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Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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.

Study details

Nuclear Cataract

NCT05736042

Oogziekenhuis Rotterdam

25 January 2024

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