Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

Oogziekenhuis Rotterdam

Status: Enrolling

Conditions: Nuclear Cataract

Treatments: Device: Lens fragmentation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05736042

NL83139.078.22 (Other Identifier)

OZR-2022-07

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Lens fragmentation with miLOOP

Experimental group

Description:

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

Treatment:

Device: Lens fragmentation

Controls

No Intervention group

Description:

Phacoemulsification alone (no adjunctive lens fragmentation)