The Evaluation of Balanced Salt Solution During Cataract Surgery (NCT05853978) | Clinical Trial Compass
CompletedPhase 4
The Evaluation of Balanced Salt Solution During Cataract Surgery
United States26 participantsStarted 2023-04-17
Plain-language 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.
Who can participate
Age range22 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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
. 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.