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Comparison of Two Fragmentation Modalities in Femtosecond Laser-assisted Cataract Surgery

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02898909
Acronym
SLICES
Enrollment
5
Registered
2016-09-13
Start date
2016-11-15
Completion date
2019-12-10
Last updated
2019-12-12

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

Conditions

Cataract

Keywords

femtosecond laser-assisted cataract surgery, nuclear lens fragmentation

Brief summary

Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed. It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of ultrasonic energy. The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal transparency.

Interventions

DEVICEnuclear lens fragmentation in 8 pieces
DEVICEnuclear lens fragmentation in 16 pieces

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patient aged ≥ 18 years old * first Femtosecond Laser-assisted Cataract Surgery scheduled * cataract density ≥ 3 according to the lens opacities classification system (LOCS)

Exclusion criteria

* corneal guttata, uncontrolled glaucoma * shallow depth of anterior chamber * patient's refusal to participate in the study * pregnant or breast feeding patient * patient under legal protection * no health coverage

Design outcomes

Primary

MeasureTime frameDescription
energy delivered for lens nucleus aspiration during phacoemulsificationapproximatively 15 minutesultrasound power delivered (measured in Hertz)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026