The Evaluation of Balanced Salt Solution During Cataract Surgery

Study Overview
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Brief Summary
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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.

Official Title
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The Evaluation of Balanced Salt Solution During Cataract Surgery

Conditions
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Fuchs Dystrophy, Cataract

Intervention / Treatment
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* Drug: BSS Plus
* Drug: BSS


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BSS Plus<br> | Drug: BSS Plus<br>* BSS PLUS® Sterile Intraocular Irrigating Solution (balanced salt solution enriched with bicarbonate, dextrose, and glutathione)<br>|
| Active Comparator: BSS<br> | Drug: BSS<br>* BSS® Sterile Irrigating Solution (balanced salt solution)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Corneal Thickness (CCT) | Changes in central corneal thickness following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution | Postoperative: Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Grading of Corneal Edema | Intraoperative grading of corneal edema during cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution. | Day 0 | 
| Number of Intraocular Irrigating Solution Drops Used | Number of BSS PLUS® Sterile Intraocular Irrigating Solution drops used during cataract surgery to rewet corneal surface and maintain clarity, as compared to BSS® Sterile Irrigating Solution. | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fuchs Corneal Endothelial Dystrophy, Nuclear Sclerosis, Cataract Surgery, Paired Eye, ARF-23-001