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Recruiting NCT07468877

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

No phase Interventional Nuclear Sclerosis of the Lens Phacoemulsification Cataract Surgery Cataract Bilateral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cataract extraction with phacoemulsification comparing two systems, Cataract extraction with phacoemulsification comparing two systems.
Who it may be relevant to
Registry conditions: Nuclear Sclerosis of the Lens, Phacoemulsification Cataract Surgery, Cataract Bilateral. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Cumulative Dissipated Energy (CDE) and Total Phacoemulsification Energy (Joules) of Unity VCS/CS With 4D Phaco Compared to Centurion System With OZil

Overview

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

Detailed 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.

Interventions

  • Device Cataract extraction with phacoemulsification comparing two systems
    First arm: Phacoemulsification using UNITY VCS/CS system with UNITY 4D phaco handpiece
  • Device Cataract extraction with phacoemulsification comparing two systems
    Second arm: Phacoemulsification using Centurion system with OZil technology

Primary outcome measures

  • Cumulative Dissipated Energy [Time frame: Intraoperative]
Secondary outcome measures (1)
  • Total Ultrasound Time [Time frame: Intraoperative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Advanced Vision Care — Los Angeles

Publications

  • Erratum: Comparison of cumulative dissipated energy between the Infiniti and Centurion phacoemulsification systems [Corrigendum]. Clin Ophthalmol. 2015 Aug 19;9:1475. doi: 10.2147/OPTH.S93330. eCollection 2015. PMID 26316688

Identifiers

NCT: NCT07468877 · AVC-008 · 1405359

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