The study was withdrawn prior to participant enrollment.
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
Sponsor study identifier
interventional
0
1 country
1
Study Start
December 1, 2021
Actual (reported)Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2, 2021
Actual (reported)November 15, 2021
Actual (reported)December 1, 2021
Actual (reported)March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Central corneal thickness
Baseline, 1 month, 3 months
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
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.
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4, Canada
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.
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.
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/
Georges Durr, MD, FRCSC
Centre hospitalier de l'Université de Montréal (CHUM)
0 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2021
First Posted
November 15, 2021
Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision
Postoperative residual astigmatism
Baseline, 3 months
Binocular uncorrected visual acuities for distance (6 meters)
Baseline, 1 day, 2 weeks, 1 month, 3 months
Patient reported visual disturbances
Baseline, 3 months
Participants suffering from cataract who are candidates for standard phacoemulsification with the traditional OZil 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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Study Start
December 1, 2021
Actual (reported)Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 19, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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