NCT05853978
Completed
Phase 4
The Evaluation of Balanced Salt Solution During Cataract Surgery
Adam Fedyk, MD, FACS1 site in 1 country26 target enrollmentStarted: April 17, 2023Last updated:
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Adam Fedyk, MD, FACS
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Central Corneal Thickness (CCT)
Overview
Brief Summary
This study aims to identify if the use of BSS PLUS® Sterile Intraocular Irrigating Solution as an irrigation solution leads to improved corneal outcomes vs BSS® Sterile Irrigating Solution in more compromised corneas.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BSS Plus
Experimental
Intervention: BSS Plus (Drug)
BSS
Active Comparator
Intervention: BSS (Drug)
Outcomes
Primary Outcomes
Central Corneal Thickness (CCT)
Time Frame: Postoperative: Day 1
Changes in central corneal thickness following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution
Secondary Outcomes
- Intraoperative Grading of Corneal Edema(Day 0)
- Number of Intraocular Irrigating Solution Drops Used(Day 0)
Investigators
Adam Fedyk, MD, FACS
Owner
St. Louis Eye Institute
Study Sites (1)
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