Microinterventional Endocapsular Nuclear Fragmentation As... | NCT05736042

Studies
Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

NCT05736042

Sponsor

Oogziekenhuis Rotterdam

Status

Unknown status

Last Update Posted

Apr 10, 2023Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Nuclear Cataract

Interventions

Lens fragmentation

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NL83139.078.22	Other Identifier	CCMO

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2023Actual

Primary Completion Date

Jun 2025Estimated

Completion Date

Jun 2025Estimated

First Submitted Date

Jan 31, 2023

First Submission Date that Met QC Criteria

Feb 9, 2023

First Posted Date

Feb 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2023

Last Update Posted Date

Apr 10, 2023Actual

Name	Class
Stichting Wetenschappelijk Onderzoek Het Oogziekenhuis Prof.dr H.J. Flieringa	UNKNOWN
Carl Zeiss Meditec AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lens fragmentation with miLOOP	Experimental	Phacoemulsification with adjunctive lens fragmentation with the microinterventional microfilament loop device (miLOOP)	Device: Lens fragmentation
Controls	No Intervention	Phacoemulsification alone (no adjunctive lens fragmentation)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lens fragmentation	Device	Lens fragmentation with the microinterventional microfilament loop device (miLOOP)	Lens fragmentation with miLOOP

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Procedure time	Total sugery time	During surgery
Peri-operative complications	Any complications during surgery	During surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rene Wubbels	Contact	+31104023430		r.wubbels@oogziekenhuis.nl
Susan Marinissen	Contact	+31104023449		S.Marinissen@oogziekenhuis.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oogziekenhuis Rotterdam	Recruiting	Rotterdam			Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided