Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

Not Applicable

Recruiting

• Conditions: Nuclear Cataract
• Interventions: Device: Lens fragmentation

• Registration Number: NCT05736042
• Lead Sponsor: Oogziekenhuis Rotterdam

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 available

Study Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Status Verified: 2023-04
• Study Start: 2023-04-03
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lens fragmentation with miLOOP	Lens fragmentation	Phacoemulsification with adjunctive lens fragmentation with the microinterventional microfilament loop device (miLOOP)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Postoperative complications	Up to 3 months	Any complications after surgery
Peri-operative complications	During surgery	Any complications during surgery
Procedure time	During surgery	Total sugery time

Trial Locations

Locations (1)

Oogziekenhuis Rotterdam; 🇳🇱 Rotterdam, Netherlands