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Meta-Analysis
. 2016 Jul 8;7(7):CD010735.
doi: 10.1002/14651858.CD010735.pub2.

Laser-assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery

Alexander C Day  1 , Daniel M Gore, Catey Bunce, Jennifer R Evans
Affiliations
Meta-Analysis

Laser-assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery

Alexander C Day et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Cataract is the leading cause of blindness in the world, and cataract surgery is one of the most commonly performed operations in the Western world. Preferred surgical techniques have changed dramatically over the past half century with associated improvements in outcomes and safety. Femtosecond laser platforms that can accurately and reproducibly perform key steps in cataract surgery, including corneal incisions, capsulotomy and lens fragmentation, are now available. The potential advantages of laser-assisted surgery are broad, and include greater safety and better visual outcomes through greater precision and reproducibility.

Objectives: To compare the effectiveness of laser-assisted cataract surgery with standard ultrasound phacoemulsification cataract surgery by gathering evidence on safety from randomised controlled trials (RCTs).

Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 4), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to May 2016), EMBASE (January 1980 to May 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to May 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) and the U.S. Food and Drugs Administration (FDA) website (www.fda.gov). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 10 May 2016.

Selection criteria: We included randomised controlled trials where laser-assisted cataract surgery was compared to standard ultrasound phacoemulsification cataract surgery. We graded the certainty of the evidence using GRADE.

Data collection and analysis: Two review authors independently screened the search results, assessed risk of bias and extracted data using the standard methodological procedures expected by Cochrane. The primary outcome for this review was intraoperative complications in the operated eye, namely anterior capsule and posterior capsule tears. The secondary outcomes were visual acuity (corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA)), refractive outcomes, quality of vision (as measured by any validated visual function score), postoperative complications and cost-effectiveness.

Main results: We included 16 RCTs conducted in Germary, Hungary, Italy, India, China and Brazil that enrolled a total of 1638 eyes of 1245 adult participants. Overall, the studies were at unclear or high risk of bias. In 11 of the studies the authors reported financial links with the manufacturer of the laser platform evaluated in their studies. Five of the studies were within-person (paired-eye) studies with one eye allocated to one procedure and the other eye allocated to the other procedure. These studies were reported ignoring the paired nature of the data.The number of anterior capsule and posterior capsule tears reported in the included studies for both laser cataract surgery and manual phacoemulsification cataract surgery were low. There were four anterior capsule tears and one posterior capsule tear in 1076 eyes reported in 10 studies (2 anterior capsule tears in laser arms, 2 anterior capsule tears and 1 posterior capsule tear in standard phacoemulsification arms). We are very uncertain as to the effect of laser-assisted surgery compared to standard phacoemulsification surgery with respect to these two outcomes. For postoperative cystoid macular oedema and elevated postoperative intraocular pressures, again the evidence was inconclusive (odds ratio (OR) 0.58, 95% confidence interval (CI) 0.20 to 1.68; 957 eyes, 9 studies, low certainty evidence; and OR 0.57, 95% CI 0.11 to 2.86; 903 eyes, 8 studies, low certainty evidence).We found little evidence of any important difference in postoperative visual acuity between laser-assisted and standard phacoemulsification arms. There was a small advantage for laser-assisted cataract surgery at six months in CDVA. However, the mean difference (MD) was -0.03 logMAR (95% CI -0.05 to -0.00; 224 eyes, 3 studies, low certainty evidence) which is equivalent to 1.5 logMAR letters and is therefore, clinically insignificant. No studies reported patient-reported outcome measures such as visual function.There were no data reported on costs or resource use but three studies reported the time taken to do the surgery. There was little evidence of any major difference between the two procedures in this respect (MD 0.1 minutes, 95% CI -0.02 to 0.21; 274 eyes, low certainty evidence).

Authors' conclusions: The evidence from the 16 randomised controlled trials RCTs included in this review could not determine the equivalence or superiority of laser-assisted cataract surgery compared to standard manual phacoemulsification for our chosen outcomes due to the low to very low certainty of the evidence available from these studies. As complications occur rarely, large, adequately powered, well designed, independent RCTs comparing the safety and efficacy of laser-assisted cataract surgery with standard phacoemulsification cataract surgery are needed. Standardised reporting of complications and visual and refractive outcomes for cataract surgery would facilitate future synthesis. Data on patient-reported outcomes and cost-effectiveness are needed. Paired-eye studies should be analysed and reported appropriately.

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Conflict of interest statement

Alex Day is the sub‐Principal Investigator for the ongoing FACT trial (ISRCTN77602616). Catey Bunce is a Co‐Applicant for the ongoing FACT trial (ISRCTN77602616).

Daniel Gore, Jennifer Evans: None to declare.

