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

Not Applicable

Terminated

• Conditions: Cataract
• Interventions: Device: nuclear lens fragmentation in 16 pieces; Device: nuclear lens fragmentation in 8 pieces

• Registration Number: NCT02898909
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-13
• Study Start: 2016-11-15
• Primary Completion: 2017-12-21
• Status Verified: 2019-12
• Study Completion: 2019-12-10
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
16 pieces fragmentation	nuclear lens fragmentation in 16 pieces	-
8 pieces fragmentation	nuclear lens fragmentation in 8 pieces	-

Primary Outcome Measures

Name	Time	Method
energy delivered for lens nucleus aspiration during phacoemulsification	approximatively 15 minutes	ultrasound power delivered (measured in Hertz)

Trial Locations

Locations (1)

Fondation Opthalmologique A de Rothschild; 🇫🇷 Paris, France