Dataset Information

Hyperopic refractive correction by LASIK, SMILE or lenticule reimplantation in a non-human primate model.

ABSTRACT: Hyperopia is a common refractive error, apparent in 25% of Europeans. Treatments include spectacles, contact lenses, laser interventions and surgery including implantable contact lenses and lens extraction. Laser treatment offers an expedient and reliable means of correcting ametropia. LASIK is well-established however SMILE (small-incision lenticule extraction) or lenticule implantation (derived from myopic laser-correction) are newer options. In this study we compared the outcomes of hyperopic LASIK, SMILE and lenticule re-implantation in a primate model at +2D/+4D treatment. While re-implantation showed the greatest regression, broadly comparable refractive results were seen at 3-months with SMILE and LASIK (<1.4D of intended), but a greater tendency to regression in +2D lenticule reimplantation. Central corneal thickness showed greater variation at +2D treatment, but central thickening during lenticule reimplantation at +4D treatment was seen (-17± 27?m LASIK, -45 ± 18?m SMILE and 28 ± 17?m Re-implantation; p <0.01) with expected paracentral thinning following SMILE. Although in vivo confocal microscopy appeared to show higher reflectivity in all +4D treatment groups, there were minimal and inconsistent changes in inflammatory responses between modalities. SMILE and lenticule re-implantation may represent a safe and viable method for treating hyperopia, but further optimization for lower hyperopic treatments is warranted.

SUBMITTER: Williams GP

PROVIDER: S-EPMC5874005 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Hyperopic refractive correction by LASIK, SMILE or lenticule reimplantation in a non-human primate model.

Williams Geraint P GP Wu Benjamin B Liu Yu Chi YC Teo Ericia E Nyein Chan L CL Peh Gary G Tan Donald T DT Mehta Jodhbir S JS

PloS one 20180328 3

Hyperopia is a common refractive error, apparent in 25% of Europeans. Treatments include spectacles, contact lenses, laser interventions and surgery including implantable contact lenses and lens extraction. Laser treatment offers an expedient and reliable means of correcting ametropia. LASIK is well-established however SMILE (small-incision lenticule extraction) or lenticule implantation (derived from myopic laser-correction) are newer options. In this study we compared the outcomes of hyperopic ...[more]

PMID: 29590157

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Project description:Small incision lenticule extraction or SMILE is a novel form of 'flapless' corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3?months post-operatively.Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21?years old) with myopia (> -3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3?months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21?years old) with myopia (> -3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3?months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye.This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice.Clinicaltrials.gov NCT01216475.

Project description:PurposeThe goal of this study was to compare small incision lenticule extraction (SMILE) with femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for treating myopia.MethodsThe CENTRAL, EMBASE, PubMed databases and a Chinese database (SinoMed) were searched in May of 2016. Twelve studies with 1,076 eyes, which included three randomized controlled trials (RCTs) and nine cohorts, met our inclusion criteria. The overall quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group framework. Data were extracted and analysed at three to six months postoperatively. Primary outcome measures included a loss of one or more lines of best spectacle corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA) of 20/20 or better, mean logMAR UCVA, postoperative mean spherical equivalent (SE) and postoperative refraction within ±1.0 D of the target refraction. Secondary outcome measures included ocular surface disease index (OSDI), tear breakup time (TBUT) and Schirmer's 1 test (S1T) as dry eye parameters, along with corneal sensitivity.ResultsThe overall quality of evidence was considered to be low to very low. Pooled results revealed no significant differences between the two groups with regard to a loss of one or more lines in the BSCVA (OR 1.71; 95% CI: 0.81, 3.63; P = 0.16), UCVA of 20/20 or better (OR 0.71; 95% CI: 0.44, 1.15; P = 0.16), logMAR UCVA (MD 0.00; 95% CI: -0.03, 0.04; P = 0.87), postoperative refractive SE (MD -0.00; 95% CI: -0.05, 0.05; P = 0.97) or postoperative refraction within ±1.0 D of the target refraction (OR 0.78; 95% CI: 0.22, 2.77; P = 0.70) within six months postoperatively. The pooled analysis also indicated that the FS-LASIK group suffered more severely from dry eye symptoms (OSDI; MD -6.68; 95% CI: -11.76, -2.00; P = 0.006) and lower corneal sensitivity (MD 12.40; 95% CI: 10.23, 14.56; P < 0.00001) at six months postoperatively.ConclusionsIn conclusion, both FS-LASIK and SMILE are safe, effective and predictable surgical options for treating myopia. However, dry eye symptoms and loss of corneal sensitivity may occur less frequently after SMILE than after FS-LASIK.

Project description:PurposeTo quantitatively evaluate outcomes after small incision lenticule extraction (SMILE) combined with allogeneic intrastromal lenticule inlay for hyperopia with astigmatism.MethodsIt's a retrospective cohort study. Twenty-four eyes of 15 patients with more than 0.75 diopters (D) of astigmatism in hyperopic eyes were enrolled in this study. The hyperopic eye with astigmatism was first treated with SMILE to correct astigmatism; then a lenticule was extracted from a donor myopic eye and subsequently implanted into the hyperopic eye with astigmatism. Patients were examined preoperatively and 1 day, 1 week, 1,3 months and 1 year after surgery. The main outcome measures were the uncorrected and corrected distance visual acuity (UDVA and CDVA), uncorrected near visual acuity (UNVA), spherical equivalent (SE), corneal topography, anterior segment optical coherence topography (OCT) and ocular response analyzer (ORA) parameters: corneal hysteresis (CH) and corneal resistance factor (CRF). Repeated-measures analyses of variance (ANOVA) and post hoc tests were used to analyze data of different follow-up visits.ResultsThe mean preoperative cylinder was 1.95±1.04(D). The UDVA (from 0.37±0.23 to 0.09±0.09), UNVA (from 0.49±0.21 to 0.08±0.06), SE (from +7.42±3.12 to -0.75±0.79) and astigmatism (+1.95±1.04 to -0.65±0.63) postoperatively were obviously better than those before surgery. Five eyes (26.3%) gained one line of CDVA, and 3 eyes (15.8%) gained two lines of CDVA one year after surgery compared with preoperative levels. The average corneal curvature was changed from (43.19±4.37) D to (49.19±3.87) D one year after surgery. The anterior segment OCT images of corneas with lenticule inlays at each follow-up visit showed that the implanted lenticule was shaped like a crescent in the corneal stroma. The CH and CRF didn't change significantly after surgery (p = 0.189 and p = 0.107respectively).ConclusionsSMILE combined with intrastromal lenticule inlay can be used to correct high hyperopia with astigmatism with good safety, efficacy and reproducibility.

Dataset Information

Hyperopic refractive correction by LASIK, SMILE or lenticule reimplantation in a non-human primate model.

Publications

Hyperopic refractive correction by LASIK, SMILE or lenticule reimplantation in a non-human primate model.

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