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

Primary Purpose

Corneal Endothelial Cell Loss, Cataract, Astigmatism

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Femtosecond laser assisted cataract surgery with Active Sentry handpiece
Standard phacoemulsification with the Active Sentry handpiece
Standard phacoemulsification with the OZil handpiece
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Endothelial Cell Loss focused on measuring Corneal Endothelial Cell Loss, Centurion Vision System, Infiniti Vision System, cumulative dissipated energy, Phacoemulsification, Active Sentry handpiece, Laser Therapy, Ozil handpiece

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de l'Université de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Femtosecond laser assisted cataract surgery with Active Sentry handpiece

Standard phacoemulsification with the Active Sentry handpiece

Standard phacoemulsification with the OZil handpiece

Arm Description

Participants suffering from cataract who are candidates for femtosecond laser assisted cataract surgery

Participants suffering from cataract who are candidates for standard phacoemulsification with the new Active Sentry handpiece

Participants suffering from cataract who are candidates for standard phacoemulsification with the traditional OZil handpiece

Outcomes

Primary Outcome Measures

Corneal endothelial cell loss (Specular microscopy)
Change in corneal endothelial cells count after cataract surgery
Cumulative dissipated energy
Amount of energy used during phacoemulsification

Secondary Outcome Measures

Central corneal thickness
Change in central thickness of the corneal measured by a pachymeter.
Postoperative residual astigmatism
Change in simulated keratometric values obtained by OPD-Scan.
Binocular uncorrected visual acuities for distance (6 meters)
Evaluation of visual acuity change, measured using the Snellen chart.
Patient reported visual disturbances
Evaluation of patient reported visual disturbances using a validated questionnaire for visual disturbances (CaT-PROM5)

Full Information

First Posted
November 2, 2021
Last Updated
July 4, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT05119270
Brief Title
Comparison of Phacoemulsification and Corneal Damage Between FLACS and Standard Phaco With Two Handpieces
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Endothelial Cell Loss, Cataract, Astigmatism
Keywords
Corneal Endothelial Cell Loss, Centurion Vision System, Infiniti Vision System, cumulative dissipated energy, Phacoemulsification, Active Sentry handpiece, Laser Therapy, Ozil handpiece

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
3 groups will be compared: Group 1: 30 participants suffering from cataract who are candidates for femtosecond laser assisted cataract surgery Group 2: 30 participants suffering from cataract who are candidates for traditional cataract surgery with the Active Sentry handpiece Group 3: 30 participants suffering from cataract who are candidates for traditional cataract surgery with the OZil handpiece
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Femtosecond laser assisted cataract surgery with Active Sentry handpiece
Arm Type
Experimental
Arm Description
Participants suffering from cataract who are candidates for femtosecond laser assisted cataract surgery
Arm Title
Standard phacoemulsification with the Active Sentry handpiece
Arm Type
Experimental
Arm Description
Participants suffering from cataract who are candidates for standard phacoemulsification with the new Active Sentry handpiece
Arm Title
Standard phacoemulsification with the OZil handpiece
Arm Type
Experimental
Arm Description
Participants suffering from cataract who are candidates for standard phacoemulsification with the traditional OZil handpiece
Intervention Type
Device
Intervention Name(s)
Femtosecond laser assisted cataract surgery with Active Sentry handpiece
Intervention Description
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: Corneal topography: OPD-Scan Corneal topography photography, taken by specular reflection (OPD-Scan) by measuring corneal curvature, thickness and topography Pachymetry: precise measurement of the thickness of the cornea using a pachymeter Specular microscopy : Qualitative and quantitative analysis of the corneal endothelium.
Intervention Type
Procedure
Intervention Name(s)
Standard phacoemulsification with the Active Sentry handpiece
Intervention Description
Phacoemulsification is done by using the Active Sentry handpiece to allow for a better control of the intraocular pressure throughout the surgery. Diagnostic tests: Corneal topography: OPD-Scan Corneal topography photography, taken by specular reflection (OPD-Scan) by measuring corneal curvature, thickness and topography Pachymetry: precise measurement of the thickness of the cornea using a pachymeter Specular microscopy : Qualitative and quantitative analysis of the corneal endothelium.
Intervention Type
Procedure
Intervention Name(s)
Standard phacoemulsification with the OZil handpiece
Intervention Description
Phacoemulsification is done by using the traditional OZil handpiece that allows rotational movement of the phaco tip. Diagnostic tests: Corneal topography: OPD-Scan Corneal topography photography, taken by specular reflection (OPD-Scan) by measuring corneal curvature, thickness and topography Pachymetry: precise measurement of the thickness of the cornea using a pachymeter Specular microscopy : Qualitative and quantitative analysis of the corneal endothelium.
Primary Outcome Measure Information:
Title
Corneal endothelial cell loss (Specular microscopy)
Description
Change in corneal endothelial cells count after cataract surgery
Time Frame
Baseline, 1 month, 3 months
Title
Cumulative dissipated energy
Description
Amount of energy used during phacoemulsification
Time Frame
Peroperatively
Secondary Outcome Measure Information:
Title
Central corneal thickness
Description
Change in central thickness of the corneal measured by a pachymeter.
Time Frame
Baseline, 1 month, 3 months
Title
Postoperative residual astigmatism
Description
Change in simulated keratometric values obtained by OPD-Scan.
Time Frame
Baseline, 3 months
Title
Binocular uncorrected visual acuities for distance (6 meters)
Description
Evaluation of visual acuity change, measured using the Snellen chart.
Time Frame
Baseline, 1 day, 2 weeks, 1 month, 3 months
Title
Patient reported visual disturbances
Description
Evaluation of patient reported visual disturbances using a validated questionnaire for visual disturbances (CaT-PROM5)
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Catherine Tessier, MSc
Phone
1-514-890-8000
Ext
11550
Email
marie-catherine.tessier.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kenan Bachour, MD
Phone
1-514-890-8000
Ext
11550
Email
kenan.bachour@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges Durr, MD, FRCSC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Catherine Tessier, MSc
Phone
1-514-890-8000
Ext
11550
Email
marie-catherine.tessier.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Georges Durr, MD, FRCSC

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6028631
Citation
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Results Reference
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20000286
Citation
Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009 Dec;25(12):1053-60. doi: 10.3928/1081597X-20091117-04.
Results Reference
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Citation
Bille JF, editor. High Resolution Imaging in Microscopy and Ophthalmology: New Frontiers in Biomedical Optics [Internet]. Cham (CH): Springer; 2019. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK554051/
Results Reference
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17276271
Citation
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Citation
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Comparison of Phacoemulsification and Corneal Damage Between FLACS and Standard Phaco With Two Handpieces

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