Comparison of Two Fragmentation Modalities in Femtosecond... | NCT02898909

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

NCT02898909

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Terminated

Last Update Posted

Dec 12, 2019Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

nuclear lens fragmentation in 8 pieces
nuclear lens fragmentation in 16 pieces

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Major inclusion difficulties

Expanded Access Info

Start Date

Nov 15, 2016Actual

Primary Completion Date

Dec 21, 2017Actual

Completion Date

Dec 10, 2019Actual

First Submitted Date

Sep 8, 2016

First Submission Date that Met QC Criteria

Sep 8, 2016

First Posted Date

Sep 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2019

Last Update Posted Date

Dec 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
16 pieces fragmentation	Experimental		Device: nuclear lens fragmentation in 16 pieces
8 pieces fragmentation	Active Comparator		Device: nuclear lens fragmentation in 8 pieces

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nuclear lens fragmentation in 8 pieces	Device		8 pieces fragmentation
nuclear lens fragmentation in 16 pieces

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Luc FEBBRARO, MD	Fondation OPH A de Rothschild	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Opthalmologique A de Rothschild		Paris		75019	France

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases