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Completed

NCT Number: NCT05853978

The Evaluation of Balanced Salt Solution During Cataract Surgery

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.

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Key information

Conditions

Fuchs Dystrophy Cataract Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Louis Eye Institute

Town and Country, Missouri, 63017, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults, 22 years of age or older, with bilateral visually significant cataracts.
  • Subjects with Fuch's Dystrophy that present with:
  • nonconfluent and confluent guttata; and/or
  • CCT > 580 microns.
  • Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension
  • Ability to comprehend and sign a statement of informed consent.
  • Ability to complete all required postoperative visits.
  • Willingness to use at least one medically acceptable form of birth control throughout the duration of study participation. (for female subjects of childbearing potential only).

Exclusion criteria

  • Planned implantation of multifocal intraocular lenses.
  • Planned secondary procedure(s) to occur in conjunction with cataract surgery (i.e., goniotomy)
  • History of severe dry eye.
  • Retinal and retinal vascular pathologies, age-related macular degeneration
  • Uncontrolled systematic diseases, including: hypertension, diabetes, systemic cardiovascular diseases and hematological diseases.
  • Autoimmune disease such as rheumatoid arthritis.
  • Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

Treatment and study plan

BSS Plus

Drug

BSS PLUS® Sterile Intraocular Irrigating Solution (balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

BSS

Drug

BSS® Sterile Irrigating Solution (balanced salt solution)

Primary outcomes

  1. Central Corneal Thickness (CCT)

    Time frame: Postoperative: Day 1

    Changes in central corneal thickness following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution

Secondary outcomes

  1. Intraoperative Grading of Corneal Edema

    Time frame: Day 0

    Intraoperative grading of corneal edema during cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.

  2. Number of Intraocular Irrigating Solution Drops Used

    Time frame: Day 0

    Number of BSS PLUS® Sterile Intraocular Irrigating Solution drops used during cataract surgery to rewet corneal surface and maintain clarity, as compared to BSS® Sterile Irrigating Solution.

Other outcomes

  1. Corneal Surface Keratopathy and Conjunctival Staining

    Time frame: Postoperative: Day 1 and Week 1

    Changes in corneal surface keratopathy and conjunctival staining following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.

  2. Conjunctival Injection

    Time frame: Postoperative: Day 1 and Week 1

    Changes in conjunctival injection following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.

  3. Ocular Comfort Index (OCI)

    Time frame: Postoperative: Day 1 and Week 1

    Assessment of Ocular Comfort Index (OCI) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.

  4. Best Corrected Visual Acuity (BCVA)

    Time frame: Postoperative: Month 1

    Best Corrected Visual Acuity (BCVA) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.

  5. Endothelial Cell Density (ECD)

    Time frame: Postoperative: Month 1

    Endothelial Cell Density (ECD) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.

Sponsors and collaborators

Lead sponsor

Adam Fedyk, MD, FACS

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 11, 2023
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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