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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ postoperative: month 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative: month 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Central Corneal Thickness (CCT)
Secondary outcome measures
Intraoperative Grading of Corneal Edema
Number of Intraocular Irrigating Solution Drops Used
Other outcome measures
Best Corrected Visual Acuity (BCVA)
Conjunctival Injection
Corneal Surface Keratopathy and Conjunctival Staining
+2 moreTrial 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
704 Previous Clinical Trials
124,484 Total Patients Enrolled
116 Trials studying Cataract
20,705 Patients Enrolled for Cataract
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: BSS
- Group 2: BSS Plus
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks come with exposing oneself to BSS Plus?
"The safety of BSS Plus is rated a 3, as it has been approved by the Food and Drug Administration for use in Phase 4 clinical trials."
Answered by AI
Are there any open vacancies for this medical trial?
"The research posted on clinicaltrials.gov reveals that this particular trial is not presently looking for participants despite initially being published on May 1st 2023 and last edited two days later. However, there are a multitude of other studies actively recruiting patients right now - 138 in total."
Answered by AI
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