Balanced Salt Solution for Cataract Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two different salt solutions, Balanced Salt Solution (BSS) and BSS Plus, used during cataract surgery to determine which promotes better eye health afterward. The focus is on patients with cataracts and Fuch's Dystrophy, a condition affecting the cornea. Suitable participants have cataracts in both eyes and corneal issues like Fuch's Dystrophy but remain in stable health, with conditions such as controlled diabetes or high blood pressure. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, allowing researchers to understand its benefits for more patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have controlled type II diabetes and hypertension, which suggests you may continue medications for these conditions if they are well-managed.
What is the safety track record for these treatments?
Research has shown that BSS PLUS® Sterile Intraocular Irrigating Solution is safe for use in eye surgeries. Studies have found it to be well-tolerated during procedures like cataract surgery. For example, one study found that most patients completed the trial without any problems, and doctors rated it highly for safety. Additionally, FDA approval for use in other eye surgeries further supports its safety.
BSS® Sterile Irrigating Solution is commonly used in many eye surgeries, indicating general safety. Although specific data on side effects is not provided, its widespread use suggests it is well-tolerated. Both solutions are designed to be gentle on the eye, reducing the risk of irritation or harm.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about BSS Plus for cataract surgery because it enhances the standard Balanced Salt Solution (BSS) by adding nutrients that help maintain corneal health. Unlike the typical BSS, which is mainly used to keep the eye hydrated during surgery, BSS Plus includes additional components like bicarbonate, dextrose, and glutathione. These extras aim to better protect the eye's cells during the procedure, potentially leading to improved outcomes and faster recovery for patients.
What evidence suggests that this trial's treatments could be effective for cataract surgery?
Research has shown that BSS PLUS® Sterile Intraocular Irrigating Solution, a treatment in this trial, may improve cataract surgery outcomes. Studies have found that it maintains corneal cell health better than the standard BSS® solution, another treatment arm in this trial. For instance, one study found that BSS Plus more effectively preserved corneal cell size. Another study reported similar benefits for visual clarity after cataract surgery. Overall, BSS Plus appears to support better corneal recovery, which is crucial for clearer vision post-surgery.12467
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cataract surgery using either BSS PLUS® or BSS® Sterile Irrigating Solution
Follow-up
Participants are monitored for corneal outcomes and other ocular measures post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- BSS
- BSS Plus
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adam Fedyk, MD, FACS
Lead Sponsor
Alcon Research
Industry Sponsor
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