Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedApril 10, 2023
April 1, 2023
2.2 years
January 31, 2023
April 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (3)
Procedure time
During surgery
Peri-operative complications
During surgery
Postoperative complications
Up to 3 months
Study Arms (2)
Lens fragmentation with miLOOP
EXPERIMENTALPhacoemulsification with adjunctive lens fragmentation with the microinterventional microfilament loop device (miLOOP)
Controls
NO INTERVENTIONPhacoemulsification alone (no adjunctive lens fragmentation)
Interventions
Lens fragmentation with the microinterventional microfilament loop device (miLOOP)
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- Informed consent.
- Advanced visually significant nuclear sclerosis grade ≥ 5 (LOCS III).
You may not qualify if:
- Endothelial cell density (ECD) \< 1500 mm-2.
- Corneal opacification (any cause).
- Corneal surgery or trauma.
- Implant lens.
- Refraction surgery.
- Prior glaucoma surgery.
- Pseudoexfoliation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oogziekenhuis Rotterdam
Rotterdam, Netherlands
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2023
First Posted
February 21, 2023
Study Start
April 3, 2023
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
April 10, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share