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

Study Overview
=================
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.

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

Conditions
-----------------
Corneal Endothelial Cell Loss, Cataract, Astigmatism

Intervention / Treatment
-----------------
* Device: Femtosecond laser assisted cataract surgery with Active Sentry handpiece
* Procedure: Standard phacoemulsification with the Active Sentry handpiece
* Procedure: Standard phacoemulsification with the OZil handpiece


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corneal Endothelial Cell Loss, Centurion Vision System, Infiniti Vision System, cumulative dissipated energy, Phacoemulsification, Active Sentry handpiece, Laser Therapy, Ozil handpiece