Balanced Salt Solution for Cataract Surgery

No longer recruiting at 1 trial location
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 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.12345

Why 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

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
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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

Citations

Balanced Salt Solution-Assisted Intraocular Lens ...The study included 52 eyes of 40 patients (25 female, 15 male) who underwent uneventful phacoemulsification cataract surgery with BSS-assisted IOL implantation ...
The Evaluation of Balanced Salt Solution During Cataract ...Best Corrected Visual Acuity (BCVA) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating ...
Intraocular Irrigating Solutions: A Randomized Clinical Trial ...Results: Fifty-eight subjects (91%) completed the 2-month study. Change in cell size for the BSS Plus group (n = 28) (mean ± standard error, 29.4 ± 12.3 μm2) ...
Comparison of corneal changes after phacoemulsification ...The results of the current study show, as clearly plotted in figure 1, that BSS Plus is similar to Lactated Ringer's with respect to the clinical parameters ( ...
Intraocular Irrigating Solutions. A Clinical Study of BSS...Both solutions showed comparable effects on postoperative corneal endothelial cell density and corneal epithelial changes intraoperatively. BSS fortified has ...
BSS PLUS® STERILE IRRIGATING SOLUTION (balanced salt ...Human in vivo studies have demonstrated BSS PLUS solution to be safe and effective when used during surgical procedures such as pars plan vitrectomy, ...
BSS Plus Ratings & Reviews by Doctors | Uses & Side EffectsBSS Plus is broadly recognized as a safe and effective irrigating solution for ocular surgeries, earning a strong safety rating of 4.3 from physicians and ...
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