Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

April 6, 2023 updated by: Oogziekenhuis Rotterdam

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: During surgery
Phaco energy (Centurion, Alcon)
During surgery
Change of corneal endothelial cell density (ECD)
Time Frame: Preoperative and at 3 months
Central cell density will be assessed
Preoperative and at 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oogziekenhuis Rotterdam

Collaborators

Carl Zeiss Meditec AG
Stichting Wetenschappelijk Onderzoek Het Oogziekenhuis Prof.dr H.J. Flieringa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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