The Evaluation of Balanced Salt Solution During Cataract Surgery
Completed · Phase 4
Conditions studied: Fuchs Dystrophy, Cataract
In brief
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.
Key facts
- Study ID
- NCT05853978
- Run by
- Adam Fedyk, MD, FACS
- People needed
- 26
- Starts
- 2023-04-17
- Expected to finish
- 2025-03-31
- Last updated by the study team
- 2025-07-03
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adults, 22 years of age or older, with bilateral visually significant cataracts.
- Subjects with Fuch's Dystrophy that present with:
- nonconfluent and confluent guttata; and/or
- CCT > 580 microns.
- Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension
- Ability to comprehend and sign a statement of informed consent.
- Ability to complete all required postoperative visits.
- Willingness to use at least one medically acceptable form of birth control throughout the duration of study participation. (for female subjects of childbearing potential only).
You may not qualify if…
- Planned implantation of multifocal intraocular lenses.
- Planned secondary procedure(s) to occur in conjunction with cataract surgery (i.e., goniotomy)
- History of severe dry eye.
- Retinal and retinal vascular pathologies, age-related macular degeneration
- Uncontrolled systematic diseases, including: hypertension, diabetes, systemic cardiovascular diseases and hematological diseases.
- Autoimmune disease such as rheumatoid arthritis.
- Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Where it is running
- St. Louis Eye Institute — Town and Country, Missouri, United States
Full record on ClinicalTrials.gov
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