The Evaluation of Balanced Salt Solution During Cataract Surgery

Phase 4

Active, not recruiting

• Conditions: Cataract; Fuchs Dystrophy
• Interventions: Drug: BSS Plus; Drug: BSS

• Registration Number: NCT05853978
• Lead Sponsor: Adam Fedyk, MD, FACS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-17
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-02
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BSS Plus	BSS Plus	-
BSS	BSS	-

Primary Outcome Measures

Name	Time	Method
Central Corneal Thickness (CCT)	Postoperative: Day 1	Changes in central corneal thickness following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution

Secondary Outcome Measures

Name	Time	Method
Intraoperative Grading of Corneal Edema	Day 0	Intraoperative grading of corneal edema during cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.
Number of Intraocular Irrigating Solution Drops Used	Day 0	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.

Trial Locations

Locations (1)

St. Louis Eye Institute; 🇺🇸 Town And Country, Missouri, United States