Balanced Salt Solution for Cataract Surgery

Overseen By Abigail Carpenter

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Adam Fedyk, MD, FACS

Disqualifiers: Severe dry eye, Retinal pathologies, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

27 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 22 with bilateral visually significant cataracts and Fuchs' Dystrophy, which affects the cornea. Participants should be generally healthy but can have controlled diabetes or hypertension. They must understand and sign consent, attend all post-op visits, and if female of childbearing age, use birth control during the study.

Inclusion Criteria

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

nonconfluent and confluent guttata; and/or CCT > 580 microns.

Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension

Treatment Details

Interventions

• BSS
• BSS Plus

Trial Overview The study compares two eye solutions used in cataract surgery: BSS PLUS® Sterile Intraocular Irrigating Solution versus BSS® Sterile Irrigating Solution. It aims to see if one leads to better outcomes for patients with compromised corneas due to conditions like Fuchs' Dystrophy.

Participant Groups

Group I: BSS Plus Experimental Treatment 1 Intervention

Group II: BSS Active Control 1 Intervention

Who Is Running the Clinical Trial?

Adam Fedyk, MD, FACS

Lead Sponsor

Trials

1

Recruited

30+

Alcon Research

Industry Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California