NCT02898909

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

September 8, 2016

Last Update Submit

December 10, 2019

Conditions

Cataract

Keywords

femtosecond laser-assisted cataract surgerynuclear lens fragmentation

Outcome Measures

Primary Outcomes (1)

  • energy delivered for lens nucleus aspiration during phacoemulsification

    ultrasound power delivered (measured in Hertz)

    approximatively 15 minutes

Study Arms (2)

16 pieces fragmentation

EXPERIMENTAL
Device: nuclear lens fragmentation in 16 pieces

8 pieces fragmentation

ACTIVE COMPARATOR
Device: nuclear lens fragmentation in 8 pieces

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient aged ≥ 18 years old
  • first Femtosecond Laser-assisted Cataract Surgery scheduled
  • cataract density ≥ 3 according to the lens opacities classification system (LOCS)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Opthalmologique A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Jean-Luc FEBBRARO, MD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

November 15, 2016

Primary Completion

December 21, 2017

Study Completion

December 10, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Locations

FR(1)