FLACS vs Standard Phacoemulsification for Cataracts

Recruiting in Palo Alto (17 mi)

Overseen byGeorges Durr, MD, FRCSC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Georges Durr, MD, FRCSC

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

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.

Inclusion Criteria

Ability to provide informed consent;

I am having a straightforward cataract surgery with lens replacement.

Ability to be followed for the entire duration of the study.

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Exclusion Criteria

I have eye conditions other than cataracts.

I have had eye surgery in the past.

I cannot commit to the full duration of the study.

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Treatment Details

Interventions

Femtosecond laser assisted cataract surgery with Active Sentry handpiece (Device)
Standard phacoemulsification with the Active Sentry handpiece (Procedure)
Standard phacoemulsification with the OZil handpiece (Procedure)

Trial OverviewThe 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.

Participant Groups

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