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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am having a straightforward cataract surgery with lens replacement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Corneal endothelial cell loss (Specular microscopy)
Cumulative dissipated energy
Secondary outcome measures
Binocular uncorrected visual acuities for distance (6 meters)
Central corneal thickness
Patient reported visual disturbances
+1 moreTrial 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
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,547 Total Patients Enrolled
1 Trials studying Cataract
20 Patients Enrolled for Cataract
Georges Durr, MD, FRCSCPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
2 Previous Clinical Trials
110 Total Patients Enrolled
1 Trials studying Cataract
20 Patients Enrolled for Cataract
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have eye conditions other than cataracts.I have had eye surgery in the past.I am having a straightforward cataract surgery with lens replacement.I cannot commit to the full duration of the study.I am under 18 years old.I have an irregularly shaped cornea or keratoconus.I am unable to understand and agree to the study's details on my own.I am having another surgery in addition to my cataract removal.I am over 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Femtosecond laser assisted cataract surgery with Active Sentry handpiece
- Group 2: Standard phacoemulsification with the Active Sentry handpiece
- Group 3: Standard phacoemulsification with the OZil handpiece
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What objectives has this experimental trial set out to achieve?
"This clinical trial aspires to measure Cumulative dissipated energy, and secondary metrics include Central corneal thickness, Binocular uncorrected visual acuities for distance (6 meters), and Patient reported visual disturbances. These outcomes will be evaluated over Baseline, 1 month, 3 months intervals respectively."
Answered by AI
What is the current enrollment for this experiment?
"Affirmative. The information on clinicaltrials.gov attests that this investigation is actively looking for participants, having originally been posted on December 1st 2021 and last updated July 18th 2022. Ninety individuals are currently being accepted at a single medical centre."
Answered by AI
Are there vacancies available for participants in this investigation?
"According to clinicaltrials.gov, the recruitment process for this medical study is ongoing and began on December 1st 2021. The information was last updated on July 18th 2022."
Answered by AI
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