Balanced Salt Solution for Cataract Surgery

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Adam Fedyk, MD, FACS

No Placebo Group

Prior Safety Data

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

+3 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: BSS PlusExperimental Treatment1 Intervention

Group II: BSSActive Control1 Intervention