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

NCT05119270 | Withdrawn FDA Device

• 1 other identifier: 21.225
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Central corneal thickness

  Baseline, 1 month, 3 months

• 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

Study Arms (3)

Femtosecond laser assisted cataract surgery with Active Sentry handpiece

EXPERIMENTAL

Participants suffering from cataract who are candidates for femtosecond laser assisted cataract surgery

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

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

Procedure: Standard phacoemulsification with the OZil handpiece

Interventions

Femtosecond laser assisted cataract surgery with Active Sentry handpiece DEVICE

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.

Femtosecond laser assisted cataract surgery with Active Sentry handpiece

Standard phacoemulsification with the Active Sentry handpiece PROCEDURE

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.

Standard phacoemulsification with the Active Sentry handpiece

Standard phacoemulsification with the OZil handpiece PROCEDURE

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.

Standard phacoemulsification with the OZil handpiece

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (13)

• 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.

  PMID: 6028631 BACKGROUND

• 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.

  PMID: 20000286 BACKGROUND

• 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/

  PMID: 32091677 BACKGROUND

• 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.

  PMID: 17276271 BACKGROUND

• 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.

  PMID: 27113876 BACKGROUND

• 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.

  PMID: 28991340 BACKGROUND

• 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.

  PMID: 26269445 BACKGROUND

• 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.

  PMID: 28540082 BACKGROUND

• 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.

  PMID: 30054849 BACKGROUND

• 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.

  PMID: 30140634 BACKGROUND

• 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.

  PMID: 24888390 BACKGROUND

• 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.

  PMID: 33740863 BACKGROUND

• 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.

  PMID: 25415300 BACKGROUND

MeSH Terms

Conditions

Corneal Endothelial Cell Loss; Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Lens Diseases; Refractive Errors

Study Officials

• Georges Durr, MD, FRCSC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 15, 2021
• Study Start: December 1, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)