Safety and Perioperative Outcomes of Immediate Versus Delayed Sequential Bilateral Cataract Surgery in the Pediatric Population: A Systematic Review and Meta-Analysis

Abstract

Background: Bilateral congenital cataracts are a major cause of preventable childhood blindness. Although delayed sequential bilateral cataract surgery (DSBCS) has traditionally been the preferred approach, immediate sequential bilateral cataract surgery (ISBCS) is increasingly being considered to reduce anesthesia exposure and healthcare burden.

Method: We performed a systematic review and meta-analysis on four studies involving 224 patients. A comprehensive literature search was conducted on PubMed, Embase, Cochrane Library, and ScienceDirect. Analysis was conducted on RevMan 5.4. Moreover, the risk of bias was assessed via RoB 2.0. The primary outcomes were operating room (OR) time, procedure time, anesthesia-related complications, number of follow-up visits, and incidence of postoperative glaucoma.

Results: ISBCS was associated with significantly shorter OR time compared with DSBCS (mean difference, −34.69 min; p < 0.001). There were no significant differences in procedure time or anesthesia-related complications between groups. Postoperative glaucoma incidence was significantly lower in the ISBCS group (odds ratio, 0.34; p = 0.02). Follow-up visit burden was comparable between the two approaches.

Conclusion: In pediatric patients with bilateral congenital cataracts, ISBCS was associated with reduced OR time and a lower risk of postoperative glaucoma without increasing intraoperative risks. These findings support the consideration of ISBCS as a safe and effective surgical option in appropriately selected pediatric cases. However, these results should be considered with caution due to heterogeneity and lack of prospective cohort studies and further research in this field is warranted.

Graphical abstract

Keywords

bilateral cataract surgery / general anesthesia / operation room time / treatment related adverse effects

1 Introduction

Pediatric cataract is an important cause of treatable childhood blindness. Common presenting signs in children include leukocoria, strabismus, and nystagmus [1]. It can be congenital or acquired [2], and ranks as the second most common cause of blindness worldwide, following adult-onset cataracts [3]. The global prevalence of congenital cataracts ranges from 0.63 to 9.74 per 10,000 with incidence ranging from 1.8 to 3.6 per 10,000 children annually. Its prevalence is significantly higher in high-income countries, ranging from 0.63 to 13.6 per 10,000 [4].

Management has been done through delayed sequential surgery in the past where one eye is operated first, and then the second eye with a gap of several weeks [5]. On the other hand, immediate sequential requires both eyes to be operated on the same day, in the same general anesthesia (GA). It was not commonly practiced due to the perceived risk of dreadful complications like endophthalmitis and toxic anterior segment syndrome (TASS) [6].

The primary advantage seen in the immediate sequential bilateral cataract surgery (ISBCS) group is reduced need for GA. A study analyzed the risk of developmental delay (DD) in the children who undergone multiple GA exposures, and showed increased risk with repeated exposure: hazard ratio (HR) 1.145 for one event, 1.476 for two events, and 2.222 for three or more events (p < 0.05 for all) [7].

ISBCS was not widely practiced in the USA due to concerns of bilateral endophthalmitis [5]. But, proponents of ISBCS emphasize low rates of complications such as endophthalmitis [8], along with potential advantages including reduced need for multiple preoperative assessments, minimized travel and follow-up burden [5,9].

There is a paucity of literature on the pooled comparison of effect sizes of ISBCS versus delayed sequential bilateral cataract surgery (DSBCS) in the younger population that warrants the need for this meta-analysis.

2 Methods

This systematic review and meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines to ensure methodological rigor and transparency in reporting [10]. Prior to conducting this review, the study protocol was prospectively submitted and registered with PROSPERO (International Prospective Register of Systematic Reviews), with the assigned registration number CRD420251039509.

