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Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

Primary Purpose

Nuclear Cataract

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Lens fragmentation

About this trial

This is an interventional treatment trial for Nuclear Cataract focused on measuring LOCS III grade 5 or more

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Oogziekenhuis RotterdamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lens fragmentation with miLOOP

Controls

Arm Description

Phacoemulsification with adjunctive lens fragmentation with the microinterventional microfilament loop device (miLOOP)

Phacoemulsification alone (no adjunctive lens fragmentation)

Outcomes

Primary Outcome Measures

Ultrasound cumulative dispersed energy (CDE)

Phaco energy (Centurion, Alcon)

Change of corneal endothelial cell density (ECD)

Central cell density will be assessed

Secondary Outcome Measures

Procedure time

Total sugery time

Peri-operative complications

Any complications during surgery

Postoperative complications

Any complications after surgery

Full Information

NCT ID

NCT05736042

First Posted

January 31, 2023

Last Updated

April 6, 2023

Sponsor

Oogziekenhuis Rotterdam

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05736042

Brief Title

Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 3, 2023 (Actual)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oogziekenhuis Rotterdam

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nuclear Cataract

Keywords

LOCS III grade 5 or more

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lens fragmentation with miLOOP

Arm Type

Experimental

Arm Description

Phacoemulsification with adjunctive lens fragmentation with the microinterventional microfilament loop device (miLOOP)

Arm Title

Controls

Arm Type

No Intervention

Arm Description

Phacoemulsification alone (no adjunctive lens fragmentation)

Intervention Type

Device

Intervention Name(s)

Lens fragmentation

Intervention Description

Lens fragmentation with the microinterventional microfilament loop device (miLOOP)

Primary Outcome Measure Information:

Title

Ultrasound cumulative dispersed energy (CDE)

Description

Phaco energy (Centurion, Alcon)

Time Frame

During surgery

Title

Change of corneal endothelial cell density (ECD)

Description

Central cell density will be assessed

Time Frame

Preoperative and at 3 months

Secondary Outcome Measure Information:

Title

Procedure time

Description

Total sugery time

Time Frame

During surgery

Title

Peri-operative complications

Description

Any complications during surgery

Time Frame

During surgery

Title

Postoperative complications

Description

Any complications after surgery

Time Frame

Up to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rene Wubbels

Phone

+31104023430

r.wubbels@oogziekenhuis.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Susan Marinissen

Phone

+31104023449

S.Marinissen@oogziekenhuis.nl

Facility Information:

Facility Name

Oogziekenhuis Rotterdam

City

Rotterdam

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oogziekenhuis Rotterdam

First Name & Middle Initial & Last Name & Degree

Bart Zijlmans

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

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