The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract
1 other identifier
observational
51
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2022
CompletedStudy Start
First participant enrolled
August 3, 2022
CompletedFirst Posted
Study publicly available on registry
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2024
CompletedResults Posted
Study results publicly available
March 11, 2025
CompletedMarch 11, 2025
February 1, 2025
1.5 years
August 1, 2022
January 15, 2025
February 19, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Phaco Time
Day 0 (surgical visit)
Aspiration Time
Day 0 (surgical visit)
Fluid Use
Day 0 (surgical visit)
Secondary Outcomes (1)
Central Corneal Thickness Change From Baseline
baseline and 1 week postoperative
Other Outcomes (1)
Cumulative Dissipated Energy
Day 0 (surgical visit)
Study Arms (2)
High IOP setting
Cataract removal with high IOP setting
Low IOP setting
Cataract removal with low IOP setting
Interventions
Eligibility Criteria
Eligible test subjects will be 50 years of age or older and who are eligible to undergo sequential bilateral uncomplicated cataract surgery.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cataract and Laser Institute of Southern Oregonlead
- Sengicollaborator
Study Sites (1)
Cataract & Laser Institute
Medford, Oregon, 97504, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Justin Spaulding
- Organization
- Cataract & Laser Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Justin Spaulding, DO
Cataract & Laser Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2022
First Posted
August 10, 2022
Study Start
August 3, 2022
Primary Completion
February 7, 2024
Study Completion
February 7, 2024
Last Updated
March 11, 2025
Results First Posted
March 11, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share