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The Cochrane Database of Systematic... Feb 2017Near-sightedness, or myopia, is a condition in which light rays entering the eye along the visual axis focus in front of the retina, resulting in blurred vision. Myopia... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Near-sightedness, or myopia, is a condition in which light rays entering the eye along the visual axis focus in front of the retina, resulting in blurred vision. Myopia can be treated with spectacles, contact lenses, or refractive surgery. Options for refractive surgery include laser-assisted subepithelial keratectomy (LASEK) and laser-assisted in-situ keratomileusis (LASIK). Both procedures utilize a laser to shape the corneal tissue (front of the eye) to correct refractive error, and both create flaps before laser treatment of corneal stromal tissue. Whereas the flap in LASEK is more superficial and epithelial, in LASIK it is thicker and also includes some anterior stromal tissue. LASEK is considered a surface ablation procedure, much like its predecessor, photorefractive keratectomy (PRK). LASEK was developed as an alternative to PRK to address the issue of pain associated with epithelial debridement used for PRK. Assessing the relative benefits and risks/side effects of LASEK and LASIK warrants a systematic review.
OBJECTIVES
To assess the effects of LASEK versus LASIK for correcting myopia.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register (2016, Issue 10); MEDLINE Ovid (1946 to 24 October 2016); Embase.com (1947 to 24 October 2016); PubMed (1948 to 24 October 2016); LILACS (Latin American and Caribbean Health Sciences Literature Database; 1982 to 24 October 2016); the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), last searched 20 June 2014; ClinicalTrials.gov (www.clinicaltrials.gov); searched 24 October 2016; and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 24 October 2016. We did not use any date or language restrictions in the electronic searches for trials.
SELECTION CRITERIA
We considered only randomized controlled trials (RCTs) for the purposes of this review. Eligible RCTs were those in which myopic participants were assigned randomly to receive either LASEK or LASIK in one or both eyes. We also included paired-eye studies in which investigators randomly selected which of the participant's eyes would receive LASEK or LASIK and assigned the other eye to the other procedure. Participants were men or women between the ages of 18 and 60 years with myopia up to 12 diopters (D) and/or myopic astigmatism of severity up to 3 D, who did not have a history of prior refractive surgery.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened all reports and assessed the risk of bias in trials included in this review. We extracted data and summarized findings using risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes. In the absence of clinical and methodological heterogeneity across trials, we used a random-effects model to calculate summary effect estimates. We used a fixed-effect model when including fewer than three trials in a meta-analysis. When clinical, methodological, or statistical heterogeneity was observed across trials, we reported our findings in a narrative synthesis.
MAIN RESULTS
We identified four eligible trials with 538 eyes of 392 participants for the review, but only three trials (154 participants) provided outcome data for analysis. We found no ongoing trials. Two of four trials were from China, one trial was from Turkey, and the location of one trial was not reported. The risk of bias for most domains was unclear due to poor reporting of trial methods; no trial had a protocol or trial registry record. Three trials enrolled participants with mild to moderate myopia (less than -6.50 D); one trial included only participants with severe myopia (more than -6.00 D).The evidence showed uncertainty in whether there is a difference between LASEK and LASIK in uncorrected visual acuity (UCVA) at 12 months, the primary outcome in our review. The RR and 95% confidence interval (CI) at 12 months after surgery was 0.96 (95% CI 0.82 to 1.13) for UCVA of 20/20 or better and 0.90 (95% CI 0.67 to 1.21) for UCVA of 20/40 or better based on data from one trial with 57 eyes (very low-certainty evidence). People receiving LASEK were less likely to achieve a refractive error within 0.5 diopters of the target at 12 months follow-up (RR 0.69, 95% CI 0.48 to 0.99; 57 eyes; very low-certainty evidence). One trial reported mild corneal haze at six months in one eye in the LASEK group and none in the LASIK group (RR 2.11, 95% CI 0.57 to 7.82; 76 eyes; very low-certainty evidence). None of the included trials reported postoperative pain score or loss of visual acuity, spherical equivalent of the refractive error, or quality of life at 12 months.Refractive regression, an adverse event, was reported only in the LASEK group (8 of 37 eyes) compared with none of 39 eyes in the LASIK group in one trial (low-certainty evidence). Other adverse events, such as corneal flap striae and refractive over-correction, were reported only in the LASIK group (5 of 39 eyes) compared with none of 37 eyes in the LASEK group in one trial (low-certainty evidence).
AUTHORS' CONCLUSIONS
Overall, from the available RCTs, there is uncertainty in how LASEK compares with LASIK in achieving better refractive and visual results in mildly to moderately myopic participants. Large, well-designed RCTs would be required to estimate the magnitude of any difference in efficacy or adverse effects between LASEK and LASIK for treating myopia or myopic astigmatism.
