Other Retinal Disorders, Retinal Disease, Retinal Vascular Disorder
Conditions
Brief summary
The RBBK study is a non-interventional, prospective study that will characterize disease state biomarker levels from aqueous humor, vitreous humor, intraoperative tissue and saliva of subjects with various retinal and systemic pathologies.
Detailed description
The RBBK study is a non-interventional, prospective study that will characterize disease state biomarker levels from aqueous humor, vitreous humor, intraoperative tissue and saliva of subjects with various retinal and systemic pathologies. Participants are eligible to be included in the study only if all of the following criteria apply: 1. Men or women \> 18 years of age 2. Subjects with vitreoretinal disease in at least one eye receiving a retinal treatment intervention 3. Able and willing to provide signed informed consent The study will consist of a single visit and a retrospective chart review. The study visit will consist of: 1. Screening for eligibility; 2. Aqueous humor collection (if applicable); 3. Vitreous humor collection (if applicable); 4. Intraoperative tissue (if applicable); and 5. Saliva collection If applicable, approximately 50 microliters (or more, up to 1000 microliters) of aqueous fluid will be collected by anterior chamber paracentesis according to standard clinical procedures. If applicable, up to 2 milliliters of vitreous fluid will be collected according to standard clinical procedures. Specific tissue, such as scar tissue, are routinely removed from the eye during vitreoretinal procedures. When being removed during a standard of care surgical procedure, these tissues may be collected. Saliva will also be collected according to instructions found in the Saliva Oragene Dx Collection Kit.
Interventions
None listed
Sponsors
Greater Houston Retina Research
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Subjects with vitreoretinal disease in at least one eye receiving a retinal treatment intervention
Exclusion criteria
1. Prior intraocular or subtenon steroid injection in the study eye within the prior 1 month of signing informed consent 2. Intraocular or refractive surgery in the study eye within 30 days of signing informed consent 3. Systemic anti-VEGF treatment within 90 days of signing informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To quantify levels of disease state biomarkers implicated in the pathogenesis of various retinal and systemic pathologies | Baseline | An analysis of the ocular fluids and tissues of patients with various vitreoretinal diseases would allow for the development of a deeper understanding of the processes that contribute to their onset and may ultimately provide insight in methods to refine treatment and management options. |
Countries
United States
Outcome results
None listed