2.1 Data Sources and Searches

A comprehensive and systematic literature search was conducted across four major electronic databases—PubMed, Cochrane Library, ScienceDirect, and Embase—from their inception through April 25, 2025. The search strategy employed a combination of controlled vocabulary and free-text terms, including the keywords “cataract surgery,” “cataract extraction,” “Immediate Sequential Bilateral Cataract Surgery,” “ISBCS,” “Delayed Sequential Bilateral Cataract Surgery,” “DSBCS,” and their synonymous or related terms. Boolean operators “AND” and “OR” were utilized to optimize the sensitivity and specificity of the search. In addition, a manual search of the reference lists from previously published meta-analyses and systematic reviews was performed to identify any potentially eligible studies not captured through the electronic search. The complete search strategy is detailed in Supporting Information S1.

2.2 Eligibility Criteria

We included all the studies that fulfilled the following criteria: (1) study designs: clinical trials; (2) population: pediatric population (less than or equal to 12 years); (3) intervention: immediate sequential bilateral cataract surgery; (4) comparator: delayed sequential bilateral cataract surgery; and (5) outcomes: any clinical outcome. Case reports, review articles, and meta-analyses were excluded.

2.3 Study Selection and Data Extraction

Data extraction was performed independently by two reviewers using a standardized data collection form developed in Google sheets. Extracted variables included key study characteristics (year of publication, first author), study design, intervention, comparator, location, individual sample size, follow-up duration, female-to-male ratio, number of eyes, mean age, the interval between surgeries, intraocular lens (IOL) implantation, the American Society of Anesthesiologists (ASA) grade in each group, systemic syndromes, familial cataracts, and relevant common outcomes were retrieved.

2.4 Outcomes

The primary outcomes were intraoperative outcomes including operation room time (OR time), procedure time, anesthesia-related complications, and intraoperative iris injury. Postoperative outcomes included number of follow-up visits and glaucoma.

3 Results

3.1 Systematic Process of Study Selection

A total of 54 records were identified through systematic searches of four electronic databases: PubMed (n = 29), Cochrane Library (n = 3), ScienceDirect (n = 9), and Embase (n = 13). After 13 duplicate records were removed, 41 unique studies remained for initial screening. Titles and abstracts were reviewed for relevance, excluding 33 records that did not fulfill the predefined eligibility criteria. The full texts of the remaining eight articles were retrieved and assessed for eligibility. Four were excluded—two due to an incorrect population (e.g., patients older than 12 years or non-pediatric cases) and two for lacking a proper comparator (i.e., not directly comparing ISBCS with DSBCS). Four studies met all inclusion criteria and were incorporated into the final systematic review and meta-analysis (Figure 1).

3.2 Summary of Reviewed Articles

This systematic review and meta-analysis included four studies—one randomized controlled trial (RCT) and three retrospective observational studies [5,6,11,12]—comprising 224 pediatric patients who underwent bilateral cataract surgery. The total number of eyes operated on was 248 in the ISBCS group and 200 in the DSBCS group, indicating a comparable surgical burden between groups. The studies compared ISBCS and DSBCS in children across diverse geographic settings—Israel, India, Canada, and the USA. All employed retrospective designs and reported baseline demographic and surgical variables. The mean age at surgery was under 3 years across all cohorts. Baseline study and patient characteristics are summarized in Table 1.

3.3 Intraoperative Outcomes

We analyzed intraoperative outcomes, including operating room time, procedure duration, intraoperative iris injury, and anesthesia-related complications. We analyzed three studies reporting operation room time and found a pooled mean difference of −34.69 min (95% CI: −48.20 to −21.19; p < 0.001), favoring the ICSBS group. Substantial heterogeneity was present (I² = 59%, τ² = 82.56, χ² = 4.84, p_h = 0.09). However, the pooled mean difference in procedure time was −3.68 min (95% CI: −16.08 to 8.72; p = 0.56), indicating no statistically significant difference between the ICSBS and DSBCS groups. Intraoperative iris injury and anesthesia-related complications were comparable between the two groups. The pooled odds ratio (OR) for intraoperative iris injury was 0.66 (95% CI: 0.12 to 3.54; p = 0.63), while for anesthesia-related complications it was 0.73 (95% CI: 0.13 to 4.25; p = 0.73), indicating no statistically significant differences (Figure 2).