Topics: Adult; Female; Humans; Keratectomy, Subepithelial, Laser-Assisted; Keratomileusis, Laser In Situ; Male; Middle Aged; Myopia; Quality of Life; Randomized Controlled Trials as Topic; Visual Acuity
PubMed: 28197998
DOI: 10.1002/14651858.CD011080.pub2 -
Translational Vision Science &... May 2019To evaluate the efficacy of the functional, keratometric, and refractive postoperative parameters of intracorneal ring segment (ICRS) implantation in keratoconus and its... (Review)
Review
PURPOSE
To evaluate the efficacy of the functional, keratometric, and refractive postoperative parameters of intracorneal ring segment (ICRS) implantation in keratoconus and its association with collagen cross-linking (CXL), photorefractive keratectomy (PRK), and intraocular lenses (IOLs).
METHODS
We conducted a systematic review and meta-analysis on case series published between 2007 and 2017.
RESULTS
We included 95 case series with a total of 4560 patients. We included 64 studies of the ICRS procedure, 20 studies of ICRS+CXL, 9 studies of ICRS+CXL+PRK, and 5 studies of ICRS+IOL. We demonstrated an overall improvement of all parameters in all procedures. Cylinder was decreased with an overall effect size (ES) of -1.15 (-1.36 to -0.95; I = 93.7%). Corrected distance visual acuity was improved with an overall ES of 0.89 (0.78 to 1.00; I = 81.9%). Maximal keratometry was decreased with an overall ES of 0.98 (0.85 to 1.11; I = 78.9%). ICRS+IOL is the best procedure to improve spherical equivalent and uncorrected distance visual acuity ( < 0.05) compared with other procedures. ICRSs versus ICRS+CXL are similar in all parameters except for corrected distance visual acuity. ICRS+CXL+PRK is better than ICRS alone in all parameters except for the correction of spherical equivalent.
CONCLUSIONS
Although the quality and strength of the data are questionable, ICRS implantation is an effective strategy to preserve visual function in keratoconic patients. Particularly, ICRS+CXL+PRK could be a low invasive procedure to propose to young keratoconic patients.
TRANSLATIONAL RELEVANCE
To propose an overview of postoperative parameters on each ICRS procedure on keratoconus.
PubMed: 31211003
DOI: 10.1167/tvst.8.3.38 -
Medicine Feb 2023The pregabalin is approved for the management of persistent pain. The aim of this study is to assess the advantages and disadvantages of the use of pregabalin in eye...
BACKGROUND
The pregabalin is approved for the management of persistent pain. The aim of this study is to assess the advantages and disadvantages of the use of pregabalin in eye pain management.
METHODS
The PubMed, Cochrane Library, Embase, and Web of Science databases were searched until January 2022 for randomized controlled trials. Randomized, double-blinded trials comparing pregabalin with placebo in eye pain management were included. The primary outcome was visual analog scale or numerical rating scale at acute (24 hours) and chronic (≥7 days after surgery) timepoints. The secondary outcomes were analgesic medication requirements and pregabalin-related complications (nausea, vomiting, dizziness, and headache). We also compared the effect of pregabalin on dry-eye syndrome.
MAIN RESULTS
Six relevant articles were identified that studied the use of pregabalin as pain relief for photorefractive keratectomy (n = 2), laser epithelial keratomileusis (n = 1), laser-assisted in situ keratomileusis (n = 1), eyelid surgery (n = 1), and dacryocystorhinostomy (n = 1). Pregabalin was associated with a significant reduction in pain scores (95% confidence interval = -0.41 [-0.76--0.06]) 24 hours after surgical procedures. The data were insufficient to draw conclusions regarding dry eye symptoms. Because of the high heterogeneity of outcomes regarding adverse effects, there is no conclusion regarding the safety of pregabalin in eye pain.
CONCLUSIONS
Pregabalin reduced acute eye pain but had no significant effect on long-term analgesia after ophthalmological surgery in adults. It had no effect on dry-eye symptoms after ocular surgery. Further studies on the safety of pregabalin in eye pain management are required to draw solid conclusions.
Topics: Adult; Humans; Pregabalin; Eye Pain; Analgesics; Analgesia; Acute Pain; Pain, Postoperative
PubMed: 36820573
DOI: 10.1097/MD.0000000000032875 -
Ophthalmic Research 2023Phototherapeutic keratectomy (PTK) has been increasingly used to treat severe recurrent corneal erosion syndrome (RCES) patients who do not respond to other treatments.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Phototherapeutic keratectomy (PTK) has been increasingly used to treat severe recurrent corneal erosion syndrome (RCES) patients who do not respond to other treatments. However, the efficacy and complication of each study are currently uncertain due to varying rates.
OBJECTIVES
The objective of this study was to investigate the safety and efficacy of the PTK for recurrent corneal erosions.
METHODS
This article performed a systematic literature research in Cochrane, Embase, PubMed, Scopus, and the Web of Science for the literature on PTK treatment of RCES until December 20, 2022. The extracted data including recurrence rate and the adverse event rate were used for meta-analysis.
