CataractNCT07176416
Effective Phaco Time and Endothelial Cell Loss When Using Veritas
An observational study of Cataract, run by Aloha Vision Consultants at 1 site in United States.
Trial summary
This study is a single center, prospective study of cumulative dissipated energy and endothelial cells loss per phacoemulsification procedure after successful cataract surgery. Subjects will be assessed 3 months postoperatively at a single visit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- What is being tested?
- Veritas Vision System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2025to 1 Oct 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible test subjects will be adults who are candidates for age-related cataract surgery with IOL implantation.
Who may be able to join
- Adult patients undergoing age-related cataract surgery.
- Planned use of the Catalys Precision Laser System.
- Planned implantation of TECNIS intraocular lenses (IOLs).
Who cannot join
- Moderate-severe any disease state (deemed by the surgeon) that could increase risk of complicated cataract surgery (ie, pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, and prior refractive surgery).
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
Aloha Vision Consultants
‘Aiea, Hawaii, 96701
Alana K Dunn, 808-688-6898, avc.alanad@gmail.com
Carlton Yuen, MD
About this study
Official title: Assessment of Effective Phaco Time and Endothelial Cell Loss When Using a Novel Dual Mode Phacoemulsification System
This study is a single center, prospective study of cumulative dissipated energy and endothelial cells loss per phacoemulsification procedure after successful cataract surgery. Subjects will be assessed 3 months postoperatively at a single visit. Clinical evaluations will include central corneal thickness, specular microscopy, as well as measurement of visual acuities at distance.
- Conditions
- Cataract
- Being tested
- Veritas Vision System
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veritas Vision SystemDevice
Veritas Vision System
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective phaco time per phacoemulsification procedure
Measured: Surgery (Day 0)
Secondary outcomes (4)
Endothelial cell loss
Measured: 1 monthspostoperatively
Total case time
total case time per procedure
Measured: Surgery (Day 0)
Total phaco time
total phaco time per procedure
Measured: Surgery (Day 0)
Total volume used
Total volume used per procedure
Measured: Surgery (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start3 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aloha Vision Consultants
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Carlton Yuen, MD, Principal investigator, Aloha Vision Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176416
- Sponsor's protocol ID
- CY-25-01
- Status last verified
- Oct 2025
- First submitted
- 9 Sep 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Effective Phaco Time and Endothelial Cell Loss When Using a Novel Dual Mode Phacoemulsification System
- ClinicalTrials.gov ID
- NCT07176416
- Acronym / sponsor ID
- CY-25-01
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aloha Vision ConsultantsUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Sep 2025 (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 study is a single center, prospective study of cumulative dissipated energy and endothelial cells loss per phacoemulsification procedure after successful cataract surgery. Subjects will be assessed 3 months postoperatively at a single visit. Clinical evaluations will include central corneal thickness, specular microscopy, as well as measurement of visual acuities at distance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible test subjects will be adults who are candidates for age-related cataract surgery with IOL implantation.
Key inclusion criteria (3 listed)
- Adult patients undergoing age-related cataract surgery.
- Planned use of the Catalys Precision Laser System.
- Planned implantation of TECNIS intraocular lenses (IOLs).
Key exclusion criteria (1 listed)
- Moderate-severe any disease state (deemed by the surgeon) that could increase risk of complicated cataract surgery (ie, pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, and prior refractive surgery).
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 |
|---|---|---|
| Veritas Vision SystemVeritas Vision System | Device | – |
Primary outcome
Effective phaco time per phacoemulsification procedure
Time frame: Surgery (Day 0)
4 secondary outcomes
Endothelial cell loss
Time frame: 1 monthspostoperatively
Total case time
Time frame: Surgery (Day 0)
Total phaco time
Time frame: Surgery (Day 0)
Total volume used
Time frame: Surgery (Day 0)
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 9 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Carlton Yuen, MD principal investigator
Aloha Vision Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Aloha Vision Consultants 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 3 inclusion and 1 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 9 Oct 2025. 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 Alana K Dunn (808-688-6898, avc.alanad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective phaco time per phacoemulsification procedure (time frame: Surgery (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2025.