-
The Cochrane Database of Systematic... Dec 2020Refractive errors (conditions in which the eye fails to focus objects accurately on the retina due to defects in the refractive system), are the most common cause of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Refractive errors (conditions in which the eye fails to focus objects accurately on the retina due to defects in the refractive system), are the most common cause of visual impairment. Myopia, hyperopia, and astigmatism are low-order aberrations, usually corrected with spectacles, contact lenses, or conventional refractive surgery. Higher-order aberrations (HOAs) can be quantified with wavefront aberration instruments and corrected using wavefront-guided or wavefront-optimized laser surgery. Wavefront-guided ablations are based on preoperative measurements of HOAs; wavefront-optimized ablations are designed to minimize induction of new HOAs while preserving naturally occurring aberrations. Two wavefront procedures are expected to produce better visual acuity than conventional procedures.
OBJECTIVES
The primary objective was to compare effectiveness and safety of wavefront procedures, laser-assisted in-situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) or laser epithelial keratomileusis (LASEK) versus corresponding conventional procedures, for correcting refractive errors in adults for postoperative uncorrected visual acuity, residual refractive errors, and residual HOAs. The secondary objective was to compare two wavefront procedures.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL, which contains the Cochrane Eyes and Vision Trials Register; 2019, Issue 8); Ovid MEDLINE; Ovid Embase; Latin American and Caribbean Health Sciences (LILACS); the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 6 August 2019. We imposed no restrictions by language or year of publication. We used the Science Citation Index (September 2013) and searched the reference lists of included trials to identify additional relevant trials.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) comparing either wavefront modified with conventional refractive surgery or wavefront-optimized with wavefront-guided refractive surgery in participants aged ⪰ 18 years with refractive errors.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodology.
MAIN RESULTS
We identified 33 RCTs conducted in Asia, Europe and United States, totaling 1499 participants (2797 eyes). Participants had refractive errors ranging from high myopia to low hyperopia. Studies reported at least one of the following review-specific outcomes based on proportions of eyes: with uncorrected visual acuity (UCVA) of 20/20 or better, without loss of one or more lines of best spectacle-corrected visual acuity (BSCVA), within ± 0.50 diopters (D) of target refraction, with HOAs and adverse events. Study characteristics and risk of bias Participants were mostly women, mean age 29 and 53 years, and without previous refractive surgery, ocular pathology or systemic comorbidity. We could not judge risks of bias for most domains of most studies. Most studies in which both eyes of a participant were analyzed failed to account for correlations between two eyes in the analysis and reporting of outcomes. Findings For the primary comparison between wavefront (PRK or LASIK or LASEK) and corresponding conventional procedures, 12-month outcome data were available from only one study of PRK with 70 participants. No evidence of more favorable outcomes of wavefront PRK on proportion of eyes: with UCVA of 20/20 or better (risk ratio [RR] 1.03, 95% confidence interval (CI) 0.86 to 1.24); without loss of one or more lines of BSCVA (RR 0.94, 95% CI 0.81 to 1.09); within ± 0.5 D of target refraction (RR 1.03, 95% CI 0.86 to 1.24); and mean spherical equivalent (mean difference [MD] 0.04, 95% CI -0.11 to 0.18). The evidence for each effect estimate was of low certainty. No study reported HOAs at 12 months. At six months, the findings of two to eight studies showed that overall effect estimates and estimates by subgroup of PRK or LASIK or LASEK were consistent with those for PRK at 12 month, and suggest no difference in all outcomes. The certainty of evidence for each outcome was low. For the comparison between wavefront-optimized and wavefront-guided procedures at 12 months, the overall effect estimates for proportion of eyes: with UCVA of 20/20 or better (RR 1.00, 95% CI 0.99 to 1.02; 5 studies, 618 participants); without loss of one or more lines of BSCVA (RR 0.99, 95% CI 0.96 to 1.02; I = 0%; 5 studies, 622 participants); within ± 0.5 diopters of target refraction (RR 1.02, 95% CI 0.95 to 1.09; I = 33%; 4 studies, 480 participants) and mean HOAs (MD 0.03, 95% CI -0.01 to 0.07; I = 41%; 5 studies, 622 participants) showed no evidence of a difference between the two groups. Owing to substantial heterogeneity, we did not calculate an overall effect estimate for mean spherical equivalent at 12 months, but point estimates consistently suggested no difference between wavefront-optimized PRK versus wavefront-guided PRK. However, wavefront-optimized LASIK compared with wavefront-guided LASIK may improve mean spherical equivalent (MD -0.14 D, 95% CI -0.19 to -0.09; 4 studies, 472 participants). All effect estimates were of low certainty of evidence. At six months, the results were consistent with those at 12 months based on two to six studies. The findings suggest no difference between two wavefront procedures for any of the outcomes assessed, except for the subgroup of wavefront-optimized LASIK which showed probable improvement in mean spherical equivalent (MD -0.12 D, 95% CI -0.19 to -0.05; I = 0%; 3 studies, 280 participants; low certainty of evidence) relative to wavefront-guided LASIK. We found a single study comparing wavefront-guided LASIK versus wavefront-guided PRK at six and 12 months. At both time points, effect estimates consistently supported no difference between two procedures. The certain of evidence was very low for all estimates. Adverse events Significant visual loss or optical side effects that were reported were similar between groups.
