The Evaluation of Balanced Salt Solution During Cataract Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Fuchs Dystrophy
• Intervention / Treatment: Drug: BSS Plus; Drug: BSS

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Adam Fedyk, MD, FACS; Phone Number: 314-974-7699; Email: adam.fedyk@stlouis-eye.com
• Study Contact Backup: Name: Abigail Carpenter; Phone Number: 314-254-3818; Email: acarpenter@stlouis-eye.com

Study Locations

• United States
  • Missouri
    • Town And Country, Missouri, United States, 63017
      • Recruiting
      • St. Louis Eye Institute
      • Contact: Adam Fedyk, MD, FACS; Phone Number: 314-974-7699; Email: adam.fedyk@stlouis-eye.com
      • Contact: Abigail Carpenter; Phone Number: 314-254-3818; Email: acarpenter@stlouis-eye.com
      • Principal Investigator: Adam Fedyk, MD, FACS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Adam Fedyk, MD, FACS
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Cataract Surgery; Nuclear Sclerosis; Fuchs Corneal Endothelial Dystrophy; Paired Eye; ARF-23-001
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Lens Diseases; Corneal Diseases; Corneal Dystrophies, Hereditary; Cataract; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: ARF-23-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes