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Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study.

ABSTRACT: AIM:To assess the safety and efficacy of microinterventional endocapsular nuclear fragmentation in moderate to severe cataracts. METHODS:This 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. RESULTS:Only 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. CONCLUSIONS:Microinterventional 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 NUMBER:NCT02843594.

SUBMITTER: Ianchulev T

PROVIDER: S-EPMC6362801 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study.

Ianchulev Tsontcho T Chang David F DF Koo Edward E MacDonald Susan S Calvo Ernesto E Tyson Farrell Toby FT Vasquez Andrea A Ahmed Iqbal Ike K IIK

The British journal of ophthalmology 20180418 2

<h4>Aim</h4>To assess the safety and efficacy of microinterventional endocapsular nuclear fragmentation in moderate to severe cataracts.<h4>Methods</h4>This 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 ...[more]

PMID: 29669780

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Project description:BackgroundRespiratory syncytial virus (RSV) is a leading cause of lower respiratory tract disease among infants and young children worldwide, especially in low- and middle-income countries (LMICs). RSM01 is a novel, highly potent, half-life-extended anti-RSV monoclonal antibody (mAb) candidate primarily being developed for LMICs. Here we present the preclinical characterisation and results of a phase 1 trial of RSM01.MethodsPreclinical characterisation of RSM01 was conducted using in-vitro neutralization assays and cotton rat models. In the first-in-human, double-blind, phase 1 trial, 56 healthy adults were randomised 6:1 within dose cohorts to receive a single dose of RSM01 (n = 48) or placebo (n = 8): 300 mg intravenously (IV), 300 mg intramuscularly (IM) or 1000 mg IV (parallel cohorts), 3000 mg IV, and an expansion cohort of 600 mg IM. Systemic solicited adverse events (AEs) were assessed through day 7; unsolicited AEs were collected through day 151. Pharmacokinetics and anti-drug antibodies (ADA) to RSM01 were assessed using immunoassays. A population pharmacokinetics model predicted paediatric pharmacokinetics parameters using allometric scaling and age-specific population weight statistics of North American and African infants.ResultsRSM01 exhibited highly potent neutralizing activity in the single ng/mL range (0.7-6.4) against diverse RSV-A and RSV-B isolates in vitro. RSM01 also demonstrated prophylactic efficacy in cotton rat models with both RSV subtypes. In the phase 1 clinical trial, the most common unsolicited AEs were COVID-19 (2/48), headache (2/48), and nausea (2/48), all in RSM01-treated participants. The only systemic solicited AEs reported were headache (5/48) and tiredness (2/48) in participants receiving RSM01. No serious AEs or deaths were reported. The half-life of RSM01 was 78 days with dose-proportional increases in Tmax and AUClast after IV administration. Among RSM01-treated participants, 2/48 were ADA positive at baseline, and 1/48 seroconverted to ADA-positive post-baseline.ConclusionsRSM01 is a highly potent, half-life-extended, RSV-neutralising mAb candidate that was shown to be well tolerated in healthy adults. The rate of ADA to RSM01 was low. The long half-life of RSM01 and pharmacokinetics profile support further development of RSM01 as a potential single dose per season prophylaxis to prevent RSV disease in infants.Trial registrationClinicaltrials.gov NCT05118386, Nov 12, 2021.

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Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study.

Publications

Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study.

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