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Microinterventional endocapsular nuclear fragmentation assisted cataract surgery versus conventional phacoemulsification using divide-and-conquer: a randomized controlled trial

Microinterventional endocapsular nuclear fragmentation assisted cataract surgery versus conventional phacoemulsification using divide-and-conquer: a randomized controlled trial - miLOOP trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53956
Enrollment
80
Registered
2023-01-31
Start date
2023-04-03
Completion date
Unknown
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cataract hard nucleus

Interventions

Microinterventional endocapsular nuclear fragmentation.

Sponsors

Oogziekenhuis Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age >= 18 years. Best corrected visual acuity < 0.2 (Snellen). Advanced visually significant nuclear sclerosis grade >= 5 (LOCS III).

Exclusion criteria

Exclusion criteria: Endothelial cell density (ECD) < 1500 mm-2. Corneal opacification (any cause). Corneal surgery or trauma.

Design outcomes

Primary

MeasureTime frame
Cumulative dispersed ultrasound energy (CDE) and endothelial cell loss.

Secondary

MeasureTime frame
Procedural time, adverse events, visual acuity.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)