Corneal Endothelial Cell LossNCT05119270
Comparison of Phacoemulsification and Corneal Damage Between FLACS and Standard Phaco With Two Handpieces
A study testing Femtosecond laser assisted cataract surgery with Active Sentry handpiece, Standard phacoemulsification with the Active Sentry handpiece and Standard phacoemulsification with the OZil handpiece in people with Corneal Endothelial Cell Loss and Cataract, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Endothelial Cell Loss, Cataract, Astigmatism
- What is being tested?
- Femtosecond laser assisted cataract surgery with Active Sentry handpiece, Standard phacoemulsification with the Active Sentry handpiece and Standard phacoemulsification with the OZil handpiece
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2021to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
About this study
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
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.
Read more
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).
Read the 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.
- Conditions
- Corneal Endothelial Cell Loss, Cataract, Astigmatism
- Being tested
- Femtosecond laser assisted cataract surgery with Active Sentry handpiece, Standard phacoemulsification with the Active Sentry handpiece, Standard phacoemulsification with the OZil handpiece
- Keywords
- Corneal Endothelial Cell Loss, Centurion Vision System, Infiniti Vision System, cumulative dissipated energy, Phacoemulsification, Active Sentry handpiece, Laser Therapy, Ozil handpiece
- Medical subject headings
- Corneal Endothelial Cell Loss, Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond laser assisted cataract surgery with Active Sentry handpieceDevice
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.
Standard phacoemulsification with the Active Sentry handpieceProcedure or surgery
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 handpieceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Femtosecond laser assisted cataract surgery with Active Sentry handpiece | Experimental | Participants suffering from cataract who are candidates for femtosecond laser assisted cataract surgery Receives: Device: Femtosecond laser assisted cataract surgery with Active Sentry handpiece |
| Standard phacoemulsification with the Active Sentry handpiece | Experimental | Participants suffering from cataract who are candidates for standard phacoemulsification with the new Active Sentry handpiece Receives: Procedure: Standard phacoemulsification with the Active Sentry handpiece |
| Standard phacoemulsification with the OZil handpiece | Experimental | Participants suffering from cataract who are candidates for standard phacoemulsification with the traditional OZil handpiece Receives: Procedure: Standard phacoemulsification with the OZil handpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal endothelial cell loss (Specular microscopy)
Change in corneal endothelial cells count after cataract surgery
Measured: Baseline, 1 month, 3 months
Cumulative dissipated energy
Amount of energy used during phacoemulsification
Measured: Peroperatively
Secondary outcomes (4)
Central corneal thickness
Change in central thickness of the corneal measured by a pachymeter.
Measured: Baseline, 1 month, 3 months
Postoperative residual astigmatism
Change in simulated keratometric values obtained by OPD-Scan.
Measured: Baseline, 3 months
Binocular uncorrected visual acuities for distance (6 meters)
Evaluation of visual acuity change, measured using the Snellen chart.
Measured: 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)
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Dec 2021
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Why it stopped: The study was withdrawn prior to participant enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Corneal Endothelial Cell LossStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges Durr, MD, FRCSC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119270
- Sponsor's protocol ID
- 21.225
- Status last verified
- Mar 2026
- First submitted
- 2 Nov 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 6028631Nagy 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.
PubMed 20000286Bille 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/
PubMed 32091677Liu 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.
PubMed 17276271Solomon 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.
PubMed 27113876Al-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.
PubMed 28991340Chen 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.
PubMed 26269445Ye 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.
PubMed 28540082Saeedi 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.
PubMed 30054849Bascaran 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.
PubMed 30140634Krarup 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.
PubMed 24888390Jiraskova 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.
PubMed 33740863Ho 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.
PubMed 25415300
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05119270
- Acronym / sponsor ID
- 21.225
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn prior to participant enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Femtosecond laser assisted cataract surgery with Active Sentry handpiece | Experimental | Device: Femtosecond laser assisted cataract surgery with Active Sentry handpieceParticipants suffering from cataract who are candidates for femtosecond laser assisted cataract surgery |
| Standard phacoemulsification with the Active Sentry handpiece | Experimental | Procedure: Standard phacoemulsification with the Active Sentry handpieceParticipants suffering from cataract who are candidates for standard phacoemulsification with the new Active Sentry handpiece |
| Standard phacoemulsification with the OZil handpiece | Experimental | Procedure: Standard phacoemulsification with the OZil handpieceParticipants suffering from cataract who are candidates for standard phacoemulsification with the traditional OZil handpiece |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femtosecond laser assisted cataract surgery with Active Sentry handpieceThe 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. | Device | Femtosecond laser assisted cataract surgery with Active Sentry handpiece |
| Standard phacoemulsification with the Active Sentry handpiecePhacoemulsification 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. | Procedure or surgery | Standard phacoemulsification with the Active Sentry handpiece |
| Standard phacoemulsification with the OZil handpiecePhacoemulsification 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. | Procedure or surgery | Standard phacoemulsification with the OZil handpiece |
Primary outcome
Corneal endothelial cell loss (Specular microscopy)
Time frame: Baseline, 1 month, 3 months
Change in corneal endothelial cells count after cataract surgery
Cumulative dissipated energy
Time frame: Peroperatively
Amount of energy used during phacoemulsification
4 secondary outcomes
Central corneal thickness
Time frame: Baseline, 1 month, 3 months
Postoperative residual astigmatism
Time frame: Baseline, 3 months
Binocular uncorrected visual acuities for distance (6 meters)
Time frame: Baseline, 1 day, 2 weeks, 1 month, 3 months
Patient reported visual disturbances
Time frame: Baseline, 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 6028631Kelman 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.
- Background: PubMed 20000286Nagy 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.
- Background: PubMed 32091677Bille 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/
- Background: PubMed 17276271Liu 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.
- Background: PubMed 27113876Solomon 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.
- Background: PubMed 28991340Al-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.
- Background: PubMed 26269445Chen 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.
- Background: PubMed 28540082Ye 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.
- Background: PubMed 30054849Saeedi 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.
- Background: PubMed 30140634Bascaran 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.
- Background: PubMed 24888390Krarup 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.
- Background: PubMed 33740863Jiraskova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges Durr, MD, FRCSC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femtosecond laser assisted cataract surgery with Active Sentry handpiece, Standard phacoemulsification with the Active Sentry handpiece and Standard phacoemulsification with the OZil handpiece in people with Corneal Endothelial Cell Loss and Cataract, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal endothelial cell loss (Specular microscopy) (time frame: Baseline, 1 month, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05119270, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.