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

December 10, 2019 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Opthalmologique A de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 16 pieces fragmentation
Device: nuclear lens fragmentation in 16 pieces
Active Comparator: 8 pieces fragmentation
Device: nuclear lens fragmentation in 8 pieces

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
energy delivered for lens nucleus aspiration during phacoemulsification
Time Frame: approximatively 15 minutes
ultrasound power delivered (measured in Hertz)
approximatively 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Jean-Luc FEBBRARO, MD, Fondation OPH A de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2016

Primary Completion (Actual)

December 21, 2017

Study Completion (Actual)

December 10, 2019

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JFO_2015_44

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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