RESULTS
The recurrence rate was 18% (95% CI, 13%-24%) (129/700 eyes). Subgroup analysis showed that the RCE recurrence was 17% (95% CI, 9%-24%) after trauma and 22% (95% CI, 11%-32%) in the corneal dystrophy group. Treatment-related adverse events included subepithelial haze, hyperopic shift, and decrease of the best spectacle-corrected visual acuity. In this study, the incidence of these events was 13% (95% CI, 6%-21%), 20% (95% CI, 11%-28%), and 11% (95% CI, 5%-16%), respectively.
CONCLUSIONS
PTK represented a valuable treatment option for patients with recurrent corneal erosions, especially those with traumatic injuries, which had minimal side effects.
Topics: Humans; Lasers, Excimer; Follow-Up Studies; Visual Acuity; Photorefractive Keratectomy; Corneal Dystrophies, Hereditary; Cornea; Corneal Ulcer; Recurrence; Treatment Outcome; Corneal Diseases
PubMed: 37490883
DOI: 10.1159/000533160 -
Eye & Contact Lens Nov 2023This study systematically reviewed the performance of bandage contact lenses (BCL) such as lotrafilcon A, lotrafilcon B, senofilcon A, balafilcon A, and comfilcon A as...
This study systematically reviewed the performance of bandage contact lenses (BCL) such as lotrafilcon A, lotrafilcon B, senofilcon A, balafilcon A, and comfilcon A as postoperative treatment in different ocular surgeries. A systematic search of English and Chinese databases (from inception to December 2021) was conducted for studies reporting the efficacy of BCLs after ocular surgeries. Postoperative symptoms, corneal healing, and visual outcomes were studied. Overall, 38 studies were identified. Bandage contact lens was applied as a postoperative aid in corneal refractive, cataract, and vitrectomy surgeries. Most studies were on photorefractive keratectomy. Reduced postoperative symptoms were observed within 4 hr to 3 days, whereas re-epithelization of the cornea and healing was complete within 3 to 7 days after ocular surgeries except for vitrectomy. In a vitrectomy, greater comfort and improved corneal epithelium were observed on the seventh day after surgery. An improvement in dry eye symptoms was observed at 7 days with considerable benefits observed after 1 month of cataract surgery. These findings indicate that BCLs are effective for improving postoperative symptoms and facilitation of early visual rehabilitation with a wear time of 8 hr to 7 days depending on the type of ocular surgery.
Topics: Humans; Ophthalmology; Bandages, Hydrocolloid; Contact Lenses, Hydrophilic; Photorefractive Keratectomy; Cataract
PubMed: 37816246
DOI: 10.1097/ICL.0000000000001021 -
BMC Ophthalmology Aug 2019The aim of this study was to compare the postoperative corneal biomechanical properties between small incision lenticule extraction (SMILE) and other corneal refractive... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The aim of this study was to compare the postoperative corneal biomechanical properties between small incision lenticule extraction (SMILE) and other corneal refractive surgeries.
METHODS
A systematic review and meta-analysis were conducted. Articles from January 2005, to April 2019, were identified searching PubMed, EMBASE, Web of Science, and International Clinical Trials Registry Platform. Studies that compared SMILE with other corneal refractive surgeries on adult myopia patients and evaluated corneal biomechanics were included. Multiple effect sizes in each study were combined. Random-effects model was conducted in the meta-analysis.
RESULTS
Twenty-two studies were included: 5 randomized controlled trials (RCTs), 9 prospective and 6 retrospective cohort studies, and 2 cross-sectional studies. Using the combined effect of corneal hysteresis (CH) and corneal resistance factor (CRF), which were obtained from ocular response analyzer (ORA), the pooled Hedges' g of SMILE versus femtosecond laser-assisted in situ keratomileusis (FS-LASIK) was 0.41 (95% CI, 0.00 to 0.81; p = 0.049; I = 78%), versus LASIK was 1.31 (95% CI, 0.54 to 2.08; p < 0.001; I = 77%), versus femtosecond lenticule extraction (FLEX) was - 0.01 (95% CI, - 0.31 to 0.30; p = 0.972; I = 20%), and versus the group of photorefractive keratectomy (PRK) and laser-assisted sub-epithelial keratectomy (LASEK) was - 0.26 (95% CI, - 0.67 to 0.16; p = 0.230; I = 54%). The summary score of Corvis ST (CST) after SMILE was comparable to FS-LASIK/LASIK with the pooled Hedges' g = - 0.05 (95% CI, - 0.24 to 0.14; p = 0.612, I = 55%).
CONCLUSIONS
In terms of preserving corneal biomechanical strength after surgeries, SMILE was superior to either FS-LASIK or LASIK, while comparable to FLEX or PRK/LASEK group based on the results from ORA. More studies are needed to apply CST on evaluating corneal biomechanics after refractive surgeries.
Topics: Biomechanical Phenomena; Cornea; Humans; Keratectomy, Subepithelial, Laser-Assisted; Keratomileusis, Laser In Situ; Myopia; Photorefractive Keratectomy; Postoperative Period; Refraction, Ocular; Visual Acuity
PubMed: 31370817
DOI: 10.1186/s12886-019-1165-3 -
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