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Sterile Irrigating Solution

Balanced Salt Solution for Cataract Surgery

Phase 4
Recruiting
Research Sponsored by Adam Fedyk, MD, FACS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative: month 1
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial tests if a new eye solution can improve corneal health in damaged eyes.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with intraocular irrigating solutions include irritation or inflammation of the eye, changes in vision, increased intraocular pressure or potential allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative: month 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative: month 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Central Corneal Thickness (CCT)
Secondary study objectives
Intraoperative Grading of Corneal Edema
Number of Intraocular Irrigating Solution Drops Used
Other study objectives
Best Corrected Visual Acuity (BCVA)
Conjunctival Injection
Corneal Surface Keratopathy and Conjunctival Staining
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BSS PlusExperimental Treatment1 Intervention
Group II: BSSActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BSS Plus
2006
Completed Phase 3
~760

Find a Location

Who is running the clinical trial?

Adam Fedyk, MD, FACSLead Sponsor
Alcon ResearchIndustry Sponsor
730 Previous Clinical Trials
129,154 Total Patients Enrolled
118 Trials studying Cataract
20,967 Patients Enrolled for Cataract

Media Library

BSS (Sterile Irrigating Solution) Clinical Trial Eligibility Overview. Trial Name: NCT05853978 — Phase 4
Cataract Research Study Groups: BSS, BSS Plus
Cataract Clinical Trial 2023: BSS Highlights & Side Effects. Trial Name: NCT05853978 — Phase 4
BSS (Sterile Irrigating Solution) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05853978 — Phase 4
~11 spots leftby Nov 2025
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