|Year : 2015 | Volume
| Issue : 3 | Page : 362-369
Meta-analysis to compare the safety and efficacy of manual small incision cataract surgery and phacoemulsification
Parikshit Gogate1, Jyoti Jaggernath B Optom2, Swapna Deshpande3, Kovin Naidoo2
1 African Vision Research Institute, Durban, South Africa; Dr. Gogate's Eye Clinic; Department of Ophthalmology, Padmashri D. Y. Patil Medical College, Pimpri, Pune, Maharashtra, India
2 African Vision Research Institute, Durban, South Africa; Brien Holden Vision Institute, Sydney, Australia
3 Independent Biostatistician, Pune, Maharashtra, India
|Date of Web Publication||1-Jul-2015|
Dr. Gogate's Eye Clinic, K-102, Kumar Garima, Tadiwala Road, Pune - 411 001, Maharashtra, India
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Purpose: A systematic review and meta-analysis comparing the safety, efficacy, and expenses related to phacoemulsification versus manual small incision cataract surgery (SICS).
Methods: PubMed, Cochrane, and Scopus databases were searched with key words manual SICS 6/18 and 6/60; astigmatism and endothelial cell loss postoperatively, intra- and post-operative complications, phacoemulsification, and comparison of SICS and phacoemulsification. Non-English language manuscripts and manuscripts not indexed in the three databases were also search for comparison of SICS with phacoemulsification. Data were compared between techniques for postoperative uncorrected and corrected distance visual acuity (UCVA and best corrected visual acuity [BCVA], respectively) better than 6/9, surgical cost and duration of surgery. The Oxford cataract treatment and evaluation team scores were used for grading intraoperative and postoperative complications, uncorrected near vision.
Result: This review analyzed, 11 comparative studies documenting 76,838 eyes that had undergone cataract surgery considered for analysis. UCVA of 6/18 UCVA and 6/18 BCVA were comparable between techniques (P = 0.373 and P = 0.567, respectively). BCVA of 6/9 was comparable between techniques (P = 0.685). UCVA of 6/60 and 6/60 BCVA aided and unaided vision were comparable (P = 0.126 and P = 0.317, respectively). There was no statistical difference in: Endothelial cell loss during surgery (P = 0.298), intraoperative (P = 0.964) complications, and postoperative complications (P = 0.362). The phacoemulsification group had statistically significantly less astigmatism (P = 0.005) and more eyes with UCVA of 6/9 (P = 0.040). UCVA at near was statistically significantly better with SICS due to astigmatism and safer during the learning phase (P = 0.003). The average time for SICS was lower than phacoemulsification and cost <½ of phacoemulsification.
Conclusion: The outcome of this meta-analysis indicated there is no difference between phacoemulsification and SICS for BCVA and UCVA of 6/18 and 6/60. Endothelial cell loss and intraoperative and postoperative complications were similar between procedures. SICS resulted in statistically greater astigmatism and UCVA of 6/9 or worse, however, near UCVA was better.
Keywords: Astigmatism, Manual Small Incision Cataract Surgery, Meta-Analysis, Phacoemulsification, Vision Outcome
|How to cite this article:|
Gogate P, Optom JB, Deshpande S, Naidoo K. Meta-analysis to compare the safety and efficacy of manual small incision cataract surgery and phacoemulsification. Middle East Afr J Ophthalmol 2015;22:362-9
|How to cite this URL:|
Gogate P, Optom JB, Deshpande S, Naidoo K. Meta-analysis to compare the safety and efficacy of manual small incision cataract surgery and phacoemulsification. Middle East Afr J Ophthalmol [serial online] 2015 [cited 2019 Sep 19];22:362-9. Available from: http://www.meajo.org/text.asp?2015/22/3/362/159763
| Introduction|| |
Cataract remains the leading cause of avoidable blindness worldwide.  However, the safest, most effective, and economical technique of cataract surgery remains debatable. , Over the past decade, manual small incision cataract surgery (SICS) has become an established surgical alternative to phacoemulsification. Phacoemulsification is the preferred technique in the developed world and tertiary centers of developing countries. ,,,,, Numerous randomized controlled clinical trials (RCTs) have proved both techniques are safe and effective for rehabilitating the vision of cataract patients. ,,,,, The advantage of both techniques are sutureless, require small incisions, and result in faster visual rehabilitation. Phacoemulsification requires a much smaller incision (3.2 mm) than SICS but the incision size dependent on the type of phacoemulsification machine being used. An ultrasonic probe is used to emulsify the cataractous crystalline lens, and the debris is aspirated with high vacuum. In manual SICS, the entire crystalline lens is removed through a self-sealing scleral tunnel incision (5-7 mm) and a rigid polymethyl methacrylate intraocular lens implanted. A meta-analysis published last year reported mostly comparable results with both techniques with phacoemulsification providing better uncorrected visual acuity (UCVA) due to lower astigmatism.  The results were drawn from the six RCTs, which were selected using the Jaded composite scale.  Although, the study discussed postoperative UCVA and best-corrected visual acuity (BCVA), astigmatism and complications, it did not comprehensively evaluate the complications (during and after surgery), learning curves and surgeon time for SICS and phacoemulsification.
