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Objectives To investigate the effect of adjunct micro-interventional pre-treatment for nucleus disassembly on the surgical efficiency of non-cavitating lensectomy during cataract surgery. Methods and analysis 12 surgeons performed 512 consecutive cataract extractions using a sonic cavitation-free lensectomy with or without adjunct pre-treatment for nucleus disassembly. There were 2 interventional arms including (1) lensectomy without adjunct pre-treatment and (2) lensectomy with micro-interventional miLOOP pre-treatment. Results Successful lensectomy was achieved in all eyes using cavitation-free sonic lensectomy. Average baseline cataract density was 2.28 and 2.39 in the three groups, respectively. Compared to no pre-treatment, nucleus evacuation time was 24% (p = < 0.001) faster with micro-interventional nucleus disassembly. Irrigation/aspiration (I/A) time was 14% faster with the micro-interventional pre-treatment (p = < 0.001). Irrigation fluid use was 24% less with micro-interventional. There was a low rate of capsular tear of 1 case across 512 cases with no other unanticipated complications. Conclusion Micro-interventional pre-treatment for nucleus disassembly was associated with improved lensectomy time and fluidic efficiency compared to no pre-treatment. Non-cavitating lensectomy with the miCOR lens pen achieved effective fragmentation and extraction in all grades of cataract.

AimTo assess the safety and efficacy of microinterventional endocapsular nuclear fragmentation in moderate to severe cataracts.MethodsThis was a prospective single-masked multisurgeon interventional randomised controlled trial (ClinicalTrials.gov NCT02843594) where 101 eyes of 101 subjects with grade 3‒4+ nuclear cataracts were randomised to torsional phacoemulsification alone (controls) or torsional phacoemulsification with adjunctive endocapsular nuclear fragmentation using a manual microinterventional nitinol filament loop device (miLOOP group). Outcome measures were phacoemulsification efficiency as measured by ultrasound energy (cumulative dispersed energy (CDE) units) and fluidics requirements (total irrigation fluid used) as well as incidence of intraoperative and postoperative complications.ResultsOnly high-grade advanced cataracts were enrolled with more than 85% of eyes with baseline best corrected visual acuity (BCVA) of 20/200 or worse in either group. Mean CDE was 53% higher in controls (32.8±24.9 vs 21.4±13.1 with miLOOP assistance) (p=0.004). Endothelial cell loss after surgery was low and similar between groups (7‒8%, p=0.561) One-month BCVA averaged 20/27 Snellen in miLOOP eyes and 20/24 in controls. No direct complications were caused by the miLOOP. In two cases, capsular tears occurred during IOL implantation and in all remaining cases during phacoemulsification, with none occurring during the miLOOP nucleus disassembly part of the procedure.ConclusionsMicrointerventional endocapsular fragmentation with the manual, disposable miLOOP device achieved consistent, ultrasound-free, full-thickness nucleus disassembly and significantly improved overall phaco efficiency in advanced cataracts.Trial registration numberNCT02843594

Objective To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). Results Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2–7.4, 6.5–7.8, and 6.1–6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group. Conclusions The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma. Clinicaltrials.gov Identifier NCT02250651.

Purpose A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug delivery system designed to provide uninterrupted sustained intraocular pressure (IOP)-lowering therapy, thereby reducing patient treatment burden and improving adherence with IOP-lowering medication. Methods Patients with open-angle glaucoma or ocular hypertension were administered a fast-eluting implant (FE implant, n = 51) and received twice-daily (BID) placebo eye drops, a slow-eluting (SE implant, n = 54) and received BID placebo eye drops, or underwent a sham surgical procedure and received BID timolol 0.5% ( n = 49). IOP was measured at baseline, day 1–2, day 10, week 4, week 6, month 3, and every 3 months thereafter through 36 months. Efficacy was evaluated by mean change from 8:00 AM unmedicated baseline IOP through month 36, and the percentage of patients receiving the same or fewer topical IOP-lowering medications as at screening (pre-study). Safety was evaluated by adverse events and ophthalmic parameters. Results Clinically and statistically relevant IOP-lowering treatment effects were observed through month 36 after a single administration of the travoprost implant compared with BID timolol with mean IOP reductions ranging from 7.6 to 8.8 mmHg for the FE implant group, from 7.3 to 8.0 mmHg for the SE implant group, and from 7.3 to 7.9 for the timolol group at the 8:00 AM timepoint ( P < 0.0001 for all treatment groups at all visits). At months 12, 24, and 36, a greater percentage of FE and SE implant patients versus timolol patients were well controlled on the same or fewer topical IOP-lowering medications compared with screening with 63 and 69% for the FE and SE implants groups, respectively, versus 45% for the timolol group at month 36. The safety profile of the implant was favorable; there were no dislodgements, no explantations, no adverse events of conjunctival hyperemia or periorbital fat atrophy, no discontinuations due to study eye adverse events, nor any serious adverse events in the study eye. Comparable changes from baseline in corneal endothelial cell counts were observed in the three treatment groups over the 36 months. Conclusion The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile. The travoprost intraocular implant promises to be a meaningful addition to the interventional glaucoma armamentarium by addressing the key shortcomings of topical IOP-lowering medications, including low adherence and topical side effects while controlling IOP for up to 36 months. Trial Registry ClinicalTrials.gov identifier NCT02754596 registered 28 April 2016.

When getting started with multifocal intraocular lenses (IOL), it is just as important to choose the right patient as it is which type of multifocal. Many surgeons start out their multifocal careers in disappointment by choosing a medical outlier for their first patient. Your multifocal patients should be some of your happiest patients, because you are \"cherry picking\" them from the start.

The presence of any pathology that causes a loss of reception or transmission of light will cause advanced technology lenses to fail catastrophically, resulting in a suboptimal visual outcome. [...]it becomes imperative, particularly in the premium channel, that we obtain high-resolution retinal images using OCT to reveal changes not visible using an indirect lens at the slit lamp. According to CMS payment guidelines, screening OCTs are not reimbursed unless a qualifying medical diagnosis is found. A recent analysis sought to determine the cost-effectiveness of OCT in the preoperative evaluation of a base patient considering cataract surgery with a multifocal IOL.

Whether surgeons adopt cataract surgery-paired MIGS implants or a broader range of interventional therapies, our practices will change because we are so well positioned to meet patients' urgent need for glaucoma therapy beyond eye drops. Today, I use CyPass (Alcon Laboratories) or iStent (Glaukos) during cataract surgery, as well as standalone procedures such as the Kahook Dual Blade (New World Medical), Visco 360 (Sight Sciences) and XEN Gel Stent (Allergan). Insurance carriers vary widely in what they are willing to cover, despite the long-term benefits of reducing reliance on patients' compliance with drops to preserve vision and avoid major surgery.