Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2025-06-30

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.

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Detailed Description

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Conditions

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Nuclear Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lens fragmentation with miLOOP

Phacoemulsification with adjunctive lens fragmentation with the microinterventional microfilament loop device (miLOOP)

Group Type EXPERIMENTAL

Lens fragmentation

Intervention Type DEVICE

Lens fragmentation with the microinterventional microfilament loop device (miLOOP)

Controls

Phacoemulsification alone (no adjunctive lens fragmentation)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lens fragmentation

Lens fragmentation with the microinterventional microfilament loop device (miLOOP)

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No