3.4 Postoperative Outcomes

Postoperative outcomes, including glaucoma and the number of follow-up visits, were analyzed in this meta-analysis. Pooled across two studies, the odds ratio for glaucoma was 0.34 (95% CI: 0.14–0.83), significantly favoring the ICSBS group (p = 0.02). Heterogeneity was moderate (I² = 49%, χ² = 1.97, df = 1, p = 0.16). Our meta-analysis found a statistically significant lower odds of postoperative glaucoma in the ISBCS group. However, this finding should be interpreted with caution, as it is based on only two studies with relatively small sample sizes and limited follow-up. Differences in postoperative surveillance protocols, and potential confounding factors, such as baseline ocular characteristics or surgical complexity, may have influenced this result.

The number of follow-up visits between the two groups was comparable, with a pooled mean difference of −1.83 (95% CI: −4.91 to 1.24; p = 0.24) (Figure 3).

Table 2 displays a comprehensive overview of all intraoperative and postoperative outcomes with their associated results.

3.5 Risk of Bias Assessment

Two of the three non-RCTs were of high quality, while the RCT raised some concerns regarding the risk of bias, as assessed by ROB 2.0 (Figure 4).

3.6 Sensitivity Analysis

One intraoperative outcome (i.e., anesthesia-related complications) and one postoperative outcome of several follow-ups showed substantial heterogeneity (I² > 60%). We conducted a sensitivity analysis for Anesthesia-related complications by sequentially removing each study. Upon exclusion of Agrawal et al. [12], I² was not changed, upon removal of either Bhambhwani et al. [6] or Wondem et al. [11] I² was not applicable as less than 2 studies remained in the analysis. For a number of follow-ups, upon removal of Agrawal et al. [12] the I² reduced to 89%, upon removal of Bhambhwani et al. [6] I² increased to 97%, and finally, upon removal of Wondem et al. [11], I² reduced to 89%.

3.7 Publication Bias

According to the recommended methodological guidelines, formal evaluation of publication bias using Egger's test was not performed, as such statistical approaches are considered unreliable in meta-analyses with fewer than 10 included studies [13].

4 Discussions

Our meta-analysis pooled data from pediatric studies comparing ISBCS to DSBCS and found that ISBCS offered significant efficiencies without compromising safety.

4.1 OR Time and Anesthesia Exposure

Intraoperative measures such as total OR time and anesthesia exposure were substantially reduced with ISBCS. ISBCS reduced OR time by an average of about 30–35 min per child, reflecting the savings of performing both eyes under a single anesthesia session, whereas individual procedure durations were essentially unchanged [11]. Bhambhwani et al. found consistent findings with a mean OR time of 3.6 h in the ISBCS group versus 4.1 h in DSBCS (p = 0.037), while total surgical time per eye was similar between groups [6]. Likewise, Wondem et al. [11] reported significantly shorter anesthesia time for ISBCS cases (p < 0.001) with comparable surgical durations. In our analysis, this translated into a pooled mean difference of −34.7 min favoring ISBCS for OR time (p < 0.001) but a non-significant—3.7 min change in procedure time. These findings demonstrate that one combined session reduces cumulative anesthesia exposure and OR occupancy. In practical terms, shorter OR use per patient enhances surgical throughput and reduces cost, an important consideration in high-volume or resource-limited pediatric centers as documented by Naderi et al. [14].

A separate consideration is anesthesia exposure. Pediatric cataract surgery under GA carries risks, both immediate (e.g., cardiorespiratory events) and potentially long-term neurodevelopmental effects of repeated exposures as documented by Nanavati et al. [15]. By consolidating two surgeries into one anesthetic, ISBCS eliminates the risks inherent in a second induction. The syndromic-infant case report by Nanavati et al. [15] highlights this benefit. An infant with multiple comorbidities underwent simultaneous bilateral lens surgery to minimize anesthesia exposures given airway and cardiac challenges. The authors emphasize that with adequate aseptic measures and separate surgical teams and trays, simultaneous surgery may be a safe and useful approach when anesthesia risk is high.

In settings where specialist anesthesia resources are scarce or patient risk is elevated, the ability to halve anesthetic episodes is a compelling advantage. In fact, during the COVID-19 pandemic, centers that adopted ISBCS in adults noted fewer hospital visits and exposures without compromising outcomes as shown by Chen et al. [16].

