CataractNCT05495555
The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract
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 (as measured by phaco time, aspiration time, and fluid use) of the hybrid tip in removing cataract grade 3 \& 4 in high and low intraocular pressure (IOP) settings. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- INTREPID® Hybrid tip
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2022to 7 Feb 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
- No healthy volunteers
- 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.
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
- Grade 3 or 4 cataract (PNS or LOCS III)
- Undergo uneventful cataract surgery
- Gender: Males and Females.
- Age: 50 or older.
- 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.
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 (as measured by phaco time, aspiration time, and fluid use) of the hybrid tip in removing cataract grade 3 \& 4 in high and low intraocular pressure (IOP) settings.
Read the detailed description
This study is a Single site, single-masked, randomized, prospective, observational study of the efficiency of the hybrid tip in removing cataract grade 3 \& 4 in high and low intraocular pressure (IOP) settings. Subjects will be assessed pre-operatively, operatively and at 1 day and 1 week post-operatively. Clinical evaluations will include measurement of visual acuity, central corneal thickness, IOP, visual analog pain scale, and slit lamp examination.
- Conditions
- Cataract
- Being tested
- INTREPID® Hybrid tip
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTREPID® Hybrid tipDevice
INTREPID® Hybrid tip for cataract removal
| Study group | Role | What they receive |
|---|---|---|
| High IOP setting | Cataract removal with high IOP setting Receives: Device: INTREPID® Hybrid tip | |
| Low IOP setting | Cataract removal with low IOP setting Receives: Device: INTREPID® Hybrid tip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phaco Time
Measured: Day 0 (surgical visit)
Aspiration Time
Measured: Day 0 (surgical visit)
Fluid Use
Measured: Day 0 (surgical visit)
Secondary outcomes (1)
Central Corneal Thickness Change From Baseline
Measured: baseline and 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 posted10 Aug 2022
- Study start3 Aug 2022
- Primary completion7 Feb 2024
- Study completion7 Feb 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
- 51 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 & Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495555
- Sponsor's protocol ID
- JS-22-001
- Status last verified
- Feb 2025
- First submitted
- 1 Aug 2022
- Last updated
- 11 Mar 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract
- ClinicalTrials.gov ID
- NCT05495555
- Acronym / sponsor ID
- JS-22-001
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Cataract and Laser Institute of Southern OregonUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Posted 11 Mar 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 (as measured by phaco time, aspiration time, and fluid use) of the hybrid tip in removing cataract grade 3 \& 4 in high and low intraocular pressure (IOP) settings.
Detailed description
This study is a Single site, single-masked, randomized, prospective, observational study of the efficiency of the hybrid tip in removing cataract grade 3 \& 4 in high and low intraocular pressure (IOP) settings. Subjects will be assessed pre-operatively, operatively and at 1 day and 1 week post-operatively. Clinical evaluations will include measurement of visual acuity, central corneal thickness, IOP, visual analog pain scale, and slit lamp examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High IOP setting | – | Device: INTREPID® Hybrid tipCataract removal with high IOP setting |
| Low IOP setting | – | Device: INTREPID® Hybrid tipCataract removal with low IOP setting |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not 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.
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 |
|---|---|---|
| INTREPID® Hybrid tipINTREPID® Hybrid tip for cataract removal | Device | High IOP setting, Low IOP setting |
Primary outcome
Phaco Time
Time frame: Day 0 (surgical visit)
Aspiration Time
Time frame: Day 0 (surgical visit)
Fluid Use
Time frame: Day 0 (surgical visit)
1 secondary outcome
Central Corneal Thickness Change From Baseline
Time frame: baseline and 1 week postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 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 & 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?
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 11 Mar 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 11 Mar 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?
Phaco Time (time frame: Day 0 (surgical visit)). The study lists 3 primary outcomes in all. 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 11 Mar 2025.