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Foldable vs rigid lenses after phacoemulsification for cataract surgery: a randomised controlled trial.

ABSTRACT: PURPOSE: To compare the outcomes of phacoemulsification with either a 2.5-mm clear corneal incision and a foldable intraocular lens (IOL) or a 5-mm sclerocorneal tunnel incision and a rigid polymethyl methacrylate (PMMA) IOL. METHODS: In a prospective, randomised clinical trial of phacoemulsification cataract surgery, 1200 patients received either a foldable hydrophilic acrylic IOL through a 2.5-mm corneal incision or an inexpensive rigid PMMA IOL via a 5-mm sclerocorneal tunnel. Intra- and post-operative data and visual acuity at discharge, 6 weeks, and 1 year follow-up were analysed. RESULTS: At 1 year after surgery, 996 (83.0%) patients were followed up with an uncorrected visual acuity of 6/18 or better in 90.3% of the foldable and 94.3% in the rigid IOL group (risk ratio (RR) 0.96, 95% confidence intervals (CI) 0.92-0.99). Poor outcome (best-corrected acuity 6/60 or worse) occurred in 1.0% and 0.4%, respectively (RR 4.28, 95% CI 0.48-38.18). The surgical cost of consumables and overall surgical time were similar in both groups; however, the cost of the foldable IOL was eight times higher than the PMMA IOL. Posterior capsule opacification was more common in the rigid IOL group at 12 months (36.1% vs 23.3%); however, this did not affect post-operative vision. CONCLUSION: In the hands of experienced cataract surgeons, phacoemulsification with implantation of a foldable or a rigid IOL gives excellent results. Using an inexpensive rigid PMMA IOL will make phacoemulsification more affordable for poor patients in low- and middle-income countries.

SUBMITTER: Hennig A

PROVIDER: S-EPMC4017108 | biostudies-other | 2014 May

REPOSITORIES: biostudies-other

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Project description:PurposeTo report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS).DesignMulticenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).ParticipantsSeven hundred eighty-five patients with age-related cataract.MethodsThis trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616.Main outcome measuresWe enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was -0.01 logMAR (-0.05 to 0.03), and mean corrected distance visual acuity difference was -0.01 logMAR (95% confidence interval [CI], -0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome.ConclusionsFemtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.

Project description:PurposeThe aim of this study was to evaluate corneal endothelial cell density and morphology, central corneal thickness, and best visual acuity using ultrasound (US) phacoemulsification or nanosecond laser technique.SettingDepartment of ophthalmology, Nabeul, Tunisia.DesignProspective cohort study.MethodsThis study included eyes with nuclear cataracts with a density grade of 1, 2, 3, or 4 according to LOCS III, divided into two groups; group 1 had conventional US, and group 2 had nanosecond laser. The endothelial cell density (ECD), coefficient of variation (CoV) in cell size, percentage of hexagonal cells, central corneal thickness (CCT) and best visual acuity (VA) were evaluated during 24 months.ResultsSeventy-four eyes had uneventful surgery, 40 in group 1, 34 in group 2. Three procedures in group 2 required conversion to standard phacoemulsification. The mean ECD decreased from 2616.4 ± 194.6 cells/mm2 in group 1 preoperatively to 2088.4 ± 229.9 after 2 years. In group 2, it decreased from 2611.8 ± 186.5 cells/mm2 to 2276.4 ± 163.8 after 2 years. The change was statistically significant in both groups. The decline of the mean ECD in group 2 was significantly less important than in group 1 (p = <10-2). The mean percentage of hexagonal cells was 45.18 ± 4.9 preoperatively and 43.5% ± 6.6 after 2 years in group 1. In group 2, it remained almost stable with 45.6 ± 5.1 and 45.4% ± 6.6 preoperatively and after 2 years, respectively. Preoperatively, the mean CoV was 0.39 ± 0.037 in group 1 and 0.38 ± 0.04 in group 2. After 2 years, it was 0.38 ± 0.04 and 0.37 ± 0.038 in group 1 and group 2, respectively. The changes of the mean CoV and the mean percentage of hexagonal cells were significant in both groups, but the difference between the groups was significant only during the six first months postoperatively. In preoperative, the mean corneal central thickness was 509.7 ± 19.5 in group 1 and 510.3 ± 20.4 in group 2. In both groups, the mean corneal thickness increased on D1 postoperatively to 550.9 in group 1, and 528.2 in group 2. The mean corneal thickness decreased more rapidly after 1 week in group 2, to find the initial values. Visual acuity improved from 0.76 Log Mar ± 0.5 at enrolment to 0.45 Log Mar ± 0.2, and 0.033 Log Mar ± 0.086 in group 1 at 1 day post-operative and after 24 months, respectively and from 0.58 Log Mar ± 0.28 to 0.2 Log Mar ± 0.09 and 0.035 Log Mar ± 0.083, respectively in group 2. There was no significant difference in VA at each follow-up between groups except for day 1.ConclusionOur study showed lower corneal tissue trauma, and lower endothelial cell loss in the laser cataract surgery compared to phacoemulsification.Clinical trial registration: (https://classic.clinicaltrials.gov/ct2/show/NCT05886283), identifier NCT05886283.

Project description:Purpose: To compare 1-year clinical outcomes, phacoemulsification energy, aqueous profiles, and patient-reported outcomes of low-energy femtosecond laser-assisted cataract surgery (FLACS) vs. conventional phacoemulsification. Methods: The study is a randomized controlled trial (RCT) with paired-eye design. Eighty-five patients were randomized to receive FLACS (Ziemer LDV Z8) in one eye and conventional phacoemulsification in the fellow eye. Clinical data including phacoemulsification energy parameters (cumulative dissipated energy, phacoemulsification power, and phacoemulsification time), uncorrected and corrected distance visual acuities (UCDVA and BCDVA), manifest refraction spherical equivalent (MRSE), central corneal thickness (CCT), endothelial cell count (ECC), anterior chamber flare, and post-operative complications were obtained for 1 year. Aqueous humor was collected for the analysis of prostaglandin (PGE)2, cytokines and chemokines concentrations. Patients' reported-outcomes on surgical experiences were evaluated using an in-house questionnaire. Results: Compared to conventional phacoemulsification, the low-energy assisted FLACS group had significantly less ECC reduction at 3 months (1.5 ± 0.3% vs. 7.0 ± 2.4%; P < 0.01) and 1 year (8.2 ± 2.8% vs. 11.2 ± 3.6%; P = 0.03). There were no significant differences in the phacoemulsification energy parameters, UCDVA, BCDVA, MRSE, CCT, occurrence of post-operative complications between the 2 groups throughout post-operative 1 year. Patients' subjective surgical experiences, including the surgical duration and perceived inconvenience, were comparable between the 2 groups. FLACS resulted in significantly higher aqueous PGE2 (P < 0.01), interleukin (IL)-6 (P = 0.03), IL-8 (P = 0.03), and interferon (IFN)-γ (P = 0.04) concentrations and greater anterior chamber flare at 1 day (P = 0.02). Conclusions: Our RCT presented 1-year longitudinal clinical and laboratory data. The long-term ECC result was more favorable in low-energy FLACS. The rest of the intraoperative and post-operative outcomes, as well as patient-reported outcomes, were comparable between these two procedures.

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Foldable vs rigid lenses after phacoemulsification for cataract surgery: a randomised controlled trial.

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