AUTHORS' CONCLUSIONS
This review suggests that at 12 months and six months postoperatively, there was no important difference between wavefront versus conventional refractive surgery or between wavefront-optimized versus wavefront-guided surgery in the clinical outcomes analyzed. The low certainty of the cumulative evidence reported to date suggests that further randomized comparisons of these surgical approaches would provide more precise estimates of effects but are unlikely to modify our conclusions. Future trials may elect to focus on participant-reported outcomes such as satisfaction with vision before and after surgery and effects of remaining visual aberrations, in addition to contrast sensitivity and clinical outcomes analyzed in this review.
Topics: Adult; Astigmatism; Corneal Wavefront Aberration; Female; Humans; Hyperopia; Keratectomy, Subepithelial, Laser-Assisted; Keratomileusis, Laser In Situ; Lasers, Excimer; Male; Middle Aged; Myopia; Photorefractive Keratectomy; Randomized Controlled Trials as Topic; Treatment Outcome; Visual Acuity
PubMed: 33336797
DOI: 10.1002/14651858.CD012687.pub2 -
BMC Ophthalmology Dec 2023Sutureless scleral fixed intraocular lens implantation (SF-IOL) has become one of the mainstream schemes in clinical treatment of aphakic eyes because of its advantages,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Sutureless scleral fixed intraocular lens implantation (SF-IOL) has become one of the mainstream schemes in clinical treatment of aphakic eyes because of its advantages, such as avoiding dislocation of intraocular lens or subluxation caused by suture degradation or fracture and significant improvement of postoperative visual acuity. However, a consensus on the relative effectiveness and safety of this operation and other methods is still lacking. This study aimed to compare the efficacy and safety of sutureless SF-IOL with other methods. Aphakia means that the lens leaves the normal position and loses its original function, including absence or complete dislocation and subluxation of the lens which could cause anisometropic amblyopia, strabismus, and loss of binocular function in children and adolescents. For adults, the loss of the lens could lead to high hyperopia and affect vision. Above all this disease can seriously affect the quality of life of patients.
METHODS
Literature about sutureless SF-IOL in PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, China Technical Journal VIP database, and Wanfang database published from 2000 to 2022 was reviewed. The weighted average difference was calculated by RevMan5.3 software for analysis. Two researchers independently selected the study and used the Cochrane collaboration tool to assess the risk of errors. Cochrane bias risk tool was used to evaluate the quality of evidence. This study is registered on PROSPERO (CRD42022363282).
RESULTS
The postoperative IOL-related astigmatism of sutureless SF-IOL was lower than that of suture SF-IOL, and there was statistical difference when we compared the absolute postoperative spherical equivalent after sutureless SF-IOL and suture SF-IOL. Indicating that the degree of refractive error after sutureless SF-IOL was lower. Meanwhile, the operation time of sutureless SF-IOL was shorter than that of suture SF-IOL. The subgroup analysis showed that the absolute postoperative spherical equivalent and astigmatism values in Yamane technique were lower than those in suture SF-IOL.
CONCLUSION
Sutureless SF-IOL has the advantages of stable refraction, short operation time, and less postoperative complications. However, high-quality literature to compare these technologies is lacking. Some long-term follow-up longitudinal prospective studies are needed to confirm the findings.
Topics: Adolescent; Adult; Child; Humans; Aphakia; Astigmatism; Lens Implantation, Intraocular; Lenses, Intraocular; Postoperative Complications; Quality of Life; Retrospective Studies; Sclera; Suture Techniques
PubMed: 38053049
DOI: 10.1186/s12886-023-03223-6 -
PloS One 2019To investigate refractive error development in preterm children with severe retinopathy of prematurity (ROP) treated with anti-vascular endothelial growth factor... (Comparative Study)
Comparative Study Meta-Analysis
Development of refractive error in children treated for retinopathy of prematurity with anti-vascular endothelial growth factor (anti-VEGF) agents: A meta-analysis and systematic review.