The significant backlog of individuals who are blind due to cataract awaiting surgery has resulted in cataract being the leading cause of avoidable blindness globally, including in Africa.  The reasons for this backlog include lack of access to eye care and lack of resources, specially trained surgeons, to deliver cataract surgery safely, and reliably. We performed a meta-analysis comparing SICS with phacoemulsification using a wider publication base, with an emphasis on safety, learning curves, and resource inputs to get a more holistic view of the two techniques. Comparisons were performed with the safety, reliability, effectiveness, and affordability of the two surgical techniques.
| Methods|| |
This meta-analysis compared phacoemulsification and SICS. Ethics Board Approval was not required because the study involved a review of published manuscripts, each of which had Research Ethics Board Approval. PubMed, Cochrane, and Scopus databases were searched using the keywords manual SICS and phacoemulsification. Non-English language manuscripts and literature were not indexed that compared SICS to phacoemulsification were also reviewed.
Individual data from each study was grouped for the following objectives.
- Uncorrected and BCVA at 6/18 cut-off (< 6/18 vs. ≥6/18)
- Uncorrected and BCVA at 6/9 cut-off (< 6/9 vs. ≥6/9)
- Uncorrected visual acuity 6/60 cut-off (< 6/60 vs. ≥6/60)
- Intraoperative complications
- Postoperative complications
- Endothelial cell loss
- Duration of surgery
- Cost of surgery
- Postoperative UCVA at near.
The cut-off of 6/9 vision was selected because it is the standard acuity required for a driver's license in most developed countries. World Health Organization (WHO) standards classify 6/18 and better vision as normal vision, and 6/60 is considered a severe visual impairment (economic blindness). The legal norm for blindness in the United States and India is 6/60 (< 6/60 in the better eye with available correction). We analyzed UCVA because many patients may not have spectacles or cannot afford a pair of spectacles. Only astigmatism was considered because the postoperative refractive spherical error was addressed by A-scan biometry and proper intraocular lens implantation. The postoperative cylinder depended on the size, site, and type of incision, which differed in the two techniques. The subjective refractive correction was considered for astigmatism.
The Oxford Cataract Treatment and Evaluation Team (OCTET) grading was used to compare the intraoperative and postoperative complications depending on their severity.  The frequency of complications was graded for each technique. The severity of complications was graded, and their effects on final visual acuity were compared. Endothelial cell loss, though not always obvious during surgery, has the ability to affect corneal transparency in the long-term. Endothelial cell loss was compared for both techniques. Intraoperative complications such as posterior capsular rent, vitreous loss, zonular dialysis, and iridodialysis were compared between groups. Postoperative complications were compared between techniques included endophthalmitis, retinal detachment, posterior capsular opacification, postoperative corneal edema that has the potential for corneal decompensation. The complication scores were compared including and excluding high volume settings separately. The duration of each type of surgery and the cost for surgery were compared. This was because surgeon time was a factor in the cost of high volume Asian and African practices where surgeons are scarce. The learning curves were compared between techniques as new surgeons would need to be trained for helping eliminate the cataract backlog.
Statistical analyses were performed using STATA (version 10; StataCorp, College Station, Texas, USA). Randomized control trials or parallel arms (one with phacoemulsification and one SICS) design studies were included in the meta-analysis. Primary outcomes were presented either as binary or continuous variables. Binary data (BCVA and UCVA related) were based on standard cut-offs as explained previously. For binary variables, a pooled odds ratio (OR) with 95% confidence interval (CI) were calculated. For the continuous outcomes, the standardized mean difference (SMD) with 95% CI was calculated. Statistical heterogeneity was tested using the Chi-square and I  statistic. To accommodate the diversity that each study is contributing, or treatment effects that individual studies are estimating; the results using random effects modeling are presented. A random-effects meta-analysis was performed using DerSimonian-Laird method.  Intraoperative and postoperative complication data were analyzed by taking weighted estimates for analysis by assigning OCTET score to each of the complication as its weigh, where data was not available (for certain visual acuity cut-offs or details such as endothelial cell loss or astigmatism), those studies were excluded from the meta-analysis of that particular outcome measure. Surgery time and cost data were obtained from a review manuscript. 
