The Evaluation of Balanced Salt Solution During Cataract Surgery
NCT ID: NCT05853978
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
26 participants
INTERVENTIONAL
2023-04-17
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
TRIPLE
Study Groups
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BSS Plus
BSS Plus
BSS PLUS® Sterile Intraocular Irrigating Solution (balanced salt solution enriched with bicarbonate, dextrose, and glutathione)
BSS
BSS
BSS® Sterile Irrigating Solution (balanced salt solution)
Interventions
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BSS Plus
BSS PLUS® Sterile Intraocular Irrigating Solution (balanced salt solution enriched with bicarbonate, dextrose, and glutathione)
BSS
BSS® Sterile Irrigating Solution (balanced salt solution)
Eligibility Criteria
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Inclusion Criteria
2. Subjects with Fuch's Dystrophy that present with:
1. nonconfluent and confluent guttata; and/or
2. CCT \> 580 microns.
3. Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension
4. Ability to comprehend and sign a statement of informed consent.
5. Ability to complete all required postoperative visits.
6. 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).
Exclusion Criteria
2. Planned secondary procedure(s) to occur in conjunction with cataract surgery (i.e., goniotomy)
3. History of severe dry eye.
4. Retinal and retinal vascular pathologies, age-related macular degeneration
5. Uncontrolled systematic diseases, including: hypertension, diabetes, systemic cardiovascular diseases and hematological diseases.
6. Autoimmune disease such as rheumatoid arthritis.
7. Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
22 Years
ALL
Yes
Sponsors
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Alcon Research
INDUSTRY
Adam Fedyk, MD, FACS
OTHER
Responsible Party
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Adam Fedyk, MD, FACS
Owner
Locations
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St. Louis Eye Institute
Town and Country, Missouri, United States
Countries
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Other Identifiers
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ARF-23-001
Identifier Type: -
Identifier Source: org_study_id
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