Fuchs Dystrophy, Cataract
Conditions
Keywords
Fuchs Corneal Endothelial Dystrophy, Nuclear Sclerosis, Cataract Surgery, Paired Eye, ARF-23-001
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.
Interventions
Sponsors
Alcon Research
Adam Fedyk, MD, FACS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults, 22 years of age or older, with bilateral visually significant cataracts. 2. Subjects with Fuch's Dystrophy that present with: 1. nonconfluent and confluent guttata; and/or 2. CCT \> 580 microns. 3. Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension 4. Ability to comprehend and sign a statement of informed consent. 5. Ability to complete all required postoperative visits. 6. 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
1. Planned implantation of multifocal intraocular lenses. 2. Planned secondary procedure(s) to occur in conjunction with cataract surgery (i.e., goniotomy) 3. History of severe dry eye. 4. Retinal and retinal vascular pathologies, age-related macular degeneration 5. Uncontrolled systematic diseases, including: hypertension, diabetes, systemic cardiovascular diseases and hematological diseases. 6. Autoimmune disease such as rheumatoid arthritis. 7. Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Corneal Thickness (CCT) | 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
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Grading of Corneal Edema | Day 0 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) | 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. |
| Corneal Surface Keratopathy and Conjunctival Staining | 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. |
| Endothelial Cell Density (ECD) | Postoperative: Month 1 | Endothelial Cell Density (ECD) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution. |
| Conjunctival Injection | 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. |
| Ocular Comfort Index (OCI) | 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. |
Countries
United States
Outcome results
None listed