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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: Cataract

Treatments: Device: nuclear lens fragmentation in 16 pieces; Device: nuclear lens fragmentation in 8 pieces

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02898909

JFO_2015_44

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

16 pieces fragmentation

Experimental group

Treatment:

Device: nuclear lens fragmentation in 16 pieces

8 pieces fragmentation

Active Comparator group

Treatment:

Device: nuclear lens fragmentation in 8 pieces