The Evaluation of Balanced Salt Solution During Cataract Surgery

Adam Fedyk, MD, FACS

Status and phase: Active, not recruiting; Phase 4

Conditions: Cataract; Fuchs Dystrophy

Treatments: Drug: BSS; Drug: BSS Plus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05853978

ARF-23-001

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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27 participants in 2 patient groups

BSS Plus

Experimental group

Treatment:

Drug: BSS Plus

BSS

Active Comparator group

Treatment:

Drug: BSS