HealthyORPHEE2NCT02091700
ObseRvation of PeripHEral rEtinal Morphology in Normals
An observational study of Healthy, run by Optos, PLC at 1 site in United States.
Trial summary
To develop a database of the peripheral choroidal circulation using ultra widefield (UWF) imaging. This database will serve as a quantitative reference tool for the comparison of subjects to a database of known normal subjects. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Indocyanine Green ICG
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2017to Jul 2017
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal subjects with no known retinal disease or choroidal disease.
Who may be able to join
- Subjects older than 20 years old with good general health.
- Subject is capable of giving consent.
- The subject is able and willing to comply with the study procedures.
- Subjects with ocular media clear enough to allow good quality ocular imaging.
- Normal subjects with no known retinal or choroidal disease.
Who cannot join
- Subjects under 20 years old.
- Subjects with contraindications to dilation.
- Subjects with a history of epilepsy.
- Subjects with a known allergy to iodine, shellfish or intra-venous x-ray contrast dyes.
- Subjects who are or who may be pregnant.
- Subjects with past history of any vitreoretinal disease or surgery such as retinal detachment, epiretinal membrane, or vitreous hemorrhage.
Show all 13Show fewer
- Subjects with any ocular condition that interferes with good quality image acquisition, such as corneal opacities, cataract, and dense vitreous hemorrhage.
- Subjects with any evidence of any retinal or optic nerve disease including glaucoma.
- Subjects with any anterior segment disease with the exception of common ocular surface disorders (blepharitis, dry eye).
- Subjects with medical conditions that interfere with the subject's compliance to study procedures such as inability of the subject to maintain steady head or eye positioning as in patients of ataxia or nystagmus.
- Subjects with a history of Diabetes, uncontrolled blood pressure (defined as systolic >/= 160mmHg and/or diastolic >/= 90 mmHg), and Vascular Disease (cardiovascular, peripheral vascular, or cerebrovascular).
- Subjects on vasodilators.
- Subject's refusal.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Cathy Ellis, BS, MT, 210-697-2036 ext. 2270, cathy@mcoaeyecare.com
Tamara Urias, 201-697-2036 ext. 2239, turias@mcoaeyecare.com
About this study
Official title: ObseRvation of PeripHEral rEtinal Morphology in Normal
To develop a database of the peripheral choroidal circulation using ultra widefield (UWF) imaging. This database will serve as a quantitative reference tool for the comparison of subjects to a database of known normal subjects.
- Conditions
- Healthy
- Being tested
- Indocyanine Green ICG
- Keywords
- Normal, Healthy, Normal healthy patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green ICGOther
| Study group | Role | What they receive |
|---|---|---|
| Normals | Subjects with normal visual and retinal function will be enrolled Receives: Other: Indocyanine Green ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a database of peripheral retinal circulation in normals using UWF-ICG imaging
Measured: 1 day
Secondary outcomes (1)
Develop a database of peripheral retinal morphology on age stratified normals using color, AF and ICG imaging
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2017 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optos, PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Center Ophthalmology Associates San Antonio, Texas
- Responsible party
- Sponsor
- Investigators
- Michael Singer, MD, Principal investigator, Medical Center Ophthalmology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091700
- Sponsor's protocol ID
- OPT1010
- Acronym
- ORPHEE2
- Status last verified
- Mar 2017
- First submitted
- 5 Mar 2014
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ObseRvation of PeripHEral rEtinal Morphology in Normal
- ClinicalTrials.gov ID
- NCT02091700
- Acronym / sponsor ID
- ORPHEE2 / OPT1010
- Conditions
- Healthy
- Keywords
- Normal, Healthy, Normal healthy patient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Optos, PLCIndustry (pharma, biotech, devices)
- Collaborators
- Medical Center Ophthalmology Associates San Antonio, Texas
- Study start
- Mar 2017 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 19 Mar 2014 (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.
To develop a database of the peripheral choroidal circulation using ultra widefield (UWF) imaging. This database will serve as a quantitative reference tool for the comparison of subjects to a database of known normal subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normals | – | Other: Indocyanine Green ICGSubjects with normal visual and retinal function will be enrolled |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal subjects with no known retinal disease or choroidal disease.
Key inclusion criteria (5 listed)
- Subjects older than 20 years old with good general health.
- Subject is capable of giving consent.
- The subject is able and willing to comply with the study procedures.
- Subjects with ocular media clear enough to allow good quality ocular imaging.
- Normal subjects with no known retinal or choroidal disease.
Key exclusion criteria (13 listed)
- Subjects under 20 years old.
- Subjects with contraindications to dilation.
- Subjects with a history of epilepsy.
- Subjects with a known allergy to iodine, shellfish or intra-venous x-ray contrast dyes.
- Subjects who are or who may be pregnant.
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 |
|---|---|---|
| Indocyanine Green ICG | Other | Normals |
Primary outcome
Develop a database of peripheral retinal circulation in normals using UWF-ICG imaging
Time frame: 1 day
1 secondary outcome
Develop a database of peripheral retinal morphology on age stratified normals using color, AF and ICG imaging
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
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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.
Michael Singer, MD principal investigator
Medical Center Ophthalmology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Optos, PLC 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Mar 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathy Ellis, BS, MT (210-697-2036 ext. 2270, cathy@mcoaeyecare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a database of peripheral retinal circulation in normals using UWF-ICG imaging (time frame: 1 day). 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 Mar 2017.