Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery Versus Conventional Phacoemulsification Using Divide-and-conquer: a Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05736042

Enrollment

Registered

2023-02-21

Start date

2023-04-03

Completion date

2025-06-30

Last updated

2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nuclear Cataract

Keywords

LOCS III grade 5 or more

Brief summary

Rationale: In cataract surgery, fragmentation of a hard nucleus requires relatively much ultrasound energy. It is suspected that the level of energy used is associated with the degree of corneal endothelial loss. Recently, it was demonstrated that with miLOOP (Zeiss Meditec) assisted nuclear fragmentation ultrasound energy can be substantially reduced. Objective: To compare miLOOP assisted cataract surgery and conventional surgery with respect to the energy needed for phacoemulsification and loss of corneal endothelial cells. Study design: Randomized, controlled trial. Study population: Patients with nuclear cataract of a grade ≥ 5. Intervention: Microinterventional endocapsular nuclear fragmentation. Main study parameters: Cumulative dispersed ultrasound energy (CDE) and endothelial cell loss.

Interventions

DEVICELens fragmentation

Lens fragmentation with the microinterventional microfilament loop device (miLOOP)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years. * Informed consent. * Advanced visually significant nuclear sclerosis grade ≥ 5 (LOCS III).

Exclusion criteria

* Endothelial cell density (ECD) \< 1500 mm-2. * Corneal opacification (any cause). * Corneal surgery or trauma. * Implant lens. * Refraction surgery. * Prior glaucoma surgery. * Pseudoexfoliation.

Design outcomes

Primary

Measure	Time frame	Description
Ultrasound cumulative dispersed energy (CDE)	During surgery	Phaco energy (Centurion, Alcon)
Change of corneal endothelial cell density (ECD)	Preoperative and at 3 months	Central cell density will be assessed

Secondary

Measure	Time frame	Description
Procedure time	During surgery	Total sugery time
Peri-operative complications	During surgery	Any complications during surgery
Postoperative complications	Up to 3 months	Any complications after surgery

Countries

Netherlands

Contacts

Primary ContactRene Wubbels

r.wubbels@oogziekenhuis.nl+31104023430

Backup ContactSusan Marinissen

S.Marinissen@oogziekenhuis.nl+31104023449

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026