CataractNCT02558712
Technology-based Eye Care Services (TECS) Compare
A study testing Technology-based Eye Care Services (TECS) Protocol in people with Cataract and Macular Degeneration, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to compare the Technology-based Eye Care Services (TECS) protocol to the standard face to face ophthalmologic exam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Macular Degeneration, Glaucoma
- What is being tested?
- Technology-based Eye Care Services (TECS) Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 23 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at the Atlanta VA Medical Center (VAMC) New Comprehensive eye clinic
Who cannot join
- Known acute or chronic ocular issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparison of Technology-based Eye Care Services (TECS) With and Without OCT Assessment Versus Standard Face to Face Ophthalmologic Exam
The purpose of this study is to compare the Technology-based Eye Care Services (TECS) protocol to the standard face to face ophthalmologic exam.
Read the detailed description
Patients will sign informed consent to enter the one visit study. They will undergo the study protocol and then see the face to face physician on the same day.
- Conditions
- Cataract, Macular Degeneration, Glaucoma
- Being tested
- Technology-based Eye Care Services (TECS) Protocol
- Keywords
- screening, tele-ophthalmology
- Medical subject headings
- Cataract, Macular Degeneration, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-based Eye Care Services (TECS) ProtocolOther
Extensive History will be taken. Distance auto-refraction measurements will be made on both eyes. Eye pressure using the iCare tonometer and central corneal thickness (CCT) using the corneal pachymeter will be taken for each eye. Participants will have fundus photos taken following the standard VA diabetic teleretinal protocol. Then participants will have OCT Macula and Nerve performed. After protocol complete, then patients will see an ophthalmologist for standard eye exam.
| Study group | Role | What they receive |
|---|---|---|
| Face to face exam | Other | Standard of clinical care, 8 point eye exam Receives: Other: Technology-based Eye Care Services (TECS) Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with accurate diagnosis of eye diseases from TECS protocol versus face to face eye exam with and without OCT
Clinical diagnosis in dichotomous (yes/no) decision tree. The clinical diagnosis of the TECS protocol readers will be compared to the face to face physician, with the face to face serving as the standard of care. The results will be done with and without OCT. Sensitivity, specificity, positive and negative predictive value will be calculated before and after OCT.
Measured: Evaluation Visit (Day 0)
Secondary outcomes (4)
Number of patients appropriately referred from the TECS protocol
Total number of participants with a referral for face to face eye care with and without OCT
Measured: Evaluation visit (Day 0)
Number of participants with an accurate diagnosis for anterior segment disease
The responses from an anterior segment questionnaire will be compared to the findings of the face to face physician exam for accuracy, using a (yes/no) decision tree. Sensitivity, specificity will be calculated using the face to face exam as the standard of care.
Measured: Evaluation visit (Day 0)
Inter-reader variability of the TECS protocol
Kappa statistics reflecting the agreement between two readers on the same photo set of a single patient with and without OCT
Measured: Evaluation visit (Day 0)
Intra-reader variability of the TECS protocol
Kappa statistics measuring agreement of the same reader reading the photographs of the same patient twice (after a washout period between photo reading sets) with and without OCT.
Measured: Evaluation visit (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startMar 2016
- Primary completionSep 2017
- Study completion23 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, April Maa, Emory University
- Investigators
- April Maa, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558712
- Sponsor's protocol ID
- IRB00080630
- Status last verified
- Apr 2018
- First submitted
- 21 Sep 2015
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Technology-based Eye Care Services (TECS) With and Without OCT Assessment Versus Standard Face to Face Ophthalmologic Exam
- ClinicalTrials.gov ID
- NCT02558712
- Acronym / sponsor ID
- IRB00080630
- Conditions
- Cataract, Macular Degeneration, Glaucoma
- Keywords
- screening, tele-ophthalmology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- 23 Sep 2017 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the Technology-based Eye Care Services (TECS) protocol to the standard face to face ophthalmologic exam.
Detailed description
Patients will sign informed consent to enter the one visit study. They will undergo the study protocol and then see the face to face physician on the same day.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Face to face exam | Other | Other: Technology-based Eye Care Services (TECS) ProtocolStandard of clinical care, 8 point eye exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient at the Atlanta VA Medical Center (VAMC) New Comprehensive eye clinic
Key exclusion criteria (1 listed)
- Known acute or chronic ocular issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-based Eye Care Services (TECS) ProtocolExtensive History will be taken. Distance auto-refraction measurements will be made on both eyes. Eye pressure using the iCare tonometer and central corneal thickness (CCT) using the corneal pachymeter will be taken for each eye. Participants will have fundus photos taken following the standard VA diabetic teleretinal protocol. Then participants will have OCT Macula and Nerve performed. After protocol complete, then patients will see an ophthalmologist for standard eye exam. | Other | Face to face exam |
Primary outcome
Number of patients with accurate diagnosis of eye diseases from TECS protocol versus face to face eye exam with and without OCT
Time frame: Evaluation Visit (Day 0)
Clinical diagnosis in dichotomous (yes/no) decision tree. The clinical diagnosis of the TECS protocol readers will be compared to the face to face physician, with the face to face serving as the standard of care. The results will be done with and without OCT. Sensitivity, specificity, positive and negative predictive value will be calculated before and after OCT.
4 secondary outcomes
Number of patients appropriately referred from the TECS protocol
Time frame: Evaluation visit (Day 0)
Number of participants with an accurate diagnosis for anterior segment disease
Time frame: Evaluation visit (Day 0)
Inter-reader variability of the TECS protocol
Time frame: Evaluation visit (Day 0)
Intra-reader variability of the TECS protocol
Time frame: Evaluation visit (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
April Maa, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-based Eye Care Services (TECS) Protocol in people with Cataract and Macular Degeneration, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with accurate diagnosis of eye diseases from TECS protocol versus face to face eye exam with and without OCT (time frame: Evaluation Visit (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.