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

NCT ID: NCT02898909

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-15

Study Completion Date

2019-12-10

Brief Summary

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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

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Conditions

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Cataract

Keywords

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femtosecond laser-assisted cataract surgery nuclear lens fragmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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16 pieces fragmentation

Group Type EXPERIMENTAL

nuclear lens fragmentation in 16 pieces

Intervention Type DEVICE

8 pieces fragmentation

Group Type ACTIVE_COMPARATOR

nuclear lens fragmentation in 8 pieces

Intervention Type DEVICE

Interventions

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nuclear lens fragmentation in 8 pieces

Intervention Type DEVICE

nuclear lens fragmentation in 16 pieces

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Luc FEBBRARO, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation OPH A de Rothschild

Locations

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Fondation Opthalmologique A de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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JFO_2015_44

Identifier Type: -

Identifier Source: org_study_id