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

July 4, 2023 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Comparison of Corneal Endothelial Cell Loss and Cumulative Dissipated Energy Between Femtosecond Laser Assisted Cataract Surgery and Standard Phacoemulsification With the Active Sentry or OZil Handpiece

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Phacoemulsification (phaco) has been the standard technique for cataract surgery for several decades. It involves the removal of the lens nucleus after ultrasound fragmentation. Recently, Femtosecond Laser Assisted Cataract Surgery (FLACS) has become a new popular method amongst ophthalmologists.

The femtosecond laser (LFS) is a new technology that is being used for cataract surgery. The LFS has a femtosecond pulse duration, which reduces damage to collateral tissue and increases the efficacy and safety of the procedure. The LenSx laser (Alcon Laboratories Inc., USA) is one of the most widely used LFS for cataract surgery and is part of the CENTURION Vision system. The LFS automates key steps in the procedure including capsulorhexis, incision making and phaco, limiting human variability and potentially improving the efficiency and safety of the surgery. 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.

Several handpieces are used to perform phacoemulsification. The traditional handpiece is named OZil and is part of the Infiniti Vision System (Alcon Laboratories Inc.) which was introduced in 2006 and has since revolutionized the phaco technique with its new rotational technology. This handpiece increased phaco efficacy by reducing core fragment repulsion, collateral tissue damage, and the amount of energy required. However, a new generation of handpiece called Active Sentry (Alcon Inc.), which is part of the new Active Fluidics technology, has now the added feature of detecting the pressure inside the eye in real time and adjusting it to avoid significant variations. This handpiece can also decrease the amount of fluid and energy used during the procedure, increasing the efficacy and safety of phacoemulsification.

Different methods to quantify the collateral damage caused by cataract surgeries are the count of endothelial cell loss (ECL) as well as the amount of energy required to fragment the lens (CDE: cumulative dissipated energy). FLACS may reduce the CDE required during phaco, thereby reducing the damage to the cornea of the eye (including the loss of endothelial cells of the cornea).

Despite a large number of publications on this topic, recent meta-analyses on the effect of FLACS on ECL and CDE were found to be inconsistent. Few studies have demonstrated a decrease in ECL as well as CDE required in patients undergoing FLACS when compared to standard phaco, but long-term results were not conclusive.

Given the novelty of the Active Sentry handpiece, little data on this new device exists in the literature. Based on what was found in the literature, this study will be the first to compare the following techniques: FLACS with Active Sentry, traditional phaco with Active Sentry, and traditional phaco with OZil.

The investigators hypothesize that the new FLACS technique will reduce the CDE required during phacoemulsification, thereby reducing the damage caused the cornea (i.e. loss of endothelial corneal cells).

In addition, the investigators hypothesize that patients undergoing standard phacoemulsification with the Active Sentry handpiece will have less corneal endothelial cell damage and require less CDE than participants undergoing standard phacoemulsification with OZil.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal
        • Contact:
        • Principal Investigator:
          • Georges Durr, MD, FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient (over 18 years of age)
  • Patients undergoing uncomplicated cataract surgery with intraocular lens implantation
  • Ability to provide informed consent;
  • Ability to be followed for the entire duration of the study.

Exclusion Criteria:

  • Minor patient (under 18 years of age)
  • Unable to give informed consent
  • Unable to be followed for the duration of the study
  • Another surgery combined with cataract extraction
  • History of ocular surgery
  • Patient with concomitant ocular diseases other than cataract (such as corneal, retinal, or glaucoma diseases)
  • Irregular corneal astigmatism or keratoconus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Femtosecond laser assisted cataract surgery with Active Sentry handpiece
Participants suffering from cataract who are candidates for femtosecond laser assisted cataract surgery
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.
Experimental: Standard phacoemulsification with the Active Sentry handpiece
Participants suffering from cataract who are candidates for standard phacoemulsification with the new Active Sentry handpiece
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.
Experimental: Standard phacoemulsification with the OZil handpiece
Participants suffering from cataract who are candidates for standard phacoemulsification with the traditional OZil handpiece
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal endothelial cell loss (Specular microscopy)
Time Frame: Baseline, 1 month, 3 months
Change in corneal endothelial cells count after cataract surgery
Baseline, 1 month, 3 months
Cumulative dissipated energy
Time Frame: Peroperatively
Amount of energy used during phacoemulsification
Peroperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central corneal thickness
Time Frame: Baseline, 1 month, 3 months
Change in central thickness of the corneal measured by a pachymeter.
Baseline, 1 month, 3 months
Postoperative residual astigmatism
Time Frame: Baseline, 3 months
Change in simulated keratometric values obtained by OPD-Scan.
Baseline, 3 months
Binocular uncorrected visual acuities for distance (6 meters)
Time Frame: Baseline, 1 day, 2 weeks, 1 month, 3 months
Evaluation of visual acuity change, measured using the Snellen chart.
Baseline, 1 day, 2 weeks, 1 month, 3 months
Patient reported visual disturbances
Time Frame: Baseline, 3 months
Evaluation of patient reported visual disturbances using a validated questionnaire for visual disturbances (CaT-PROM5)
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Georges Durr, MD, FRCSC, Centre Hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21.225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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