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JAMA Ophthalmology Jun 2023During phacoemulsification, incision leakage and the subsequent anterior chamber collapse often occur after the withdrawal of the handpiece, which cannot be prevented by... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
During phacoemulsification, incision leakage and the subsequent anterior chamber collapse often occur after the withdrawal of the handpiece, which cannot be prevented by current sealing techniques. A new technique called swab pressing is proposed here to apply pressure with a cotton swab to seal the incision immediately, but efficacy remains unknown.
OBJECTIVE
To determine if swab pressing is noninferior to stromal hydration, the current practice, in sealing incisions in phacoemulsification for age-related cataract.
DESIGN, SETTING, AND PARTICIPANTS
This noninferiority randomized controlled clinical trial was conducted between February 2022 and September 2022 at the Zhongshan Ophthalmic Center, Guangzhou, China. Patients aged 60 to 90 years with age-related cataract were enrolled.
INTERVENTIONS
Participants were randomly assigned (1:1) to receive swab pressing or stromal hydration. All surgeries were performed by a single experienced surgeon who was unmasked to the assignment.
MAIN OUTCOMES AND MEASURES
The proportion of closed clear corneal incisions evaluated using intraoperative optical coherence tomography.
RESULTS
A total of 126 eyes of 126 participants were randomized into the swab pressing group (63 [50%]) and stromal hydration group (63 [50%]). The mean (SD) age of participants was 69.2 (6.14) years and 70.1 (7.67) years in the pressing and stromal hydration groups, respectively. A total of 39 participants (61.9%) in the pressing group and 35 (55.6%) in the modified group were female. The proportion of closed incisions was 96.8% (61 of 63) in the swab pressing group and 93.7% (59 of 63) in the stromal hydration group. Noninferiority was met, as the lower 95% CI of -5.83 percentage points was greater than the prescribed noninferiority margin of -6.60 percentage points (difference, 3.17 percentage points; 95% CI, -5.83 to 12.18 percentage points). The rate of anterior chamber collapse (pressing: 0 of 63 vs stromal hydration: 35 of 63 [55.6%]; P < .001) was lower in the swab pressing group. There were no differences between the 2 groups in the proportion of closed incisions and central anterior chamber depth at postoperative hour 1 and day 1.
CONCLUSIONS AND RELEVANCE
In this study, swab pressing was noninferior to stromal hydration in sealing clear corneal incisions in phacoemulsification for age-related cataract. While this trial involved only 1 surgeon who was not masked to the interventions, the results suggest that swab pressing is feasible and further investigations would be warranted to determine if it prevents the intraoperative transient collapse of anterior chamber or affects visual acuity outcomes.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT05242653.
Topics: Humans; Female; Male; Phacoemulsification; Cataract Extraction; Anterior Chamber; Lens Implantation, Intraocular; Cataract; Cornea
PubMed: 37166786
DOI: 10.1001/jamaophthalmol.2023.1491 -
PloS One 2023This meta-analysis aims to compare corneal injuries and function after femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery... (Meta-Analysis)
Meta-Analysis
This meta-analysis aims to compare corneal injuries and function after femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS). A comprehensive literature search of PubMed, EMBASE, and the Cochrane Controlled Trials Register was conducted to identify randomized controlled trials (RCT) and high-quality prospective comparative cohort studies comparing FLACS with CPS. Endothelial cell loss percentage (ECL%), central corneal thickness (CCT), endothelial cell density (ECD), endothelial cell loss (ECL), percentage of the hexagonal cell (6A), and coefficient of variance (CoV) were used as an indicator of corneal injury and function. Totally 42 trials (23 RCTs and 19 prospective cohort studies), including 3916 eyes, underwent FLACS, and a total of 3736 eyes underwent CPS. ECL% is significantly lower in the FLACS group at 1-3 days (P = 0.005), 1 week (P = 0.004), 1 month (P<0.0001), 3 months (P = 0.001), and 6 months (P = 0.004) after surgery compared to CPS. ECD and ECL appeared no statistically significant difference between the two groups, except for the significant reduction of ECD at 3 months in the CPS group (P = 0.002). CCT was significantly lower in the FLACS group at 1 week (P = 0.05) and 1 month (P = 0.002) early postoperatively. While at 1-3 days (P = 0.50), 3 months (P = 0.18), and 6 months (P = 0.11), there was no difference between the FLACS group and the CPS group. No significant difference was found in the percentage of hexagonal cells and the coefficient of variance. FLACS, compared with CPS, reduces corneal injury in the early postoperative period. Corneal edema recovered faster in the FLACS group in the early postoperative period. In addition, FLACS may be a better option for patients with corneal dysfunction.
