NCT05736042

Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Oogziekenhuis Rotterdam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nuclear Cataract

Interventions

Type	Name	Description
DEVICE	Lens fragmentation	Lens fragmentation with the microinterventional microfilament loop device (miLOOP)

Timeline

• Start date: 2023-04-03
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-02-21
• Last updated: 2023-04-10

Locations

1 site across 1 country: Netherlands