Comparing two cataract surgery techniques using advanced technology
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
NA · Centre hospitalier de l'Université de Montréal (CHUM) · NCT05119270
This study is testing if a new laser-assisted cataract surgery method is safer and more effective than the standard surgery technique for people needing cataract treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) (other) |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT05119270 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness and safety of femtosecond laser-assisted cataract surgery using the Active Sentry handpiece against standard phacoemulsification techniques. The femtosecond laser automates critical steps in the surgery, potentially reducing collateral damage and improving outcomes. The Active Sentry handpiece monitors intraocular pressure in real-time to enhance safety during the procedure. The study will evaluate differences in cumulative dissipated energy and corneal endothelial cell loss between these techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old undergoing uncomplicated cataract surgery.
Not a fit: Patients with a history of ocular surgery or concomitant ocular diseases other than cataract may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective cataract surgery options for patients.
How similar studies have performed: Other studies have shown promising results with femtosecond laser-assisted techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Montréal, Quebec
- Centre Hospitalier de l'Université de Montréal — Montréal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Georges Durr, MD, FRCSC — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Marie-Catherine Tessier, MSc
- Email: marie-catherine.tessier.chum@ssss.gouv.qc.ca
- Phone: 1-514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Corneal Endothelial Cell Loss, Cataract, Astigmatism, Centurion Vision System, Infiniti Vision System, cumulative dissipated energy, Phacoemulsification, Active Sentry handpiece