Comparison of Phacoemulsification and Corneal Damage Between FLACS and Standard Phaco With Two Handpieces

Summary

The main goal of this study is to compare traditional cataract surgery with two new technologies: the femtosecond laser and the new Active Sentry handpiece.

The femtosecond laser is used in several fields of ophthalmology and allows to automate multiple key steps of cataract surgery.

The new generation of handpiece called Active Sentry has the particularity to detect the pressure inside the eye in real time and to adjust it to avoid large variations.

Theses technologies would potentially increase the efficacy and safety of standard cataract surgery. This study therefore aims at evaluating the differences in cumulative dissipated energy and endothelial cell loss between femtosecond laser assisted cataract surgery with the new Active Sentry handpiece compared to standard phaco with new (Active Sentry) or older handpieces (OZil).

Conditions

• Corneal Endothelial Cell Loss
• Cataract
• Astigmatism

Interventions

DEVICE

Femtosecond laser assisted cataract surgery with Active Sentry handpiece

The LenSx laser (Alcon Laboratories Inc., USA) automates key steps in the procedure including capsulorhexis, incision making and phaco. The Frequency Domain - Optical Coherence Tomography (FD-OCT) optical imaging system provides high-resolution, real-time visualization of ocular structures and their dimensions. The device sends the results to the interface which programs the laser and indicates the exact location, size and depth of the desired incisions. Diagnostic tests: 1. Corneal topography: OPD-Scan Corneal topography photography, taken by specular reflection (OPD-Scan) by measuring corneal curvature, thickness and topography 2. Pachymetry: precise measurement of the thickness of the cornea using a pachymeter 3. Specular microscopy : Qualitative and quantitative analysis of the corneal endothelium.

PROCEDURE

Standard phacoemulsification with the Active Sentry handpiece

Phacoemulsification is done by using the Active Sentry handpiece to allow for a better control of the intraocular pressure throughout the surgery. Diagnostic tests: 1. Corneal topography: OPD-Scan Corneal topography photography, taken by specular reflection (OPD-Scan) by measuring corneal curvature, thickness and topography 2. Pachymetry: precise measurement of the thickness of the cornea using a pachymeter 3. Specular microscopy : Qualitative and quantitative analysis of the corneal endothelium.

PROCEDURE

Standard phacoemulsification with the OZil handpiece

Phacoemulsification is done by using the traditional OZil handpiece that allows rotational movement of the phaco tip. Diagnostic tests: 1. Corneal topography: OPD-Scan Corneal topography photography, taken by specular reflection (OPD-Scan) by measuring corneal curvature, thickness and topography 2. Pachymetry: precise measurement of the thickness of the cornea using a pachymeter 3. Specular microscopy : Qualitative and quantitative analysis of the corneal endothelium.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM)

  lead OTHER

Principal Investigators

• Georges Durr, MD, FRCSC · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2026-03-31

Completion

2026-03-31

FDA Device

Yes

Countries

• Canada

Study Locations