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
- Treatment Surgery
- Optics and Refraction
- Lens and zonules
- Clinical Trial
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Contributors Conception and design of the study (TI, EC); data collection (TI, EC); analysis and interpretation (TI, DFC, EK, SM, EC, FTT, AV, IIKA); writing of the article (TI, DFC, EK, SM, EC, FTT, AV, IIKA); critical revision of the article (TI, DFC, EK, SM, EC, FTT, AV, IIKA); final approval of the article (TI, DFC, EK, SM, EC, FTT, AV, IIKA); obtained funding (TI); literature search (TI, EC); administrative, technical or logistic support (AV).
Funding This study was funded by IanTech, the device manufacturer.
Competing interests TI is the CEO of IanTech. DFC is a consultant for IanTech and has an ownership interest in the company. EK, EC and FTT have financial interests in IanTech. SM is a consultant for IanTech and Perfect Lens. AV received study funding from IanTech. IIKA has a consultancy (C), or received speaker fees (S) or research funding (R) from: Abbott Medical Optics (AMO), C,S,R; Acucela, C; Aerie Pharmaceuticals, C,R; Alcon, C,S,R; Allergan, C,S,R; ArcScan, C; Bausch and Lomb, C; Carl Zeiss Meditec, C,S,R; Centervue, C; Clarity Medical Systems, C; ElutiMed, C; Envisia Therapeutics, C; Equinox, C; Eyelight, C; ForSight Labs, C; Glaukos, C,R; Gore, C; IanTech, C; InjectSense, C; InnFocus, C; Iridex, C; iStar, C; Ivantis, C,R; KeLoTec, C; LayerBio, C; Leica Microsystems, C; New World Medical, C,R; Omega Ophthalmics, C; Ono Pharma, C; PolyActiva, C; Sanoculis, C; Santen, C; Science Based Health, C; SOLX, C; Stroma, C; TrueVision, C.
Patient consent Obtained.
Ethics Approval The study protocol was approved by the Institutional Review Board of the Clínica de Ojos Orillac-Calvo, Panama City, Panama.
Provenance and peer review Not commissioned; externally peer reviewed.
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