The Evaluation of Balanced Salt Solution During Cataract Surgery

Cataract Clinical Trial

Official title:

The Evaluation of Balanced Salt Solution During Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853978
• Other study ID #: ARF-23-001
• Status: Recruiting
• Phase: Phase 4
• Start date: May 2023
• Est. completion date: January 2024

Study information

• Verified date: May 2023
• Source: St. Louis Eye Institute
• Contact: Adam Fedyk, MD, FACS
• Phone: 314-974-7699
• Email: adam.fedyk[@]stlouis-eye.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria

1. Adults, 22 years of age or older, with bilateral visually significant cataracts.

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

1. Planned implantation of multifocal intraocular lenses.

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.

Related Conditions & MeSH terms

• Cataract
• Fuchs Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United States	St. Louis Eye Institute	Town And Country	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Adam Fedyk, MD, FACS	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Corneal Surface Keratopathy and Conjunctival Staining	Changes in corneal surface keratopathy and conjunctival staining following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.	Postoperative: Day 1 and Week 1
Other	Conjunctival Injection	Changes in conjunctival injection following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.	Postoperative: Day 1 and Week 1
Other	Ocular Comfort Index (OCI)	Assessment of Ocular Comfort Index (OCI) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.	Postoperative: Day 1 and Week 1
Other	Best Corrected Visual Acuity (BCVA)	Best Corrected Visual Acuity (BCVA) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.	Postoperative: Month 1
Other	Endothelial Cell Density (ECD)	Endothelial Cell Density (ECD) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.	Postoperative: Month 1
Primary	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	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
Secondary	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