The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract

Sponsor
Justin Spaulding (Other)
Overall Status
Recruiting
CT.gov ID
NCT05495555
Collaborator
Sengi (Other)
50
1
13
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: INTREPID® Hybrid tip

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

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
High IOP setting

Cataract removal with high IOP setting

Device: INTREPID® Hybrid tip
INTREPID® Hybrid tip for cataract removal

Low IOP setting

Cataract removal with low IOP setting

Device: INTREPID® Hybrid tip
INTREPID® Hybrid tip for cataract removal

Outcome Measures

Primary Outcome Measures

  1. Phaco time [Day 0 (surgical visit)]

  2. Aspiration time [Day 0 (surgical visit)]

  3. Fluid use [Day 0 (surgical visit)]

Secondary Outcome Measures

  1. Central corneal thickness [1 week postoperative]

Other Outcome Measures

  1. Questionnaire [1 day postoperative]

    Visual analog pain scale

  2. Cumulative dissipated energy [Day 0 (surgical visit)]

    This will measure the the amount of ultrasound energy used during cataract removal

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • PNS grade 3 or 4 cataract

  • 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

  • PNS grade 1 or 2 cataract

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cataract & Laser Institute Medford Oregon United States 97504

Sponsors and Collaborators

  • Justin Spaulding
  • Sengi

Investigators

  • Principal Investigator: Justin Spaulding, DO, Cataract & Laser Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Justin Spaulding, Principal Investigator, Cataract and Laser Institute of Southern Oregon
ClinicalTrials.gov Identifier:
NCT05495555
Other Study ID Numbers:
  • JS-22-001
First Posted:
Aug 10, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022