| Results|| |
The literature search resulted in 84 studies, which fulfilled the inclusion criteria. One study each involved comparison of phacoemulsification and SICS with conventional extracapsular cataract surgery. Totally, 38 articles were published in PubMed indexed journals, 30 in other indexed journals, 2 in local journals while one was published in the proceedings of the All India Ophthalmology Society's Annual Conference.  Eleven studies involved a direct comparison between phacoemulsification and SICS. Of these, six were randomized control trials, ,,,,, and three others were direct comparison, one with near vision data, the second comparing subluxated cataracts while the third compared immature cataract surgery with both techniques. ,, A study by Khanna et al. compared the safety and efficacy of both techniques during their learning curves in a large residency and fellowship training program.  It had a large sample size and variety of complications and dominated the forest plots comparing intraoperative and postoperative complications. Hence, it was not included in the meta-analysis but discussed in parallel, especially in view of safety and complications. A study by Haripriya et al. compared SICS and phacoemulsification in a high volume setting.  With the exception of one study,  the surgeons in all others studies were fully trained, experienced cataract surgeons. The total sample size was 76,838 for the complications data from 11 studies. After excluding the Haripriya et al. and Khanna et al. studies, the other 9 studies had a total sample size of 1768 cataract surgeries.
Comparison of best corrected visual acuity at the 6/18 cut-off using phacoemulsification versus the small incision cataract surgery technique
[Figure 1]a presents the comparison of BCVA < 6/18, relatively poor or borderline and poor outcomes with phacoemulsification versus SICS.
|Figure 1: (a) Comparison of best corrected visual acuity at 6/18 cutoff using Phaco vs. SICS Meta Analysis based on data from 7 studies; Event is BCVA < 6/18, OR: odds ratio, OR of Phaco over SICS. (b) Comparison of Unaided corrected visual acuity at 6/18 cutoff using Phaco vs. SICS Meta Analysis based on data from 5 studies; Event is UCVA < 6/18, OR: odds ratio, OR of Phaco over SICS|
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Seven publications included BCVA data on 1229 eyes reported the proportion of patients with BCVA < 6/18 versus BCVA of 6/18 or better postoperatively (around 6 weeks + 2 weeks). Heterogeneity among study resulted was detected to be (I  = 0.0%). Analysis of these data revealed that the difference in the proportion of participants with BCVA 6/18 postoperatively between the phacoemulsification and SICS groups was not significant (OR: 0.73 95% CI: 0.34-1.82) (P = 0.989).
Comparison of uncorrected visual acuity at 6/18 cut-off
[Figure 1]b presents the comparison of UCVA < 6/18 versus UCVA >6/18, relatively poor or borderline and poor outcomes with phacoemulsification versus SICS.
Five publications included UCVA data on 1082 eyes and reported the proportion of patients with UCVA < 6/18 versus UCVA of 6/18 or better postoperatively (around 6 weeks + 2 weeks). Heterogeneity among studies was estimated to be (I 2 = 53.10%). Analysis of the data revealed that the difference in the proportion of participants with UCVA < 6/18 postoperatively between techniques was not statistically significant (OR: 0.81; 95% CI: 0.51-1.29; I 2 = 53.1%, P = 0.373) [Figure 1]b.
Comparison of 6/9 best corrected visual acuity
[Figure 2]a presents the comparison of BCVA >6/9 with phacoemulsification versus SICS. Three publications reported the proportion of patients with BCVA >6/9 versus BCVA of < 6/9 postoperatively (6 weeks + 2 weeks). Random effect modeling was used and analysis of these data indicated no statistical difference in the proportion of participants with postoperative UCVA < 6/9 between techniques (OR: 0.81; 95% CI: 0.3-2.22; P = 0.685) [Figure 2]a.
|Figure 2: (a) Comparison of best corrected visual acuity at 6/9 cutoff using Phaco vs. SICS. (b) Comparison of unaided corrected visual acuity at 6/9 cutoff using Phaco vs. SICS|
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Comparison of uncorrected visual acuity <6/9
[Figure 2]b compares UCVA < 6/9 between techniques. Three publications reported the proportion of patients with UCVA >6/9 vs. UCVA < 6/9 postoperatively (6 weeks + 2 weeks). Random effect modeling was used and data analysis indicated that there was a statistically significant difference between the proportion of participants with postoperative UCVA >6/9 was (OR: 0.71; 95% CI: 0.51-0.98; P = 0.04) [Figure 2]b.
