ keratomileusis (LASIK) monovision At six months, diffractive bifocal IOL implantation showed no evidence of a difference compared with LASIK monovision in spectacle independence for near vision (RR 1.07, 95% CI 0.92 to 1.25; 100 participants; low-certainty evidence), the proportion of participants achieving 0.0 LogMAR or better distance vision (RR 0.87, 95% CI 0.69 to 1.11; 100 participants; low-certainty evidence), or improvement in participant satisfaction (RR 0.98, 95% CI 0.89 to 1.07; 100 participants; low-certainty evidence). However, LASIK monovision may improve spectacle independence for intermediate vision at six months (RR 0.82, 95% CI 0.72 to 0.94; 100 participants; low-certainty evidence) and may reduce ocular AE (RR [non-event] 0.58, 95% CI 0.46 to 0.74; 100 participants; very low-certainty evidence). Changes in QoL or binocular CS were not reported. Diffractive trifocal IOL versus extended depth of focus IOL after RLE No data on spectacle independence, participant satisfaction, binocular CS, or ocular AE were reported. At three months after surgery, neither of the two interventions may offer a clinically significant advantage over the other, either for QoL scores (mean difference [MD] -0.08, 95% CI-0.15 to -0.01; 74 participants; very low-certainty evidence) or binocular uncorrected near VA (MD 0.01, 95% CI -0.02 to 0.04; 74 participants), intermediate VA (MD 0.01, 95% CI -0.01 to 0.03; 74 participants) or distance VA (MD 0.01, 95% CI -0.01 to 0.03; 74 participants; low-certainty evidence). Modified wavefront-guided (WG) LASIK versus conventional WG LASIK We found no data for spectacle independence, QoL, participant satisfaction, or ocular AE. Data from one study suggested no evidence of a difference between the interventions in improvement in uncorrected distance VA or change in binocular CS at three months. However, we had concerns about potential bias, and the data were insufficient for quantitative analysis.

Authors' conclusions: The available data were limited to short-term (three months) and mid-term (six months) outcomes and provided low- or very low-certainty evidence. Little information was reported regarding QoL, binocular CS, or ocular AEs; no study addressed economic aspects of interventions.

Funding: This Cochrane review had no internal source of support. External sources: National Eye Institute, National Institutes of Health, USA; Public Health Agency, UK; Queen's University Belfast, UK.

Registration: Protocol (2023): doi.org/10.1002/14651858.CD015711.