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Device

FLACS vs Standard Phacoemulsification for Cataracts

N/A
Recruiting
Led By Georges Durr, MD, FRCSC
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing uncomplicated cataract surgery with intraocular lens implantation
Be older than 18 years old
Must not have
Patient with concomitant ocular diseases other than cataract (such as corneal, retinal, or glaucoma diseases)
History of ocular surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will help determine if using new technologies during cataract surgery is more effective and safe than using traditional methods.

Who is the study for?
This trial is for adults over 18 who need cataract surgery with lens implantation and can consent to participate. They must be able to attend all study visits. It's not for those under 18, unable to consent or follow-up, having additional eye surgeries, past ocular surgeries, irregular corneal astigmatism/keratoconus, or other eye diseases.
What is being tested?
The study compares traditional cataract surgery against two newer technologies: femtosecond laser-assisted surgery using the Active Sentry handpiece and standard phacoemulsification with either the new Active Sentry or older OZil handpieces. The focus is on energy used during surgery and health of corneal cells afterwards.
What are the potential side effects?
Potential side effects may include variations in intraocular pressure due to device performance which could affect vision temporarily. There might also be a risk of endothelial cell loss leading to corneal damage; however, these technologies aim to minimize such risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having a straightforward cataract surgery with lens replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have eye conditions other than cataracts.
Select...
I have had eye surgery in the past.
Select...
I cannot commit to the full duration of the study.
Select...
I am under 18 years old.
Select...
I have an irregularly shaped cornea or keratoconus.
Select...
I am unable to understand and agree to the study's details on my own.
Select...
I am having another surgery in addition to my cataract removal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Corneal endothelial cell loss (Specular microscopy)
Cumulative dissipated energy
Secondary study objectives
Binocular uncorrected visual acuities for distance (6 meters)
Central corneal thickness
Patient reported visual disturbances
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Standard phacoemulsification with the OZil handpieceExperimental Treatment1 Intervention
Participants suffering from cataract who are candidates for standard phacoemulsification with the traditional OZil handpiece
Group II: Standard phacoemulsification with the Active Sentry handpieceExperimental Treatment1 Intervention
Participants suffering from cataract who are candidates for standard phacoemulsification with the new Active Sentry handpiece
Group III: Femtosecond laser assisted cataract surgery with Active Sentry handpieceExperimental Treatment1 Intervention
Participants suffering from cataract who are candidates for femtosecond laser assisted cataract surgery

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,430 Total Patients Enrolled
2 Trials studying Cataract
58 Patients Enrolled for Cataract
Georges Durr, MD, FRCSCPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
2 Previous Clinical Trials
70 Total Patients Enrolled
1 Trials studying Cataract
20 Patients Enrolled for Cataract

Media Library

Femtosecond laser assisted cataract surgery with Active Sentry handpiece (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05119270 — N/A
Cataract Research Study Groups: Femtosecond laser assisted cataract surgery with Active Sentry handpiece, Standard phacoemulsification with the Active Sentry handpiece, Standard phacoemulsification with the OZil handpiece
Cataract Clinical Trial 2023: Femtosecond laser assisted cataract surgery with Active Sentry handpiece Highlights & Side Effects. Trial Name: NCT05119270 — N/A
Femtosecond laser assisted cataract surgery with Active Sentry handpiece (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05119270 — N/A
~23 spots leftby Nov 2025
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