OBJECTIVE
To investigate refractive error development in preterm children with severe retinopathy of prematurity (ROP) treated with anti-vascular endothelial growth factor (anti-VEGF) agents and laser photocoagulation.
METHODS
Selection criteria were comparative studies that compared the refractive errors in children, birthweights ≤1500 grams and gestational ages ≤30 weeks, and treatments for Type I ROP with intravitreal bevacizumab (IVB) versus laser photocoagulation. Studies were identified using PubMed, Google Scholar, and published reviews. Meta-analyses were performed on the post-treatment outcomes of spherical equivalent (SEQ), cylindrical power, and prevalence of high myopia. Longitudinal development of refractive error in IVB, or in laser-treated children, or in normal full-term children was visually summarized.
RESULTS
Two randomized controlled trials and 5 non-randomized studies, including a total of 272 eyes treated by IVB and 247 eyes treated by laser, were included in this study. Compared with laser-treated children, IVB-treated children have less myopic refractive error (P<0.001), lower prevalence of high myopia (P<0.05), and less astigmatism (P = 0.02).
CONCLUSIONS
Treatment with IVB is associated with less myopia and astigmatism than laser treatment for infants with severe ROP. Given the complexity of ROP and the variability of dosing, our review supports close monitoring of refractive error outcomes in children treated with IVB.
Topics: Angiogenesis Inhibitors; Bevacizumab; Child, Preschool; Follow-Up Studies; Humans; Incidence; Infant; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Intravitreal Injections; Laser Coagulation; Prevalence; Randomized Controlled Trials as Topic; Ranibizumab; Refractive Errors; Retinopathy of Prematurity; Severity of Illness Index; Treatment Outcome; Vascular Endothelial Growth Factor A
PubMed: 31790445
DOI: 10.1371/journal.pone.0225643 -
Acta Ophthalmologica Sep 2021To evaluate the anti-haze effect and visual outcome after intraoperative mitomycin C (MMC) use during photorefractive keratectomy (PRK) in myopia or myopic astigmatism... (Meta-Analysis)
Meta-Analysis
PURPOSE
To evaluate the anti-haze effect and visual outcome after intraoperative mitomycin C (MMC) use during photorefractive keratectomy (PRK) in myopia or myopic astigmatism patients.
METHODS
We searched in PubMed, EMBASE, Cochrane Library and Google Scholar comprehensively to obtain studies comparing the clinical effects after PRK with and without MMC published until February 2020. Meta-analysis of primary outcome (corneal haze rate) and secondary outcomes [predictability, efficacy, safety and corneal endothelial cell density (ECD)] were conducted. We used trial sequential analysis (TSA) in an effort to collect firm evidence supporting our conclusion.
RESULTS
Of the included 11 randomized controlled trials, five cohort and one case-control studies, 3536 eyes (2232 and 1304 in the MMC and control groups, respectively) were enrolled for meta-analysis. The TSA disclosed strong evidence of decline in corneal haze rate in the MMC group compared with that of the control group. In the subgroup analysis of duration, MMC seemed to reduce corneal haze rate in early-onset and late-onset haze. Predictability of refraction and visual acuity were greater in the MMC groups, not significantly though. The proportion of patients losing at least two lines of best corrected visual acuity postoperatively in the MMC groups was lower than that in the control groups. The corneal postoperative ECD showed no significant difference between the MMC and control groups.
CONCLUSION
Our meta-analysis revealed that MMC is an important anti-haze agent in PRK for reducing both early- and late-onset haze and can also help improving predictability of refraction and subjective postoperative visual acuity.
Topics: Corneal Opacity; Cross-Linking Reagents; Humans; Mitomycin; Myopia; Photorefractive Keratectomy; Postoperative Complications; Refraction, Ocular; Visual Acuity
PubMed: 33326173
DOI: 10.1111/aos.14704 -
The Cochrane Database of Systematic... Dec 2019Cataract is the leading cause of blindness in the world, and clinically significant astigmatism may affect up to approximately 20% of people undergoing cataract surgery.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cataract is the leading cause of blindness in the world, and clinically significant astigmatism may affect up to approximately 20% of people undergoing cataract surgery. Pre-existing astigmatism in people undergoing cataract surgery may be treated, among other techniques, by placing corneal incisions near the limbus (limbal relaxing incisions or LRIs) or by toric intraocular lens (IOLs) specially designed to reduce or treat the effect of corneal astigmatism on unaided visual acuity.