Topics: Humans; Phacoemulsification; Laser Therapy; Cataract Extraction; Lasers; Corneal Injuries; Cataract
PubMed: 37058458
DOI: 10.1371/journal.pone.0284181 -
International Ophthalmology Jul 2022To evaluate the outcomes and complications of simultaneous silicon oil removal (SOR) and phacoemulsification and intra ocular lens implantation.
PURPOSE
To evaluate the outcomes and complications of simultaneous silicon oil removal (SOR) and phacoemulsification and intra ocular lens implantation.
METHODS
In this retrospective non-comparative case series, the visual, refractive and anatomical outcomes of patients who underwent combined phacoemulsification/silicone oil removal (5700 centistokes) surgery between 2017 and 2019 in a single center were evaluated.
RESULTS
Forty-four eyes of 44 patients (eighteen males) were included. The mean age of the patients was 51.45 ± 11.59 years. The primary pathology was tractional retinal detachment (TRD) secondary to diabetic retinopathy in 36 eyes and rhegmatogenous retinal detachment (RRD) in 8 eyes. The median time period between silicone oil tamponade and removal was 9 months. There was no statistically significant difference between best corrected visual acuity (-0.14 ± 0.69 LogMAR, p= 0.19) and intraocular pressure (p= 0.26) before and after the surgery. Mean post-operative spherical equivalent (SE) at last visit was 0.36 ± 1.64 which was different from the target refraction (- 0.5D). After cataract/SOR surgery, one eye (2.3%) developed retinal re-detachment in RRD patient. Vitreous hemorrhage occurred in nine eyes (20.5%) which all had TRD as the primary pathology.
CONCLUSION
Combined phacoemulsification, silicone oil and IOL implantation removal surgery seems to be a safe and useful procedure with high success rate and acceptable visual, refractive and anatomical outcomes.
Topics: Adult; Humans; Lens Implantation, Intraocular; Male; Middle Aged; Phacoemulsification; Retinal Detachment; Retrospective Studies; Silicone Oils; Visual Acuity; Vitrectomy
PubMed: 35674997
DOI: 10.1007/s10792-022-02227-3 -
Journal of Glaucoma Sep 2023Compared with phacoemulsification and microstent alone, we observed that phacoemulsification with combined microstent and canaloplasty resulted in a significantly...
PRCIS
Compared with phacoemulsification and microstent alone, we observed that phacoemulsification with combined microstent and canaloplasty resulted in a significantly greater reduction in glaucoma medications while maintaining similar rates of intraocular pressure reduction and low complications.
PURPOSE
The purpose of this study was to compare the outcomes of phacoemulsification combined with Hydrus Microstent (Alcon Inc.) implantation alone or in combination with canaloplasty (OMNI Surgical System, Sight Sciences Inc.).
MATERIALS AND METHODS
Retrospective study of mild-to-moderate primary open angle glaucoma patients who underwent phacoemulsification with microstent alone (42 eyes of 42 patients) or in combination with canaloplasty (canaloplasty-microstent, 32 eyes of 32 patients). The mean number of ocular hypotensive medications and intraocular pressure were assessed preoperatively and postoperatively at 1 week and at 1, 3, and 6 months. Complications and secondary surgical interventions were recorded. Outcomes measures included the percentage of unmedicated eyes and surgical success at 6 months. Surgical success was defined as reaching the target intraocular pressure without medications or secondary surgical interventions.
RESULTS
Mean intraocular pressure at 6 months was 14.1±3.5 mm Hg (13% reduction) after microstent alone and 13.6±3.1 mm Hg (17% reduction) after canaloplasty-microstent. Mean medications at 6 months were 0.57±0.9 (67% reduction) after microstent alone and 0.16±0.4 (88% reduction) after canaloplasty-microstent ( P< 0.05). At 6 months, 64.3% of microstent alone and 87.3% of canaloplasty-microstent were off all medications ( P =0.02). Success probabilities at 6 months were 44.5% for microstent alone and 70.0% for canaloplasty-microstent ( P =0.04). No secondary surgical interventions occurred in either group.
CONCLUSIONS
Microstent combined with canaloplasty resulted in a significantly higher rate of medication-free status compared with microstent alone through 6 months.
Topics: Humans; Intraocular Pressure; Glaucoma, Open-Angle; Retrospective Studies; Phacoemulsification; Limbus Corneae; Cataract
PubMed: 37310992
DOI: 10.1097/IJG.0000000000002245 -
American Journal of Ophthalmology Aug 2023To report 5-year postoperative safety data of iStent inject, including overall stability, endothelial cell density (ECD), and endothelial cell loss (ECL) in patients... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
To report 5-year postoperative safety data of iStent inject, including overall stability, endothelial cell density (ECD), and endothelial cell loss (ECL) in patients with mild-to-moderate primary open-angle glaucoma (POAG).
