An observational study in Cataract, sponsored by Cataract and Laser Institute of Southern Oregon. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Cataract and Laser Institute of Southern Oregon · Observational
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 51 is below the median of 81 across 484 observational studies indexed under Cataract.
Browse Cataract studies →Cataract and Laser Institute of Southern Oregon is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
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.
Cataract removal with high IOP setting
Device: INTREPID® Hybrid tip
Cataract removal with low IOP setting
Device: INTREPID® Hybrid tip
INTREPID® Hybrid tip for cataract removal
Phaco Time
Time frame: Day 0 (surgical visit)
Aspiration Time
Time frame: Day 0 (surgical visit)
Fluid Use
Time frame: Day 0 (surgical visit)
Central Corneal Thickness Change From Baseline
Time frame: baseline and 1 week postoperative
Cumulative Dissipated Energy
This will measure the the amount of ultrasound energy used during cataract removal
Time frame: Day 0 (surgical visit)
| Milestone | High IOP Setting | Low IOP Setting |
|---|---|---|
| Started | 51 | 51 |
| Completed | 51 | 51 |
| Not completed | 0 | 0 |
| seconds | High IOP Setting | Low IOP Setting |
|---|---|---|
| Phaco Time | 41.6 ± 10 | 41.8 ± 10.2 |
| seconds | High IOP Setting | Low IOP Setting |
|---|---|---|
| Aspiration Time | 101.7 ± 27.2 | 106.7 ± 25.3 |
| mL | High IOP Setting | Low IOP Setting |
|---|---|---|
| Fluid Use | 41.6 ± 9.0 | 40.2 ± 7.8 |
| µm | High IOP Setting | Low IOP Setting |
|---|---|---|
| Central Corneal Thickness Change From Baseline | 5.4 ± 5.1 | 8.1 ± 8.9 |
This will measure the the amount of ultrasound energy used during cataract removal
| µJ | High IOP Setting | Low IOP Setting |
|---|---|---|
| Cumulative Dissipated Energy | 8.7 ± 3.1 | 8.6 ± 3.4 |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High IOP Setting | 0/51 (0%) | 0/51 (0%) | 3/51 (5.9%) |
| Low IOP Setting | 0/51 (0%) | 0/51 (0%) | 3/51 (5.9%) |
| Event | High IOP Setting | Low IOP Setting |
|---|---|---|
| Elevated IOPEye disorders | 3/51 | 3/51 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 75.8 ± 6.7 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 31 |
| Male | 20 |
| Race and Ethnicity Not Collected(Participants) | All Participants |
|---|
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 51 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Cataract and Laser Institute of Southern Oregon