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figure 3
Figure 3
Risk of bias summary: review authors' judgements about each risk of bias in each included study.
Analysis 1.1
Analysis 1.1
Comparison 1 Laser‐assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery, Outcome 1 Intraoperative complications.
Analysis 1.2
Analysis 1.2
Comparison 1 Laser‐assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery, Outcome 2 Visual acuity.
Analysis 1.3
Analysis 1.3
Comparison 1 Laser‐assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery, Outcome 3 Total duration of procedure.
Analysis 1.4
Analysis 1.4
Comparison 1 Laser‐assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery, Outcome 4 Postoperative complications.
Analysis 1.5
Analysis 1.5
Comparison 1 Laser‐assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery, Outcome 5 Refractive outcomes ‐ mean absolute error.
See this image and copyright information in PMC

References

References to studies included in this review

    1. Conrad‐Hengerer I, Al Juburi M, Schultz T, Hengerer FH, Dick HB. Corneal endothelial cell loss and corneal thickness in conventional compared with femtosecond laser‐assisted cataract surgery: three‐month follow‐up. Journal of Cataract and Refractive Surgery 2013;39(9):1307‐13. - PubMed
    1. Conrad‐Hengerer I, Hengerer FH, Al Juburi M, Schultz T, Dick HB. Femtosecond laser‐induced macular changes and anterior segment inflammation in cataract surgery. Journal of Cataract and Refractive Surgery 2014;30(4):222‐6. - PubMed
    1. Conrad‐Hengerer I, Al Sheikh M, Hengerer FH, Schultz T, Dick HB. Comparison of visual recovery and refractive stability between femtosecond laser‐assisted cataract surgery and standard phacoemulsification: Six‐month follow‐up. Journal of Cataract and Refractive Surgery 2015;41(7):1356‐64. - PubMed
    1. Dick HB, Conrad‐Hengerer I, Schultz T. Intraindividual capsular bag shrinkage comparing standard and laser‐assisted cataract surgery. Journal of Refractive Surgery 2014;30(4):228‐33. - PubMed
    1. Filkorn T, Kovács I, Takács A, Horváth E, Knorz MC, Nagy ZZ. Comparison of IOL power calculation and refractive outcome after laser refractive cataract surgery with a femtosecond laser versus conventional phacoemulsification. Journal of Refractive Surgery 2012;28(8):540‐4. - PubMed

References to studies excluded from this review

    1. Conrad‐Hengerer I, Hengerer FH, Schultz T, Dick HB. Effect of femtosecond laser fragmentation on effective phacoemulsification time in cataract surgery. Journal of Refractive Surgery 2012;28(12):879‐83. - PubMed
    1. Conrad‐Hengerer I, Hengerer FH, Schultz T, Dick HB. Femtosecond laser–assisted cataract surgery in eyes with a small pupil. Journal of Cataract and Refractive Surgery 2013;39(9):1314‐20. - PubMed
    1. Conrad‐Hengerer I, Schultz T, Jones JJ, Hengerer FH, Dick B. Cortex removal after laser cataract surgery and standard phacoemulsification: a critical analysis of 800 consecutive cases. Journal of Refractive Surgery 2014;30(8):516‐20. - PubMed
    1. Ecsedy M, Mihaltz K, Kovacs I, Takacs A, Filkorn T, Nagy ZZ. Effect of femtosecond laser cataract surgery on the macula. Journal of Refractive Surgery 2011;27(10):717‐22. - PubMed
    1. Espaillat A, Pérez O, Potvin R. Clinical outcomes using standard phacoemulsification and femtosecond laser‐assisted surgery with toric intraocular lenses. Clinical Ophthalmology 2016;10:555‐63. - PMC - PubMed

References to ongoing studies

    1. The FACT trial: a randomised comparison of femtosecond laser‐assisted vs. manual phacoemulsification cataract surgery for adults with visually significant cataract. Ongoing study 01/05/2015. - PMC - PubMed
    1. NCT01693211. Prospective evaluation of circularity and diameter of femtosecond laser versus manual anterior capsulotomy in Singapore National Eye Centre. clinicaltrials.gov/ct2/show/NCT01693211 (accessed 27 June 2016).
    1. NCT01769313. A single centre study to analyze cataract surgery following femtosecond laser‐assisted and manual cataract surgery. clinicaltrials.gov/ct2/show/NCT01769313 (accessed 27 June 2016).
    1. NCT01971177. Addressing efficacy and safety of femtosecond‐laser assisted versus manual lens fragmentation procedure. clinicaltrials.gov/ct2/show/NCT01971177 (accessed 27 June 2016).
    1. NCT01982006. Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery (FEMCAT) [Impact médico‐economique de la chirurgie de la cataracte au laser femtoseconde]. clinicaltrials.gov/ct2/show/NCT01982006 (accessed 27 June 2016).

Additional references

    1. Abell RG, Kerr NM, Vote BJ. Toward zero effective phacoemulsification time using femtosecond laser pretreatment. Ophthalmology 2013;120(5):942‐8. - PubMed
    1. Abell RG, Darian‐Smith E, Kan JB, Allen PL, Ewe SY, Vote BJ. Femtosecond laser‐assisted cataract surgery versus standard phacoemulsification cataract surgery: outcomes and safety in more than 4000 cases at a single center. Journal of Cataract and Refractive Surgery 2015;41(1):47‐52. - PubMed
    1. Bali SJ, Hodge C, Lawless M, Roberts TV, Sutton G. Early experience with the femtosecond laser for cataract surgery. Ophthalmology 2012;119(5):891‐9. - PubMed
    1. Chee SP, Yang Y, Ti SE. Clinical outcomes in the first two years of femtosecond laser‐assisted cataract surgery. American Journal of Ophthalmology 2015;159(4):714‐9. - PubMed
    1. Day AC, Gartry DS, Maurino V, Allan BD, Stevens JD. Efficacy of anterior capsulotomy creation in femtosecond laser‐assisted cataract surgery. Journal of Cataract and Refractive Surgery 2014;40(12):2031‐4. - PubMed

References to other published versions of this review

    1. Day Alexander C, Gore Daniel M, Bunce C. Laser assisted versus manual phacoemulsification for lens extraction. Cochrane Database of Systematic Reviews 2013, Issue 9. [DOI: 10.1002/14651858.CD010735] - DOI

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