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

Primary Purpose

Cataract

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

nuclear lens fragmentation in 8 pieces

nuclear lens fragmentation in 16 pieces

About this trial

This is an interventional treatment trial for Cataract focused on measuring femtosecond laser-assisted cataract surgery, nuclear lens fragmentation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Fondation Opthalmologique A de Rothschild

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

16 pieces fragmentation

8 pieces fragmentation

Arm Description

Outcomes

Primary Outcome Measures

energy delivered for lens nucleus aspiration during phacoemulsification

ultrasound power delivered (measured in Hertz)

Secondary Outcome Measures

Full Information

NCT ID

NCT02898909

First Posted

September 8, 2016

Last Updated

December 10, 2019

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

1. Study Identification

Unique Protocol Identification Number

NCT02898909

Brief Title

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

Acronym

SLICES

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Terminated

Why Stopped

Major inclusion difficulties

Study Start Date

November 15, 2016 (Actual)

Primary Completion Date

December 21, 2017 (Actual)

Study Completion Date

December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

femtosecond laser-assisted cataract surgery, nuclear lens fragmentation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

16 pieces fragmentation

Arm Type

Experimental

Arm Title

8 pieces fragmentation

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

nuclear lens fragmentation in 8 pieces

Intervention Type

Device

Intervention Name(s)

nuclear lens fragmentation in 16 pieces

Primary Outcome Measure Information:

Title

energy delivered for lens nucleus aspiration during phacoemulsification

Description

ultrasound power delivered (measured in Hertz)

Time Frame

approximatively 15 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Luc FEBBRARO, MD

Organizational Affiliation

Fondation OPH A de Rothschild

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondation Opthalmologique A de Rothschild

City

Paris

ZIP/Postal Code

75019

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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