OBJECTIVES
To assess the effects of toric IOLs compared with LRIs in the management of astigmatism during phacoemulsification cataract surgery.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register; 2019, Issue 9); Ovid MEDLINE; Ovid Embase and four other databases. The date of the search was 27 September 2019.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing toric IOLs with LRIs during phacoemulsification cataract surgery. DATA COLLECTION AND ANALYSIS: We used standard methods expected by Cochrane. We graded the certainty of the evidence using GRADE. Our primary outcome was the proportion of participants with postoperative residual refractive astigmatism of less than 0.50 dioptres (D) six months or more after surgery. We also collected data on mean residual refractive astigmatism. Secondary outcomes included: uncorrected distance visual acuity, vision-related quality of life, spectacle independence and adverse effects including postoperative lens rotation requiring re-alignment. To supplement the main systematic review assessing the effects of toric IOLs compared with LRIs in the management of astigmatism during phacoemulsification cataract surgery, we sought to identify economic evaluations on the subject.
MAIN RESULTS
We identified 10 relevant studies including 517 people (626 eyes). These studies took place in China (three studies), UK (three), Brazil (one), India (one), Italy (one) and Spain (one). The median age of participants was 71 years. The level of corneal astigmatism specified in the inclusion criteria of these studies ranged from 0.75 D to 3 D. A variety of toric IOLs were used in these studies, in all but one study, these were monofocal. Studies used three different nomograms to determine the size and placement of the LRI. Two studies did not specify this. None of the studies were at low risk of bias in all domains, but two studies were at low risk of bias in all domains except selective outcome reporting, which was unclear. The remaining studies were at a mixture of low, unclear or high risk of bias. People receiving toric IOLs were probably more likely to achieve a postoperative residual refractive astigmatism of less than 0.5 D six months or more after surgery (risk ratio (RR) 1.40, 95% confidence interval (CI) 1.10 to 1.78; 5 RCTs, 262 eyes). We judged this to be moderate-certainty evidence, downgrading for risk of bias. In the included studies, approximately 500 eyes per 1000 achieved postoperative astigmatism less than 0.5 D in the LRI group compared with 700 per 1000 in the toric IOLs group. There was a small difference in residual astigmatism between the two groups, favouring toric IOLs (mean difference (MD) -0.32 D, 95% CI -0.48 to -0.15 D; 10 RCTs, 620 eyes). Although all studies favoured toric IOLs, the results of individual studies were inconsistent (range of effects -0.02 D to -0.71 D; I² = 89%). We considered this to be low-certainty evidence, downgrading for risk of bias and inconsistency. People receiving a toric IOL probably have a small improvement in visual acuity at six months or more after surgery compared to people receiving LRI, but the difference is small and probably clinically insignificant (MD -0.04 logMAR, 95% CI -0.07 to -0.02; 8 RCTs, 474 eyes; moderate-certainty evidence). Low-certainty evidence from one study of 40 people suggested little difference in vision-related quality of life measured using the Visual Function Index (VF-14) (MD -3.01, 95% CI -8.56 to 2.54). Two studies reported spectacle independence and suggested that people receiving toric IOLs may be more likely to be spectacle independent (RR 1.56, 95% CI 1.14 to 2.15; 100 people; low-certainty evidence). There were no cases of lens rotation requiring surgery (very low-certainty evidence). Five studies (320 eyes) commented on a range of other adverse effects including corneal oedema, endophthalmitis and corneal ectasia. All these studies reported that there were no adverse events with the exception of one study (40 eyes) where one participant in the LRI group had a central de-epithelisation which recovered over 10 days. We found no economic studies that compared toric IOLs with LRIs.
AUTHORS' CONCLUSIONS
Toric IOLs probably provide a higher chance of achieving astigmatism within 0.5 D after cataract surgery compared with LRIs. There may be a small mean difference in postoperative astigmatism, favouring toric IOLs, but this difference is likely to be clinically unimportant. There was no evidence of an important difference in postoperative visual acuity or quality of life between the techniques. Evidence on adverse effects was uncertain. The apparent shortage of relevant economic evaluations indicates that economic evidence regarding the costs and consequence of these two procedures is currently lacking.