DESIGN
5-year follow-up safety study of the prospective, randomized, single-masked, concurrently controlled, multicenter iStent inject pivotal trial.
METHODS
In this 5-year follow-up safety study of the 2-year iStent inject pivotal randomized controlled trial, patients receiving iStent inject placement and phacoemulsification or phacoemulsification alone were studied for the incidence of clinically relevant complications associated with iStent inject placement and stability. Corneal endothelial endpoints were mean change in ECD from screening and proportion of patients with >30% ECL from screening, from analysis of central specular endothelial images by a central image analysis reading center at several time points through 60 months postoperatively.
RESULTS
Of the 505 original randomized patients, 227 elected to participate (iStent inject and phacoemulsification group, n = 178; phacoemulsification-alone control group, n = 49). No specific device-related adverse events or complications were reported through month 60. No significant differences were observed in mean ECD, mean percentage change in ECD, or proportion of eyes with >30% ECL between the iStent inject and control groups at any time point; mean percentage decrease in ECD at 60 months was 14.3% ± 13.4% in the iStent inject group and 14.8% ± 10.3% in the control group (P = .8112). The annualized rate of ECD change from 3 to 60 months was neither clinically nor statistically significant between groups.
CONCLUSIONS
Implantation of iStent inject during phacoemulsification in patients with mild-to-moderate POAG did not produce any device-related complications or ECD safety concerns compared to phacoemulsification alone through 60 months.
Topics: Humans; Glaucoma, Open-Angle; Intraocular Pressure; Prospective Studies; Cataract Extraction; Phacoemulsification; Endothelium, Corneal; Stents
PubMed: 36868339
DOI: 10.1016/j.ajo.2023.02.014 -
Indian Journal of Ophthalmology Jan 2020
Topics: Aged; Cataract; Humans; Lens, Crystalline; Male; Phacoemulsification; Slit Lamp Microscopy
PubMed: 31856525
DOI: 10.4103/ijo.IJO_1404_19 -
Indian Journal of Ophthalmology Jan 2020
Topics: Equipment Failure; Humans; Intraoperative Complications; Male; Microscopy, Electron; Middle Aged; Phacoemulsification; Visual Acuity
PubMed: 31856507
DOI: 10.4103/ijo.IJO_419_19 -
European Journal of Ophthalmology Jan 2023To compare and evaluate the results of phacoemulsification surgery involving and not involving an ophthalmic-viscosurgical-device (OVD). (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
To compare and evaluate the results of phacoemulsification surgery involving and not involving an ophthalmic-viscosurgical-device (OVD).
METHODS
A prospective, randomized controlled trial included 60 eyes of 60 patients scheduled to receive phacoemulsification surgery. In order of presentation, patients were randomized into two groups to undergo different surgical techniques: the OVD-free group ( = 30) and the OVD group ( = 30). Each patient's operating time, total ultrasonography (U/S) time, cumulative dissipated energy (CDE), aspiration time, and volume of balanced salt solution (BSS) aspirated were recorded. At 1 day, 1 week, and 1 and 3 months postoperation, measurements of endothelial cell density (ECD) and intraocular pressure (IOP), were taken and compared between the groups.
RESULTS
Total U/S time ( 567) and CDE ( 168) were similar between the groups. In the OVD group, operating time ( 011), aspiration time ( 001), and volume of BSS aspirated ( 001) were greater than in the OVD-free group. The change in ECD between the groups was not statistically significant at all visits ( 433, = 147, = .379, = .534; respectively). Although IOP increased in the OVD group at 1 day postoperation ( 001), no difference emerged between the groups at 3 months postoperation ( 121).
CONCLUSION
Phacoemulsification surgery without an OVD took less time than with the OVD and caused no significant loss in ECD. Surgeons concerned about elevated IOP following cataract surgery should apply the OVD-free method.
Topics: Humans; Phacoemulsification; Lens Implantation, Intraocular; Prospective Studies; Cataract Extraction; Cataract
PubMed: 35895295
DOI: 10.1177/11206721221116701 -
American Journal of Ophthalmology May 2020To investigate the frequency of transient (1 month) and persistent (at least 6 months) postoperative ptosis following clear corneal sutureless phacoemulsification and...
PURPOSE
To investigate the frequency of transient (1 month) and persistent (at least 6 months) postoperative ptosis following clear corneal sutureless phacoemulsification and to analyze the factors affecting them.
