Clinical trial NCT05119270: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Corneal endothelial cell loss (Specular microscopy)
timeFrame: Baseline, 1 month, 3 months
measure: Cumulative dissipated energy
timeFrame: Peroperatively
Secondary outcomes:
measure: Central corneal thickness
timeFrame: Baseline, 1 month, 3 months
measure: Postoperative residual astigmatism
timeFrame: Baseline, 3 months
measure: Binocular uncorrected visual acuities for distance (6 meters)
timeFrame: Baseline, 1 day, 2 weeks, 1 month, 3 months
measure: Patient reported visual disturbances
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Georges Durr, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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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/
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citation: Saeedi OJ, Chang LY, Ong SR, Karim SA, Abraham DS, Rosenthal GL, Hammer A, Spagnolo BV, Betancourt AE. Comparison of cumulative dispersed energy (CDE) in femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification. Int Ophthalmol. 2019 Aug;39(8):1761-1766. doi: 10.1007/s10792-018-0996-x. Epub 2018 Jul 27.
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citation: Jiraskova N, Stepanov A. OUR EXPERIENCE WITH ACTIVE SENTRY AND CENTURION OZIL HANDPIECES. Cesk Slov Oftalmol. 2021 Winter;77(1):18-21. doi: 10.31348/2021/1.
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