4.2 Safety Profile

We found no differences in intraoperative or anesthesia-related complications between ISBCS and DSBCS groups. In our pooled analysis, intraoperative iris injury and anesthesia complications were rare and statistically indistinguishable between ISBCS and DSBCS. For example, Bhambhwani's large series of infants noted no major surgical or anesthetic complications in either group, and Wondem likewise found comparable rates of intraocular and anesthesia-related issues with no cases of endophthalmitis in either arm [6,11]. It aligns with a previous study by Eibenberger et al. in Austria reporting that complication rates including iris trauma were very low and not significantly different between bilateral simultaneous and staged surgeries [17]. Adult data from a high-volume tertiary center in South Korea during the COVID-19 pandemic further reinforce our pediatric conclusions. Hong et al. reviewed 441 cataract surgeries; 322 immediate bilateral and 119 unilateral, and found that, despite worse baseline vision in the unilateral group, postoperative visual acuity was virtually identical, and absolute refractive error did not differ and complication rates were equivalent, with no increase in endophthalmitis or other serious events [18]. The fear of bilateral disaster such as bilateral endophthalmitis is feared greatly, but even in large adult registry studies the incidence of postoperative endophthalmitis is extremely low and similar between ISBCS and DSBCS as documented by Lacy et al. [19]. While pediatric data on this endpoint are sparse, the available pediatric case series by Totan et al. shows no bilateral infections, or serious adverse outcomes, suggesting that with strict aseptic precautions the risk of complications can be minimized [20].

Our meta-analysis also found a significantly lower risk of postoperative glaucoma or raised intraocular pressure in ISBCS (OR approximately 0.34, p = 0.02). One possible explanation is that DSBCS patients may have had two separate postsurgical inflammatory events, cumulatively increasing glaucoma risk. Bhambhwani et al. reported that raised IOP occurred in 7% of eyes after ISBCS versus 25% after DSBCS (p = 0.009) [6]. This finding is in contrast with Eibenberger et al. [17] who found no significant difference between the two groups in the pediatric population as glaucoma occurred in 15%–16% of eyes in both immediate and delayed bilateral groups. In contrast, RCT by Sarikkola et al. in the adult population reported no such complication [21]. These discrepancies show that the evidence is still limited. Given the small number of studies in our meta-analysis, the apparent glaucoma benefit should be interpreted cautiously.

In a large meta-analysis of the adult population of over 11 million patients, there were no significant differences between ISBCS and DSBCS in the proportion of eyes achieving visual acuity > 20/40 or in refractive accuracy (spherical equivalent within ± 0.50 D). Likewise, rates of postoperative endophthalmitis and cystoid macular edema showed no increase with ISBCS, reinforcing our pediatric safety profile. While nonrandomized adult cohorts did reveal a modestly elevated posterior capsule rupture risk (RR 1.34, 95% CI: 1.08–1.67), this low-certainty signal underscores the importance of meticulous aseptic separation and patient selection.

4.3 Postoperative Visits and Follow-Up

Another outcome of interest was the number of postoperative visits. Our pooled mean difference slightly favored ISBCS but did not reach statistical significance. Bhambhwani et al. found that ISBCS patients required significantly fewer follow-up visits than DSBCS patients (mean 4 vs. 6; p = 0.0002) [6]. It aligns with a published study by Chen et al. reporting 5.9 visits on average for ISBCS versus 9.5 for DSBCS (a reduction of 3.5 visits, p < 0.001) [16], underscoring the burden that two separate surgeries impose. In contrast, Wondem et al. found the number of visits to be comparable between groups [11]. This discrepancy may reflect differences in practice settings and follow-up protocols. In any case, fewer hospital visits with ISBCS can reduce healthcare utilization and lessen the burden on families. Agrawal et al. [12] also reported that ISBCS dramatically reduced system burdens as ISBCS cases had 43% fewer visits and 39% shorter OR occupancy than DSBCS, with no major surgical or anesthetic complications in either arm [22]. Moreover, Agrawal et al. [12] found that over one-fifth of the children randomized to the staged (DSBCS) arm failed to return for the second eye surgery, illustrating a real-world risk of DSBCS such as delays or losses to follow-up leading to amblyopia so single sitting surgery can be patient-friendly and cost-effective when precautions are taken.