DESIGN
Cohort study.
METHODS
Patients who underwent phacoemulsification cataract surgery from October 2016 to June 2018 in a tertiary center were enrolled. Margin reflex distance 1 (MRD1), MRD2, and levator function were measured and facial photography was taken before, 1 month, and at least 6 months after the surgery. Clinical ptosis was defined as any postoperative drop of MRD1 and clinically significant ptosis as MRD1 drop of ≥2 mm. Photo-based ptosis was assessed by a masked oculofacial plastic surgeon at the end of the study.
RESULTS
A total of 234 patients (313 eyelids) were included. The majority of surgeries were performed by senior residents (65.5%, 205/313) and under topical anesthesia (78.0%, 244/313). Persistent clinical, clinically significant, and photo-based ptosis were 25.4% (71/279), 3.2% (9/279), and 3.3% (9/276). Eyelids with persistent postoperative ptosis showed a significantly (P = .03) lower preoperative levator function (13.9 vs 15.8 mm). No other factor was significantly different between the eyelids with and without postoperative ptosis.
CONCLUSION
Persistent clinically significant ptosis was observed in more than 3% of patients undergoing clear corneal sutureless phacoemulsification cataract surgery. It should be counseled preoperatively. Lower preoperative levator function was significantly associated with a higher frequency of postoperative ptosis. Duration of surgery, level of surgeons, and other variables did not have any significant effect on the frequency of postoperative ptosis.
Topics: Blepharoptosis; Eyelids; Female; Humans; Internship and Residency; Lens Implantation, Intraocular; Male; Middle Aged; Operative Time; Ophthalmology; Phacoemulsification; Photography; Postoperative Complications; ROC Curve; Retrospective Studies; Tertiary Care Centers
PubMed: 31926884
DOI: 10.1016/j.ajo.2019.12.023 -
[Zhonghua Yan Ke Za Zhi] Chinese... Jul 2022To investigate the effect of phacoemulsification on the Berger space (BS). A prospective cohort study. Patients with cataract who underwent phacoemulsification and...
To investigate the effect of phacoemulsification on the Berger space (BS). A prospective cohort study. Patients with cataract who underwent phacoemulsification and intraocular lens implantation in the Department of Ophthalmology, Affiliated Hospital of Nantong University from May 2021 to October 2021 were enrolled. The BS was observed by slit-lamp microscopy and anterior segment optical coherence tomography (AS-OCT) before and 1 month after operation. Intraoperative optical coherence tomography with a 25G optical fiber was performed to observe the BS. The number of eyes with the BS and materials in the BS (MIB) detected perioperatively was counted, and the width of the BS was measured. Statistical analysis was carried out by the Chi-square test, generalized estimating equations, Mann-Whitney test and binary logistic regression analysis. A total of 119 patients (119 eyes) were included [44 males, 75 females; mean age, (65±12) years]. Preoperatively, the BS was identified in only 4 eyes (3.4%), and no MIB was found. Intraoperatively, the BS was identified in 47 eyes (39.5%), and the MIB was observed in 20 eyes (16.8%). At one month postoperatively, the BS was identified in 33 eyes (27.7%), of which 16 eyes (13.4%) still had MIB. There were significant differences in the detection rates of the BS and MIB between intraoperative and preoperative groups (both <0.001). The difference in the detection rate of the BS postoperatively compared to intraoperatively was statistically significant (=0.001), while the difference in the detection rate of MIB was not statistically significant (>0.05). The intraoperative and postoperative width of the BS [ (, )] was 160.3 (61.6, 273.1) μm and 106.8 (0, 259.4) μm, respectively, and the difference was statistically significant (=-2.28, =0.023). In addition, the detection rate of the BS and MIB in patients with a high risk of zonular fiber weakness [60.7% (17/28) and 42.9% (12/28)] was significantly higher than that in patients without this risk factor [33.0% (30/91) and 8.8% (8/91)] (²=6.90, =0.009; <0.001). In the multivariable model, weakness of zonular fibers (=0.214, 95%: 0.081 to 0.561) and higher cumulative dissipated energy (=1.255, 95% 1.047 to 1.504) were the main risk factors for structural changes of the BS intraoperatively. Phacoemulsification can damage the normal anatomical structure of the BS, resulting in intraoperative entrance of fluid and particulates to the BS.
Topics: Aged; Cataract; Female; Humans; Lens Implantation, Intraocular; Male; Middle Aged; Phacoemulsification; Prospective Studies; Tomography, Optical Coherence
PubMed: 35796123
DOI: 10.3760/cma.j.cn112142-20220113-00013