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

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.

Study Overview

• Status: Recruiting
• Conditions: Nuclear Cataract
• Intervention / Treatment: Device: Lens fragmentation

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Marinissen; Phone Number: +31104023449; Email: S.Marinissen@oogziekenhuis.nl
• Study Contact Backup: Name: Rene Wubbels; Phone Number: +31104023430; Email: r.wubbels@oogziekenhuis.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Oogziekenhuis Rotterdam
    • Contact: Oogziekenhuis Rotterdam
    • Principal Investigator: Bart Zijlmans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens fragmentation with miLOOP; Phacoemulsification with adjunctive lens fragmentation with the microinterventional microfilament loop device (miLOOP)	Device: Lens fragmentation; Lens fragmentation with the microinterventional microfilament loop device (miLOOP)
No Intervention: Controls; Phacoemulsification alone (no adjunctive lens fragmentation)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oogziekenhuis Rotterdam
• Collaborators: Carl Zeiss Meditec AG; Stichting Wetenschappelijk Onderzoek Het Oogziekenhuis Prof.dr H.J. Flieringa

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: LOCS III grade 5 or more
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: OZR-2022-07; NL83139.078.22 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No