Nuclear Sclerosis of the LensCDENCT07468877
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
A study testing Cataract extraction with phacoemulsification comparing two systems in people with Nuclear Sclerosis of the Lens and Phacoemulsification Cataract Surgery, run by Nicole Fram M.D. at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nuclear Sclerosis of the Lens, Phacoemulsification Cataract Surgery, Cataract Bilateral
- What is being tested?
- Cataract extraction with phacoemulsification comparing two systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2026to 13 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Advanced Vision Care
Los Angeles, California, 90067
Orly Shiler, 8183919507, orlyjr@inorbit.com
Nicole R Fram, M.D.
About this study
Official title: Cumulative Dissipated Energy (CDE) and Total Phacoemulsification Energy (Joules) of Unity VCS/CS With 4D Phaco Compared to Centurion System With OZil
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
Read the 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.
- Being tested
- Cataract extraction with phacoemulsification comparing two systems
- Keywords
- Phacoemolsification, Unity VCS/CS, Centurion, Nuclear Sclerosis of the lens, Cataract
- Medical subject headings
- Cataract, Age-Related Nuclear, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract extraction with phacoemulsification comparing two systemsDevice
First arm: Phacoemulsification using UNITY VCS/CS system with UNITY 4D phaco handpiece
Cataract extraction with phacoemulsification comparing two systemsDevice
Second arm: Phacoemulsification using Centurion system with OZil technology
| Study group | Role | What they receive |
|---|---|---|
| Unity VCS/CS with 4D Phaco Handpiece | Active comparator | Patients are generally randomized to undergo surgery with Unity VCS/CS system with 4D phacoemulsification on one of there eyes Receives: Device: Cataract extraction with phacoemulsification comparing two systems |
| Centurion vision system with OZil Handpiece | Active comparator | Patients are generally randomized to undergo surgery with Centurion system with OZil technology phacoemulsification on one of there eyes Receives: Device: Cataract extraction with phacoemulsification comparing two systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Dissipated Energy
CDE is a measure of the total ultrasound energy delivered into the eye during phacoemulsification cataract surgery
Measured: Intraoperative
Secondary outcomes (1)
Total Ultrasound Time
The time it takes to emulsify the lens material during cataract surgery
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start13 Feb 2026
- Primary completion13 Feb 2027 (estimated)
- Study completion13 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nuclear Sclerosis of the LensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Contra-lateral eye design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicole Fram M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicole Fram M.D., Advanced Vision Care
- Investigators
- Nicole R Fram, M.D., Principal investigator, Advanced Vision Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468877
- Sponsor's protocol ID
- AVC-008
- Other IDs
- 1405359
- Acronym
- CDE
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: In part due to : risk of Re-identification and Informed Consent Limitations.
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.
PubMed 26316688
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cumulative Dissipated Energy (CDE) and Total Phacoemulsification Energy (Joules) of Unity VCS/CS With 4D Phaco Compared to Centurion System With OZil
- ClinicalTrials.gov ID
- NCT07468877
- Acronym / sponsor ID
- CDE / AVC-008
- Keywords
- Phacoemolsification, Unity VCS/CS, Centurion, Nuclear Sclerosis of the lens, Cataract
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nicole Fram M.D.University, hospital or other
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 13 Feb 2027 (estimated)
- Study completion
- 13 Feb 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Contra-lateral eye design
| Arm | Type | Receives |
|---|---|---|
| Unity VCS/CS with 4D Phaco Handpiece | Active comparator | Device: Cataract extraction with phacoemulsification comparing two systemsPatients are generally randomized to undergo surgery with Unity VCS/CS system with 4D phacoemulsification on one of there eyes |
| Centurion vision system with OZil Handpiece | Active comparator | Device: Cataract extraction with phacoemulsification comparing two systemsPatients are generally randomized to undergo surgery with Centurion system with OZil technology phacoemulsification on one of there eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract extraction with phacoemulsification comparing two systemsFirst arm: Phacoemulsification using UNITY VCS/CS system with UNITY 4D phaco handpiece | Device | Unity VCS/CS with 4D Phaco Handpiece |
| Cataract extraction with phacoemulsification comparing two systemsSecond arm: Phacoemulsification using Centurion system with OZil technology | Device | Centurion vision system with OZil Handpiece |
Primary outcome
Cumulative Dissipated Energy
Time frame: Intraoperative
CDE is a measure of the total ultrasound energy delivered into the eye during phacoemulsification cataract surgery
1 secondary outcome
Total Ultrasound Time
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 26316688Erratum: 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.
- Individual participant dataSharing planned: No. In part due to : risk of Re-identification and Informed Consent Limitations.
Related trials for Nuclear Sclerosis of the Lens
Not yet recruiting
The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage
Cataract and IOL Surgery, Cataract Surgery Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole R Fram, M.D. principal investigator
Advanced Vision Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract extraction with phacoemulsification comparing two systems in people with Nuclear Sclerosis of the Lens and Phacoemulsification Cataract Surgery, run by Nicole Fram M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Orly Shiler (3102291220, orlyjr@inorbit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Dissipated Energy (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07468877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.