Comparison of best corrected visual acuity and uncorrected visual acuity at 6/60 cut-off
[Figure 3]a compares BCVA < 6/60, a poor outcome with phacoemulsification versus SICS. Two publications presented data on UCVA < 6/60 for 1777 eyes and reported the proportion of patients with BCVA < 6/60 versus BCVA of 6/60 or better postoperatively (around 6 weeks + 2 weeks). Khanna et al. study were included in this analysis. The difference in BCVA < 6/60 postoperatively between techniques was not statistically significant (OR: 0.61; 95% CI: 0.33-1.19; P = 0.126) [Figure 3]a. [Figure 3]b compares aided visual acuity < 6/60, a poor outcome with phacoemulsification versus SICS. There was no statistical difference between techniques (OR: 2.19; 95% CI, 0.46-10.38; P = 0.314) [Figure 3]b.
|Figure 3: (a) Comparison of best corrected visual acuity at 6/60 cutoff using Phaco vs. SICS. (b) Comparison of unaided corrected visual acuity at 6/60 cutoff using Phaco vs. SICS|
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Comparison of astigmatism with both techniques
[Figure 4] compares postoperative astigmatism after phacoemulsification versus SICS. Seven studies evaluated 1303 eyes, comparing surgically induced astigmatism after phacoemulsification and SICS. Phacoemulsification had statistically significantly lower than SICS (SMD = −0.614; 95% CI: −1.05, −0.18; P = 0.005). The smaller incision size in phacoemulsification led to significantly lower astigmatism than SICS.
Comparison of complications with both techniques
Khanna et al. compared outcomes while learning both techniques. Haripriya et al. presented data from a high volume, high-quality cataract surgery practice. Hence, the intraoperative and postoperative complications were analyzed separately, with and without these two manuscripts.
Comparison of intraoperative complications with each technique
[Figure 5] compares of intraoperative complications excluding Khanna et al.  study and Haripriya et al.  study. Six studies that compared intraoperative complication for a total of 1220 eyes were reviewed. There was no difference in intraoperative complications between techniques (P > 0.05).
|Figure 5: (a) Intra-operative complications excluding studies with learning curves and high volume surgery using Phaco vs. SICS technique. (b) Intra-operative complications including high volume setting. (c) Intra-operative complications including studies with learning curves and high volume surgery using Phaco vs. SICS technique|
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Comparison of postoperative complications with both techniques
[Figure 6] compares postoperative complications excluding Khanna et al.  study and Haripriya et al.  study. Using the OCTET scores, there was no difference between the two techniques (P = 0.362).
|Figure 6: (a) Post-operative complications excluding studies with learning curves and high volume surgery using Phaco vs. SICS technique. (b) Post-operative complications including high volume settings but excluding studies with learning curves. (c) Post-operative complications including studies with learning curves and high volume surgery|
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Comparison of endothelial cell loss with both techniques
[Figure 7] compares the change in endothelial cell count after each phacoemulsification and SICS. Two studies compared endothelial cell loss after phacoemulsification and SICS each were similarly weighted in the meta-analysis. The odds ratio was OR 1.00 (−0.29, 2.90). One study  reported higher loss with phacoemulsification and the other study reported no difference, even though sodium hyaluronate and acrylic foldable lenses were used for phacoemulsification and methylcellulose, and PMMA lenses were implanted for patients undergoing SICS in both studies.
Comparison of duration of surgery
The average duration of surgery of each technique is presented in [Table 1].
|Table 1: Average duration of phacoemulsification and manual small incision cataract surgery|
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A meta-analysis could not be performed as the published manuscripts did not report standard deviations for each surgery. All except one of the five publications report much lower average time for SICS than phacoemulsification. ,
The cost of each technique is present in [Table 2]. The details are presented from a review article. ,,,,
Postoperative uncorrected near visual acuity
One prospective comparative study found the 35% of SICS patients had UCVA at near better than N9 compared to 3% of phacoemulsification patients, when the A-scan and IOL power was calculated for emmetropia at a distance.  Near UCVA between N 9 and < N 18 was reported in 46% of SICS patients and 16% of phacoemulsification patients. Near UCVA of N 18 or better was reported in 81% of SICS patients and 19% of phaco patients.  Against-the-rule myopic astigmatism helped more patients achieve better UCVA at near after SICS.
| Discussion|| |
The meta-analysis revealed no differences between phacoemulsification and SICS for BCVA and UCVA at the 6/18 and 6/60 cut-offs and at the BCVA 6/9 cut-off. There was a small difference favoring phacoemulsification for the 6/9 UCVA cut-off (P = 0.04). There were differences between techniques in endothelial cell loss and intraoperative and postoperative complications scores. However, SICS was safer for beginning surgeons (P = 0.03 for postoperative complications).
