A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
Primary Purpose
Conjunctivitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RPS Adeno Detector IV
Sponsored by
About this trial
This is an interventional diagnostic trial for Conjunctivitis focused on measuring Pink Eye,, Viral conjunctivitis, Adenoviral conjunctivitis, Keratoconjunctivitis
Eligibility Criteria
Inclusion Criteria:
- A total of 150 patients will be enrolled and who present prospectively to either a private practice or academic center with a presumed diagnosis of acute viral conjunctivitis while an internal review board (IRB) approved ophthalmologist is available and determined by the ophthalmologist to have met the following criteria for the clinical diagnosis of acute viral conjunctivitis will be included in the study.
- Criteria for clinical diagnosis of viral conjunctivitis. Requires that patients are at least 1 month old and present within 7 days of developing a red eye with at least 1 criteria from each of the 3 categories below:
I History: 1) Spread from 1 eye to the other several days later, 2) a recent history of an upper respiratory infection (URI)
II Signs: 1) presence of follicles, 2) presence of a preauricular node
III Symptoms: 1) watery - purulent discharge, 2) eyelash matting, 3) itching, or 4) foreign body sensation
Exclusion Criteria:
- Patients with allergy to corn starch, talcum powder, or dacron will be excluded.
- Patients with a corneal ulcer or history of recent trauma will also be excluded.
- Any patients who are using any topical ointment (including OTC artificial tear ointments) in the last 72 hours should be excluded.
- Patients using other topical ophthalmic medications (i.e. antibiotics) must allow 60 minutes prior to device application following any topical ophthalmic drops.
Sites / Locations
- Manatee Eye Clinic
- Center For Excellence in Eye Care
- St John's Clinic
- Ophthalmic Consultants of Long Island
- Weill-Cornell Medical College
- South Shore Eye Care
- Wills Eye Institute
- Northeastern Eye Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device Testing
Arm Description
Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
Outcomes
Primary Outcome Measures
Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.
Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.
Secondary Outcome Measures
Full Information
NCT ID
NCT00921895
First Posted
June 14, 2009
Last Updated
November 1, 2021
Sponsor
Rapid Pathogen Screening
1. Study Identification
Unique Protocol Identification Number
NCT00921895
Brief Title
A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
Official Title
A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rapid Pathogen Screening
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To engage in a multi-center, prospective, masked clinical trial to investigate a non-invasive, rapid diagnostic test, the RPS Adeno Detector IV's ability to detect the presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to cell culture with confirmatory immunofluorescence (CC-IFA). The polymerase chain reaction (PCR) will be used as a referee for discrepant cases.
Detailed Description
The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis
Keywords
Pink Eye,, Viral conjunctivitis, Adenoviral conjunctivitis, Keratoconjunctivitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device Testing
Arm Type
Experimental
Arm Description
Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
Intervention Type
Device
Intervention Name(s)
RPS Adeno Detector IV
Intervention Description
One time test with the RPS Adeno Detector IV
Primary Outcome Measure Information:
Title
Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.
Description
Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A total of 150 patients will be enrolled and who present prospectively to either a private practice or academic center with a presumed diagnosis of acute viral conjunctivitis while an internal review board (IRB) approved ophthalmologist is available and determined by the ophthalmologist to have met the following criteria for the clinical diagnosis of acute viral conjunctivitis will be included in the study.
Criteria for clinical diagnosis of viral conjunctivitis. Requires that patients are at least 1 month old and present within 7 days of developing a red eye with at least 1 criteria from each of the 3 categories below:
I History: 1) Spread from 1 eye to the other several days later, 2) a recent history of an upper respiratory infection (URI)
II Signs: 1) presence of follicles, 2) presence of a preauricular node
III Symptoms: 1) watery - purulent discharge, 2) eyelash matting, 3) itching, or 4) foreign body sensation
Exclusion Criteria:
Patients with allergy to corn starch, talcum powder, or dacron will be excluded.
Patients with a corneal ulcer or history of recent trauma will also be excluded.
Any patients who are using any topical ointment (including OTC artificial tear ointments) in the last 72 hours should be excluded.
Patients using other topical ophthalmic medications (i.e. antibiotics) must allow 60 minutes prior to device application following any topical ophthalmic drops.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shachar Tauber, MD
Organizational Affiliation
St John's Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jodi Luchs, MD
Organizational Affiliation
South Shore Eye Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Trattler, MD
Organizational Affiliation
Center For Excellence In Eye Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Boland, MD
Organizational Affiliation
Northeastern Eye Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael DellaVecchia, MD/PhD
Organizational Affiliation
Wills Eye Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Murray Friedberg, MD
Organizational Affiliation
Manatee Eye Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Starr, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marguerite McDonald, MD
Organizational Affiliation
Ophthalmic Consultants of Long Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manatee Eye Clinic
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Center For Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
St John's Clinic
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Weill-Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
South Shore Eye Care
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Northeastern Eye Institute
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18503
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23307204
Citation
Sambursky R, Trattler W, Tauber S, Starr C, Friedberg M, Boland T, McDonald M, DellaVecchia M, Luchs J. Sensitivity and specificity of the AdenoPlus test for diagnosing adenoviral conjunctivitis. JAMA Ophthalmol. 2013 Jan;131(1):17-22. doi: 10.1001/2013.jamaophthalmol.513. Erratum In: JAMA Ophthalmol. 2013 Mar;131(3):320.
Results Reference
derived
Learn more about this trial
A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
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