Can COVID-19 Persist in Intraocular Fluid?

NCT04945850 | Completed

• 1 other identifier: 100800
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Several common viruses thrive and persist in intraocular fluid due to ocular immune privilege. Immune privilege is maintained by lack of lymphatic tissue, a strong blood ocular barrier, and regulation of the systemic immune response via immunosuppressive factors such as TGF-B and processes like anterior chamber associated immune deviation. Notable viruses that benefit from ocular immune sequestration include DNA viruses such as Herpes simplex virus, Varicella Zoster, Cytomegalovirus and RNA viruses like Ebola and Rubella.In light of the global 2019 Severe acute respiratory syndrome coronavirus-2 virus (SARS CoV-2 or commonly COVID-19) pandemic, there has been growing interest on COVID-19's long term effects on the ocular system. Ocular symptoms at the time of diagnosis and during illness have been reported previously. The most commonly reported are epiphora, chemosis, and conjunctivitis. Less common were findings of retinal hemorrhages and retinal ischemic changes. Recent literature has demonstrated its presence in ocular fluid such as tears and the aqueous humor, but whether this is sustained for an extended period of time has yet to be determined. Long term effects of covid on the neurological system are being identified - large vessel ischemic strokes, cerebral hemorrhages, cranial nerve palsies, and memory loss in young adults are being reported. The persistence of COVID 19 in the intraocular fluid several months after covid infection has not been studied previously.

Conditions

Ocular Infection, Viral

Outcome Measures

Primary Outcomes (4)

• Presence of Covid-19

  We aim to examine the presence of COVID-19 in the intraocular fluid.

  12 months

• Duration of persistent virus isolation

  Duration of persistent virus isolation from intraocular fluid

  12 months

• Microbiological methods

  microbiological methods of diagnosing.

  12 months

• Analyzing COVID-19

  Analyzing COVID-19 using ocular fluids.

  12 months

Study Arms (2)

Covid negative

20 patients undergoing ocular surgery who are COVID negative will be included as control patients and undergo the same procedures. All patients will get a vitreous tap from operative eye 0.1-0.2 ml fluid. This fresh sample will be tubed to the lab using a unique marked label. This will be performed after the trocar is placed At the end of surgery, the BSS bag will be tubed to the lab using the same label.

Procedure: routine care intraocular sx

Covid positive

60 patients undergoing ocular surgery with previous COVID infection will be stratified into three groups by time since diagnoses: 3, 6, 12 months \~ 20 patients per group. All patients will get a vitreous tap from operative eye 0.1-0.2 ml fluid. This fresh sample will be tubed to the lab using a unique marked label. This will be performed after the trocar is placed At the end of surgery, the BSS bag will be tubed to the lab using the same label.

Procedure: routine care intraocular sx

Interventions

routine care intraocular sx PROCEDURE

Fluid was collected during routine intraocular surgery

Covid negative; Covid positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We plan to recruit 80 patients to be enrolled in the study. This will be 20 COVID negative patients and 60 COVID positive patients stratified into three groups (20 per group) based on time since diagnosis as detailed above. This will provide sufficient sample size to be able to identify if the presence of covid in the eye is associated with prior infection and how long the virus can subsist in intraocular fluid.

You may qualify if:

• years of age or older
• Proof of previous COVID-19 infection
• Patients scheduled for elective ocular surgery at Vanderbilt Medical Center

You may not qualify if:

• 17 years of age and younger

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Eye Infections, Viral

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Virus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 30, 2021
• Study Start: June 16, 2021
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)