The smaller incision size during phacoemulsification resulted in statistically lower postoperative astigmatism. However, this did not translate into a clinically significant difference in UCVA. 6/18 is considered to be normal vision by WHO for most tasks and 6/9 is the international driving license standard in many countries. Normal vision (6/18) postoperatively (UCVA and BCVA) was reported in relatively equivalent numbers of SICS and phacoemulsification patients. Similarly, almost equivalent numbers of patients undergoing each technique achieved the global standard for driver's license vision (6/9). In terms of safety, vision < 6/60 was similar between techniques. This finding was after considering manuscripts for white, hard cataracts, and immature cataracts which were not a part of earlier meta-analysis, which was based solely on the RCTs. Hence, despite lower postoperative astigmatism after phacoemulsification the UCVA of these patients was not significantly better. Notably, the increased astigmatism in SICS in one series from Miraj, India was responsible for better UCVA compared to phacoemulsification.  Although the lack of postoperative astigmatism improved distance UCVA in phacoemulsification patients, it was associated with impaired UCVA at near.  The unaided near vision was important even in illiterate, rural communities for needlework, cooking and cleaning, answering mobile phones and differentiating currency, and not just for reading and writing. Hence, astigmatism is an issue in differentiating the two techniques; it does not seem to have much impact on functional vision.
There are some limitations of this study including the drawbacks of the design of each individual study included in this meta-analysis. In addition, most studies had a short follow-up (< 4 months). The longer follow-up would lead to a decrease in astigmatism but perhaps increased posterior capsular opacification. However, to negate some of the drawbacks, we have considered all the series comparing the two techniques, not just RTCs, to make the meta-analysis more wide ranging.
Comparison of complications using OCTET scores indicated no difference in safety between techniques. SICS was also safer during the learning phase for residents and trainees across two large, reputed training programs in India. , Some complications such as nucleus drop was observed in phacoemulsification, while iridodialysis was reported in SICS. Descemet's detachment, a not uncommon occurrence, was not discussed in any of the series that were analyzed. The decrease in the endothelial cell count was comparable between techniques. There was slightly greater decrease associated with phacoemulsification despite the use of high-density viscoelastic devices. SICS had improved the visual outcomes in a large community eye care center. 
Small incision cataract surgery was almost half the cost of phacoemulsification with easier learning curves. The duration of surgery was also lower. Hence, a surgeon using SICS would more productive if there was a backlog of cataract patients.
The current meta-analysis did indicate the similarity of results between phacoemulsification and SICS even after considering white, black, hard, and subluxated cataracts. A similar study from China evaluated only RTCs. Some randomized trials reported better UCVA in the phacoemulsification arm of the study  however, this meta-analysis indicates that the difference is not very significant. This outcome was similar to results from a recent Cochrane review. 
The comparable results in UCVA and BCVA; intraoperative and postoperative complications, endothelial cell loss make SICS an equivalent technique to phacoemulsification. After considering the saving in surgeon time, the easier and safer learning curves and the cost of the procedure, SICS is the most suitable surgery for addressing the backlog of cataract blindness in Africa. A study  from South Africa reported phacoemulsification was more effective. However, the South African study  reported 7% eyes with postoperative visual acuity < 6/60 as compared to the WHO standard of < 5%.  The South African study  also reported astigmatism ranged up to 13 D and average astigmatism of one and half times greater than the published literature. In addition, the surgeons are the South African study  used an 8 mm tunnel for SICS with suture unlike the 5.5-6.5 mm in most series. In addition, 8% patients in the phacoemulsification arm required conversion to SICS. 
The lesser duration of surgery and less need for equipment in SICS means the surgeon would be more productive with a higher turnover in communities where there is large backlog of blindness and trained human resources are scarce, as in many African countries. The more economical cost would mean that the same budget could be used for a greater number of beneficiaries. In a limited resource setting with large number of beneficiaries awaiting cataract surgery/backlog of cataract blind, manual SICS is the technique of choice over phacoemulsification, as in Africa. In any publicly funded programs, it would give the most cost effective results. Only when surgery is self-paid would the small advantage of phacoemulsification for UCVA at a distance be justified. Even in developed countries, SICS can be appropriate for dense cataracts where the posterior capsule cannot be seen, phacodonesis is very hard cataracts (as a high phaco power setting is needed) and for inexperienced surgeons. 
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]
[Table 1], [Table 2]
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