The Evaluation of Balanced Salt Solution During Cataract Surgery

NCT05853978 | Completed Phase 4 FDA Drug

• 1 other identifier: ARF-23-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fuchs Dystrophy; Cataract

Keywords

Fuchs Corneal Endothelial Dystrophy; Nuclear Sclerosis; Cataract Surgery; Paired Eye; ARF-23-001

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intraoperative Grading of Corneal Edema

  Day 0

• Number of Intraocular Irrigating Solution Drops Used

  Day 0

Other Outcomes (5)

• Corneal Surface Keratopathy and Conjunctival Staining

  Postoperative: Day 1 and Week 1

• Conjunctival Injection

  Postoperative: Day 1 and Week 1

• Ocular Comfort Index (OCI)

  Postoperative: Day 1 and Week 1

Study Arms (2)

BSS Plus

EXPERIMENTAL

Drug: BSS Plus

BSS

ACTIVE COMPARATOR

Drug: BSS

Interventions

BSS Plus DRUG

BSS PLUS® Sterile Intraocular Irrigating Solution (balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

BSS Plus

BSS DRUG

BSS® Sterile Irrigating Solution (balanced salt solution)

BSS

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adam Fedyk, MD, FACS: lead
• Alcon Research: collaborator

Study Sites (1)

St. Louis Eye Institute

Town and Country, Missouri, 63017, United States

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Interventions

glutathione-bicarbonate-Ringer solution

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lens Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Owner

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 11, 2023
• Study Start: April 17, 2023
• Primary Completion: February 21, 2025
• Study Completion: March 31, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

US (1)