CataractNCT05868772
What is the Efficiency When Comparing Active Sentry at Low IOP vs Ozil at High IOP?
An observational study of Cataract, run by Cataract and Laser Institute of Southern Oregon at 1 site in United States.
Trial summary
The objective is to assess the efficiency of the Active Sentry handpiece at low intraocular pressure (IOP) compared with the Ozil at high IOP. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Active Sentry Handpiece and Ozil Handpiece
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to 19 Apr 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible test subjects will be 50 years of age or older and who are eligible to undergo sequential bilateral uncomplicated cataract surgery.
Who may be able to join
- Subjects are eligible for the study if they meet the following criteria:
- Note: Ocular criteria must be met in both eyes.
- Be eligible to undergo sequential bilateral uncomplicated cataract surgery.
- Undergo uneventful cataract surgery.
- Gender: Males and Females.
- Both eyes must have same grade of cataract.
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and other study procedures.
Who cannot join
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Patient under 50 years of age.
- Unable to complete sequential bilateral cataract surgery in both eyes by the same surgeon (JS).
- Patient cataract surgery complicated by posterior capsular tear.
- Any disease state deemed by PI that increases risk of complicated cataract surgery (ie Pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, RA, prior refractive surgery, etc).
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to assess the efficiency of the Active Sentry handpiece at low intraocular pressure (IOP) compared with the Ozil at high IOP.
Read the detailed description
This study is a single site, single-masked, randomized, prospective, contralateral eye study of the efficiency of the Active Sentry handpiece at low IOP compared with the Ozil at high IOP.
- Conditions
- Cataract
- Being tested
- Active Sentry Handpiece, Ozil Handpiece
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Sentry HandpieceDevice
With low IOP settings
Ozil HandpieceDevice
With high IOP settings.
| Study group | Role | What they receive |
|---|---|---|
| Active Sentry Handpiece | At low IOP settings Receives: Device: Active Sentry Handpiece | |
| Ozil Handpiece | At high IOP settings Receives: Device: Ozil Handpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Aspiration Time
Measured: Day of surgery (Day 0)
Secondary outcomes (3)
Total Fluid Volume
Measured: Day of surgery (Day 0)
Total Phaco Time
Measured: Day of surgery (Day 0)
Central Corneal Thickness
Measured: 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start16 May 2023
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cataract and Laser Institute of Southern Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Justin Spaulding, DO, Principal investigator, Cataract and Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868772
- Sponsor's protocol ID
- JS-23-01
- Status last verified
- Apr 2025
- First submitted
- 3 May 2023
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Efficiency When Comparing Active Sentry at Low IOP vs Ozil at High IOP?
- ClinicalTrials.gov ID
- NCT05868772
- Acronym / sponsor ID
- JS-23-01
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cataract and Laser Institute of Southern OregonUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 16 May 2023 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Posted 17 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to assess the efficiency of the Active Sentry handpiece at low intraocular pressure (IOP) compared with the Ozil at high IOP.
Detailed description
This study is a single site, single-masked, randomized, prospective, contralateral eye study of the efficiency of the Active Sentry handpiece at low IOP compared with the Ozil at high IOP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Sentry Handpiece | – | Device: Active Sentry HandpieceAt low IOP settings |
| Ozil Handpiece | – | Device: Ozil HandpieceAt high IOP settings |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible test subjects will be 50 years of age or older and who are eligible to undergo sequential bilateral uncomplicated cataract surgery.
Key inclusion criteria (8 listed)
- Note: Ocular criteria must be met in both eyes.
- Be eligible to undergo sequential bilateral uncomplicated cataract surgery.
- Undergo uneventful cataract surgery.
- Gender: Males and Females.
- Both eyes must have same grade of cataract.
Key exclusion criteria (7 listed)
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Patient under 50 years of age.
- Unable to complete sequential bilateral cataract surgery in both eyes by the same surgeon (JS).
- Patient cataract surgery complicated by posterior capsular tear.
- Any disease state deemed by PI that increases risk of complicated cataract surgery (ie Pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, RA, prior refractive surgery, etc).
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 |
|---|---|---|
| Active Sentry HandpieceWith low IOP settings | Device | Active Sentry Handpiece |
| Ozil HandpieceWith high IOP settings. | Device | Ozil Handpiece |
Primary outcome
Total Aspiration Time
Time frame: Day of surgery (Day 0)
3 secondary outcomes
Total Fluid Volume
Time frame: Day of surgery (Day 0)
Total Phaco Time
Time frame: Day of surgery (Day 0)
Central Corneal Thickness
Time frame: 1 week postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Justin Spaulding, DO principal investigator
Cataract and Laser Institute
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 Cataract and Laser Institute of Southern Oregon 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 17 Apr 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?
Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Aspiration Time (time frame: Day of 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 17 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.