Moreover, adult economic analyses demonstrate substantial reductions in overall OR time, follow-up visits, and hospital costs with ISBCS; advantages that are arguably even more impactful in pediatrics [22]. Beyond clinical outcomes, patient satisfaction with ISBCS is remarkably high in adult populations. A large Polish survey of 195 ISBCS recipients reported that over 94% were satisfied, and nearly 90% would choose or recommend ISBCS again [23].

In short, ISBCS in children significantly reduces overall OR and anesthesia time, by roughly half an hour per patient, without increasing intraoperative or anesthetic complications. Postoperative outcomes are at least equivalent, with some evidence suggesting lower rates of raised IOP and fewer follow-up visits. By consolidating two procedures into one session, ISBCS enhances surgical throughput, lowers costs, and mitigates risks associated with multiple anesthetic exposures. These benefits are especially compelling in high-volume or resource-limited pediatric settings, supporting ISBCS as a safe, efficient alternative to staged cataract surgery.

4.4 Limitations

Despite illuminating findings, our analysis has limitations. The number of included studies and total patients is small, reflecting the relative paucity of pediatric ISBCS research. The retrospective design of included studies introduces selection bias and variability in outcome reporting. Heterogeneity was notable: study designs, surgical techniques, follow-up schedules, and outcome definitions varied. Although random-effects models and sensitivity analyses were used to mitigate these issues, the findings should be interpreted with caution. Larger, well-designed prospective studies with standardized outcome reporting are needed to confirm these results. For example, “OR time” was not uniformly defined for example some centers measure from induction to recovery, others skin-to-skin surgery time. The glaucoma outcome combined different definitions of elevated IOP and had moderate heterogeneity. Geographic variability such as studies from Israel, India, Canada, and the USA may limit generalizability, although it also suggests applicability across diverse settings. We also lacked data on some relevant endpoints such as visual acuity outcomes, refractive results, quality-of-life measures, and very long-term complications. Follow-up durations were typically short, around 1–5 years, so late-onset issues for example, late glaucoma, retinal detachment, cannot be assessed. Finally, publication bias cannot be excluded; centers with adverse experiences might be reluctant to report. A further limitation is that most of the included studies reported continuous outcomes as medians or total ranges rather than means and standard deviations. To permit pooling, we therefore converted these medians and ranges into estimated means and SDs using the Hozo et al. method [24], which may introduce imprecision, particularly when sample sizes are small or distributions are skewed.

4.5 Future Directions

Given the small number of pediatric ISBCS studies, further research is essential. We recommend a large, prospective trial or multicenter registry with uniform outcomes and extended follow-up to capture long-term visual acuity, amblyopia rates, refractive results, and quality-of-life measures. Monitoring late complications such as pediatric glaucoma or retinal pathology over many years will clarify safety profiles. In addition, qualitative surveys of parent satisfaction and cost-effectiveness analyses across different health systems, especially in low-resource settings, could guide policy. Finally, studying subgroups such as syndromic infants or varying age cohorts, may reveal which children derive the greatest benefit from ISBCS.

5 Conclusion

ISBCS in pediatric patients has shown considerable clinical advantages over DSBCS. This meta-analysis reveals that ISBCS significantly reduces total OR time, lower anesthesia exposure, and decrease healthcare resource utilization. Furthermore, ISBCS is associated with a lower incidence of postoperative glaucoma, suggesting a potentially safer long-term ocular outcome when both eyes are treated simultaneously.

Importantly, the analysis showed no significant increase in intraoperative complications with ISBCS compared to DSBCS, addressing a primary concern regarding the safety of operating on both eyes during the same session. These findings support the adoption of ISBCS as an effective strategy for managing bilateral congenital cataracts in carefully selected pediatric patients. The approach not only optimizes surgical and economic outcomes but may also contribute to faster visual rehabilitation and improved quality of life for.

Further large-scale, prospective studies are recommended to validate these findings and to establish standardized guidelines for patient selection, surgical protocols, and postoperative management in pediatric ISBCS.

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