26 Participants Needed

Balanced Salt Solution for Cataract Surgery

AF
AC
Overseen ByAbigail Carpenter
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Adam Fedyk, MD, FACS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract surgery using either BSS PLUS® or BSS® Sterile Irrigating Solution

Day 0
1 visit (in-person)

Follow-up

Participants are monitored for corneal outcomes and other ocular measures post-surgery

1 month
3 visits (in-person)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: BSS PlusExperimental Treatment1 Intervention
Group II: BSSActive Control1 Intervention

Find a Clinic Near You

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 profile image

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott profile image

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

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