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The Evaluation of Balanced Salt Solution During Cataract Surgery

Primary Purpose

Fuchs Dystrophy, Cataract

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
BSS Plus
BSS
Sponsored by
Adam Fedyk, MD, FACS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fuchs Dystrophy focused on measuring Fuchs Corneal Endothelial Dystrophy, Nuclear Sclerosis, Cataract Surgery, Paired Eye, ARF-23-001

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • St. Louis Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BSS Plus

BSS

Arm Description

Outcomes

Primary Outcome Measures

Central Corneal Thickness (CCT)
Changes in central corneal thickness following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution

Secondary Outcome Measures

Intraoperative Grading of Corneal Edema
Intraoperative grading of corneal edema during cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.
Number of Intraocular Irrigating Solution Drops Used
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.

Full Information

First Posted
May 2, 2023
Last Updated
May 11, 2023
Sponsor
Adam Fedyk, MD, FACS
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05853978
Brief Title
The Evaluation of Balanced Salt Solution During Cataract Surgery
Official Title
The Evaluation of Balanced Salt Solution During Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adam Fedyk, MD, FACS
Collaborators
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs Dystrophy, Cataract
Keywords
Fuchs Corneal Endothelial Dystrophy, Nuclear Sclerosis, Cataract Surgery, Paired Eye, ARF-23-001

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BSS Plus
Arm Type
Experimental
Arm Title
BSS
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BSS Plus
Intervention Description
BSS PLUS® Sterile Intraocular Irrigating Solution (balanced salt solution enriched with bicarbonate, dextrose, and glutathione)
Intervention Type
Drug
Intervention Name(s)
BSS
Intervention Description
BSS® Sterile Irrigating Solution (balanced salt solution)
Primary Outcome Measure Information:
Title
Central Corneal Thickness (CCT)
Description
Changes in central corneal thickness following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution
Time Frame
Postoperative: Day 1
Secondary Outcome Measure Information:
Title
Intraoperative Grading of Corneal Edema
Description
Intraoperative grading of corneal edema during cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.
Time Frame
Day 0
Title
Number of Intraocular Irrigating Solution Drops Used
Description
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.
Time Frame
Day 0
Other Pre-specified Outcome Measures:
Title
Corneal Surface Keratopathy and Conjunctival Staining
Description
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.
Time Frame
Postoperative: Day 1 and Week 1
Title
Conjunctival Injection
Description
Changes in conjunctival injection following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.
Time Frame
Postoperative: Day 1 and Week 1
Title
Ocular Comfort Index (OCI)
Description
Assessment of Ocular Comfort Index (OCI) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.
Time Frame
Postoperative: Day 1 and Week 1
Title
Best Corrected Visual Acuity (BCVA)
Description
Best Corrected Visual Acuity (BCVA) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.
Time Frame
Postoperative: Month 1
Title
Endothelial Cell Density (ECD)
Description
Endothelial Cell Density (ECD) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution.
Time Frame
Postoperative: Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Fedyk, MD, FACS
Phone
314-974-7699
Email
adam.fedyk@stlouis-eye.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Carpenter
Phone
314-254-3818
Email
acarpenter@stlouis-eye.com
Facility Information:
Facility Name
St. Louis Eye Institute
City
Town And Country
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Fedyk, MD, FACS
Phone
314-974-7699
Email
adam.fedyk@stlouis-eye.com
First Name & Middle Initial & Last Name & Degree
Abigail Carpenter
Phone
314-254-3818
Email
acarpenter@stlouis-eye.com
First Name & Middle Initial & Last Name & Degree
Adam Fedyk, MD, FACS

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Evaluation of Balanced Salt Solution During Cataract Surgery

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