This Clinical Trial Compares Two Phacoemulsification Systems Used in a Bilateral Cataract Surgery Subjects in Order to Study CDE and Ultrasound Time During Cataract Removal

Nicole Fram M.D.

Status: Enrolling

Conditions: Nuclear Sclerosis of the Lens; Phacoemulsification Cataract Surgery; Cataract Bilateral

Treatments: Device: Cataract extraction with phacoemulsification comparing two systems

Study type: Interventional

Funder types: Other

Identifiers

NCT07468877

AVC-008

1405359 (Other Identifier)

Details and patient eligibility

About

This clinical trial compares two phacoemulsification systems used in a bilateral cataract surgery subjects, in order to study CDE and Ultrasound time during cataract removal

Full description

Unity and Centurion are two phacoemulsification systems routinely used during cataract surgery to assist the surgeon in removing the cataractous lens from the eye. This clinical trial aims to compare the performance of Unity versus Centurion during standard cataract surgery.

The primary objective of this study is to explore CDE and Ultrasound time during cataract extraction compared to Centurion.

This study will enroll 30 subjects (60 eyes) diagnosed with Nuclear Sclerosis cataract who require cataract surgery with intraocular lens implantation in both eyes.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy patients 18 years or older undergoing uncomplicated sequential bilateral cataract surgery with phacoemulsification and IOL implantation
• Expected to undergo sequential cataract surgery in both eyes
• Must have bilateral nuclear sclerosis cataracts classified using LOCS III as grade 3 or above (see appendix III)
• Both eyes will be operated on by the same surgeon
• Have the ability to consent for study and procedure planned

Exclusion criteria

• Patients under 18 years of age.
• Complex cataract cases involving zonulopathy (e.g., pseudoexfoliation syndrome, traumatic zonular weakness) that may require use of zonular support devices during surgery (e.g. capsular hooks) and/or implantation of capsular tension rings or other zonular support devices, and in the investigator's judgment, may interfere with the surgical procedure or study outcome measures.
• Require mechanical pupil expanding devices (e.g., iris hooks, Malyugin rings, etc.)
• Undergoing femtosecond laser-assisted lens fragmentation.
• Surgical complications, in the opinion of the investigator, occurring either intraoperatively or postoperatively (including capsule tears, iris trauma, or decentered intraocular lens) and not attributable to the study device or study design.
• Prior ocular surgery (including intraocular, oculoplastic, corneal or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment, if it interferes with the outcome measures of this study.
• Presence of endothelial cell dystrophies and/or corneal comorbidities.
• History of intraocular inflammation (e.g., uveitis, iritis).
• History of retinal edema or presence of a clinically significant epiretinal membrane that, in the investigator's clinical judgment, may interfere with the outcome measures of this study.
• History of retinal surgery (e.g.retinal detachment repair, membrane peel) involving vitrectomy.
• Dense brunescent cataract that in the investigator's clinical judgment, may interfere with the outcome measures of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Unity VCS/CS with 4D Phaco Handpiece

Active Comparator group

Description:

Patients are generally randomized to undergo surgery with Unity VCS/CS system with 4D phacoemulsification on one of there eyes

Treatment:

Device: Cataract extraction with phacoemulsification comparing two systems

Device: Cataract extraction with phacoemulsification comparing two systems

Centurion vision system with OZil Handpiece

Active Comparator group

Description:

Patients are generally randomized to undergo surgery with Centurion system with OZil technology phacoemulsification on one of there eyes

Treatment:

Device: Cataract extraction with phacoemulsification comparing two systems

Device: Cataract extraction with phacoemulsification comparing two systems