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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Lens fragmentation with the microinterventional microfilament loop device (miLOOP)
Oogziekenhuis Rotterdam
Rotterdam, Netherlands
RECRUITINGUltrasound cumulative dispersed energy (CDE)
Phaco energy (Centurion, Alcon)
Time frame: During surgery
Change of corneal endothelial cell density (ECD)
Central cell density will be assessed
Time frame: Preoperative and at 3 months
Procedure time
Total sugery time
Time frame: During surgery
Peri-operative complications
Any complications during surgery
Time frame: During surgery
Postoperative complications
Any complications after surgery
Time frame: Up to 3 months
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