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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05119270
• Other study ID #: 21.225
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Marie-Catherine Tessier, MSc
• Phone: 1-514-890-8000
• Email: marie-catherine.tessier.chum[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Corneal Endothelial Cell Loss

Intervention

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: 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.

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: 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.
• 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: 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.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Al-Mohtaseb Z, He X, Yesilirmak N, Waren D, Donaldson KE. Comparison of Corneal Endothelial Cell Loss Between Two Femtosecond Laser Platforms and Standard Phacoemulsification. J Refract Surg. 2017 Oct 1;33(10):708-712. doi: 10.3928/1081597X-20170731-01. — View Citation

Bascaran L, Alberdi T, Martinez-Soroa I, Sarasqueta C, Mendicute J. Differences in energy and corneal endothelium between femtosecond laser-assisted and conventional cataract surgeries: prospective, intraindividual, randomized controlled trial. Int J Ophthalmol. 2018 Aug 18;11(8):1308-1316. doi: 10.18240/ijo.2018.08.10. eCollection 2018. — View 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/ — View Citation

Chen X, Xiao W, Ye S, Chen W, Liu Y. Efficacy and safety of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification for cataract: a meta-analysis of randomized controlled trials. Sci Rep. 2015 Aug 13;5:13123. doi: 10.1038/srep13123. — View Citation

Ho JW, Afshari NA. Advances in cataract surgery: preserving the corneal endothelium. Curr Opin Ophthalmol. 2015 Jan;26(1):22-7. doi: 10.1097/ICU.0000000000000121. — View 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. — View Citation

Kelman CD. Phaco-emulsification and aspiration. A new technique of cataract removal. A preliminary report. Am J Ophthalmol. 1967 Jul;64(1):23-35. No abstract available. — View Citation

Krarup T, Holm LM, la Cour M, Kjaerbo H. Endothelial cell loss and refractive predictability in femtosecond laser-assisted cataract surgery compared with conventional cataract surgery. Acta Ophthalmol. 2014 Nov;92(7):617-22. doi: 10.1111/aos.12406. Epub 2014 Jun 2. — View Citation

Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044. — View 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. — View 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. — View Citation

Solomon KD, Lorente R, Fanney D, Cionni RJ. Clinical study using a new phacoemulsification system with surgical intraocular pressure control. J Cataract Refract Surg. 2016 Apr;42(4):542-9. doi: 10.1016/j.jcrs.2016.01.037. — View Citation

Ye Z, Li Z, He S. A Meta-Analysis Comparing Postoperative Complications and Outcomes of Femtosecond Laser-Assisted Cataract Surgery versus Conventional Phacoemulsification for Cataract. J Ophthalmol. 2017;2017:3849152. doi: 10.1155/2017/3849152. Epub 2017 Apr 30. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal endothelial cell loss (Specular microscopy)	Change in corneal endothelial cells count after cataract surgery	Baseline, 1 month, 3 months
Primary	Cumulative dissipated energy	Amount of energy used during phacoemulsification	Peroperatively
Secondary	Central corneal thickness	Change in central thickness of the corneal measured by a pachymeter.	Baseline, 1 month, 3 months
Secondary	Postoperative residual astigmatism	Change in simulated keratometric values obtained by OPD-Scan.	Baseline, 3 months
Secondary	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
Secondary	Patient reported visual disturbances	Evaluation of patient reported visual disturbances using a validated questionnaire for visual disturbances (CaT-PROM5)	Baseline, 3 months