Fuchs DystrophyPhase 4NCT05853978
The Evaluation of Balanced Salt Solution During Cataract Surgery
A Phase 4 study testing BSS Plus and BSS in people with Fuchs Dystrophy and Cataract, run by Adam Fedyk, MD, FACS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fuchs Dystrophy, Cataract
- What is being tested?
- BSS Plus and BSS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 31 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Eye Institute
Town and Country, Missouri, 63017
About this study
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.
- Conditions
- Fuchs Dystrophy, Cataract
- Being tested
- BSS Plus, BSS
- Keywords
- Fuchs Corneal Endothelial Dystrophy, Nuclear Sclerosis, Cataract Surgery, Paired Eye, ARF-23-001
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSS PlusDrug
BSS PLUS® Sterile Intraocular Irrigating Solution (balanced salt solution enriched with bicarbonate, dextrose, and glutathione)
BSSDrug
BSS® Sterile Irrigating Solution (balanced salt solution)
| Study group | Role | What they receive |
|---|---|---|
| BSS Plus | Experimental | Not described Receives: Drug: BSS Plus |
| BSS | Active comparator | Not described Receives: Drug: BSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative: Day 1
Secondary outcomes (2)
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.
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start17 Apr 2023
- Primary completion21 Feb 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adam Fedyk, MD, FACS
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor-investigator, Adam Fedyk, MD, FACS, St. Louis Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853978
- Sponsor's protocol ID
- ARF-23-001
- Status last verified
- Jul 2025
- First submitted
- 2 May 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Balanced Salt Solution During Cataract Surgery
- ClinicalTrials.gov ID
- NCT05853978
- Acronym / sponsor ID
- ARF-23-001
- Conditions
- Fuchs Dystrophy, Cataract
- Keywords
- Fuchs Corneal Endothelial Dystrophy, Nuclear Sclerosis, Cataract Surgery, Paired Eye, ARF-23-001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Adam Fedyk, MD, FACSUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BSS Plus | Experimental | Drug: BSS Plus |
| BSS | Active comparator | Drug: BSS |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults, 22 years of age or older, with bilateral visually significant cataracts.
- Subjects with Fuch's Dystrophy that present with:
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BSS PlusBSS PLUS® Sterile Intraocular Irrigating Solution (balanced salt solution enriched with bicarbonate, dextrose, and glutathione) | Drug | BSS Plus |
| BSSBSS® Sterile Irrigating Solution (balanced salt solution) | Drug | BSS |
Primary outcome
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
2 secondary outcomes
Intraoperative Grading of Corneal Edema
Time frame: Day 0
Number of Intraocular Irrigating Solution Drops Used
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Fuchs Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BSS Plus and BSS in people with Fuchs Dystrophy and Cataract, run by Adam Fedyk, MD, FACS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Corneal Thickness (CCT) (time frame: Postoperative: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.