Topics: Astigmatism; Humans; Keratoplasty, Penetrating; Lens Implantation, Intraocular; Lenses, Intraocular; Phacoemulsification; Postoperative Complications; Randomized Controlled Trials as Topic; Refraction, Ocular; Visual Acuity
PubMed: 31845757
DOI: 10.1002/14651858.CD012801.pub2 -
The Cochrane Database of Systematic... Apr 2020Laser-assisted in-situ keratomileusis (LASIK) is a surgical procedure that corrects refractive errors. This technique creates a flap of the outermost parts of the cornea... (Meta-Analysis)
Meta-Analysis
Laser-assisted in-situ keratomileusis (LASIK) with a mechanical microkeratome compared to LASIK with a femtosecond laser for LASIK in adults with myopia or myopic astigmatism.
BACKGROUND
Laser-assisted in-situ keratomileusis (LASIK) is a surgical procedure that corrects refractive errors. This technique creates a flap of the outermost parts of the cornea (epithelium, bowman layer, and anterior stroma) to expose the middle part of the cornea (stromal bed) and reshape it with excimer laser using photoablation. The flaps can be created by a mechanical microkeratome or a femtosecond laser.
OBJECTIVES
To compare the effectiveness and safety of mechanical microkeratome versus femtosecond laser in LASIK for adults with myopia.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 2); Ovid MEDLINE; Embase; PubMed; LILACS; ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We used no date or language restrictions. We searched the reference lists of included trials. We searched the electronic databases on 22 February 2019.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) of LASIK with a mechanical microkeratome compared to a femtosecond laser in people aged 18 years or older with more than 0.5 diopters of myopia or myopic astigmatism.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included 16 records from 11 trials enrolling 943 adults (1691 eyes) with spherical or spherocylindrical myopia, who were suitable candidates for LASIK. Five hundred and forty-seven participants (824 eyes) received LASIK with a mechanical microkeratome and 588 participants (867 eyes) with a femtosecond laser. Each trial included between nine and 360 participants. In six trials, the same participants received both interventions. Overall, the trials were at an uncertain risk of bias for most domains. At 12 months, data from one trial (42 eyes) indicates no difference in the mean uncorrected visual acuity (logMAR scale) between LASIK with a mechanical microkeratome and LASIK with a femtosecond laser (mean difference (MD) -0.01, 95% confidence interval (CI) -0.06 to 0.04; low-certainty evidence). Similar findings were observed at 12 months after surgery, regarding participants achieving 0.5 diopters within target refraction (risk ratio (RR) 0.97, 95% CI 0.85 to 1.11; 1 trial, 79 eyes; low-certainty evidence) as well as mean spherical equivalent of the refractive error 12 months after surgery (MD 0.09, 95% CI -0.01 to 0.19; 3 trials, 168 eyes [92 participants]; low-certainty evidence). Based on data from three trials (134 eyes, 66 participants), mechanical microkeratome was associated with lower risk of diffuse lamellar keratitis compared with femtosecond laser (RR 0.27, 95% CI 0.10 to 0.78; low-certainty evidence). Thus, diffuse lamellar keratitis was a more common adverse event with femtosecond laser than with mechanical microkeratome, decreasing from an assumed rate of 209 per 1000 people in the femtosecond laser group to 56 per 1000 people in the mechanical microkeratome group. Data from one trial (183 eyes, 183 participants) indicates that dry eye as an adverse event may be more common with mechanical microkeratome than with femtosecond laser, increasing from an assumed rate of 80 per 1000 people in the femtosecond laser group to 457 per 1000 people in the mechanical microkeratome group (RR 5.74, 95% CI 2.92 to 11.29; low-certainty evidence). There was no evidence of a difference between the two groups for corneal haze (RR 0.33, 95% CI 0.01 to 7.96; 1 trial, 43 eyes) and epithelial ingrowth (RR 1.04, 95% CI 0.11 to 9.42; 2 trials, 102 eyes [50 participants]). The certainty of evidence for both outcomes was very low.
AUTHORS' CONCLUSIONS
Regarding the visual acuity outcomes, there may be no difference between LASIK with mechanical microkeratome and LASIK with femtosecond laser. Dry eye and diffuse lamellar keratitis are likely adverse events with mechanical microkeratome and femtosecond laser, respectively. The evidence is uncertain regarding corneal haze and epithelial ingrowth as adverse events of each intervention. The limited number of outcomes reported in the included trials, some with potentially significant risk of bias, makes it difficult to draw a firm conclusion regarding the effectiveness and safety of the interventions investigated in this review.
Topics: Adult; Astigmatism; Humans; Keratomileusis, Laser In Situ; Myopia; Randomized Controlled Trials as Topic; Visual Acuity
PubMed: 32255519
DOI: 10.1002/14651858.CD012946.pub2