Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Nuclear Cataract

Intervention / Treatment
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* Device: Lens fragmentation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens fragmentation with miLOOP<br>Phacoemulsification with adjunctive lens fragmentation with the microinterventional microfilament loop device (miLOOP) | Device: Lens fragmentation<br>* Lens fragmentation with the microinterventional microfilament loop device (miLOOP)<br>|
| No Intervention: Controls<br>Phacoemulsification alone (no adjunctive lens fragmentation) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Total sugery time | During surgery | 
| Peri-operative complications | Any complications during surgery | During surgery | 
| Postoperative complications | Any complications after surgery | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LOCS III grade 5 or more