The Evaluation of Balanced Salt Solution During Cataract Surgery

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Adam Fedyk, MD, FACS
• Collaborator: Alcon Research

Criteria

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.