Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

Sponsor

Oogziekenhuis Rotterdam (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05736042

Collaborator

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

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nuclear Cataract	Device: Lens fragmentation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oogziekenhuis Rotterdam	Rotterdam		Netherlands

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oogziekenhuis Rotterdam

ClinicalTrials.gov Identifier:

NCT05736042

Other Study ID Numbers:

OZR-2022-07
NL83139.078.22

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Oogziekenhuis Rotterdam

LOCS III grade 5 or more

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Feb 21, 2023