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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

ConditionsNuclear Sclerosis of the LensPhacoemulsification Cataract SurgeryCataract Bilateral
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNicole Fram M.D.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Cataract extraction with phacoemulsification comparing two systems

    Device

    First arm: Phacoemulsification using UNITY VCS/CS system with UNITY 4D phaco handpiece

  • Cataract extraction with phacoemulsification comparing two systems

    Device

    Second arm: Phacoemulsification using Centurion system with OZil technology

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Unity VCS/CS with 4D Phaco HandpieceActive comparator 1 intervention
Group B: Centurion vision system with OZil HandpieceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative Dissipated Energy

CDE is a measure of the total ultrasound energy delivered into the eye during phacoemulsification cataract surgery

Time frame
Intraoperative

Secondary outcomes

1

Total Ultrasound Time

The time it takes to emulsify the lens material during cataract surgery

Time frame
Intraoperative

Other outcomes

1

Total Aspiration Time

The total duration the surgeon spends removing lens material and cortical debris using the aspiration handpiece

Time frame
Intraoperative
2

Central Corneal Thickness

Onset and changes in corneal thickness after phacoemulsification performed by Unity vs Centurion Ozil, measured at the apex using Pentacam

Time frame
post op day 1
3

Anterior chamber inflammation

Onset and changes in AC inflammation after phacoemulsification performed by Unity vs Centurion Ozil, Assessed during slit-lamp examination using SUN criteria

Time frame
Post op day 1 and Post op day 7
4

Presence of Berger space

Onset and changes in Space between posterior capsule and vitreous body after phacoemulsification performed by Unity vs Centurion Ozil, measured by AS-OCT

Time frame
Post op day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicole Fram M.D.

Lead sponsor

Advanced Vision Care

Sponsor institution

Source ClinicalTrials.gov
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