Assessment of COVID-19 in Tearfilm

Patients who underwent COVID-19 testing at VUMC (Vanderbilt University Medical Center) and
had provided a written informed consent to be contacted in the future for COVID related
studies will be offered participation in this study. The COVID- 19 has low prevalence in
ocular fluids (5% of affected patients) but may survive for a long time or replicate in the
conjunctiva, even in asymptomatic patients. Patients with viral conjunctivitis are more
likely to have COVID-19 RNA (ribonucleic acid) in tears. The use of Schirmer's strips to
collect tears for RNA analysis of viruses has been previously validated. VUMC is performing
RNA analysis on nasopharyngeal (NP) swabs for COVID-19 at several locations. Several patients
(test positive and test negative) have given consent to be contacted for future research
purposes and are available in VICTR (Vanderbilt Institute for Clinical and Translational
Research) Datamark and Recovery databases. The positive tested patients will receive a
Schirmer's strip in the mail at their home to place in both eyes to test eye fluid and
receive a tube for saliva while engaging in a zoom session for monitoring of the process.

Methodology: Patients who underwent COVID-19 testing at VUMC and had provided a written
informed consent to be contacted in the future for COVID related studies will be offered
participation in this study. The first test for eye fluid and saliva will occur at home with
remote monitoring. Participants will be mailed a specimen collection kit, engage in a remote
session with a study coordinator through a HIPPA (Health Insurance Portability and
Accountability Act of 1996)-compliant video meeting and collect specimens under supervision
of the study coordinator. Patients will receive a Schirmer's strip to place in both eyes
without topical proparacaine, and a tube to collect saliva. The strips are then sent to the
lab in universal viral transport media. Patients who have positive COVID-19 RNA in tears will
get repeat Schirmer's test every 4 weeks for 3 months- independent of the nasopharyngeal test
results. After a 3-month period, they will be offered a clinic visit at VEI (Vanderbilt Eye
Institute) for full dilated eye exam, fluorescein angiography and aqueous biopsies. Lab
testing for COVID-19 RNA and other ocular inflammatory mediators will be performed by Dr.
Johnathan Schmitz's lab at VUMC under standard viral precautions. All lab analysis will be
performed under a research protocol and not for clinical assessment or reporting.