HealthyHydra01NCT03419390
A Pilot Study for the Evaluation of the Safety and Performance of a Combined OCT System
A study testing combined Coaxial Optical Coherence Tomography (OCT) System in people with Healthy, run by University Hospital, Basel, Switzerland.
Trial summary
The novel Coaxial Optical Coherence Tomography (OCT) System is designed to visualize both structures of the retina and choroid. The purpose of this research is the safety and evaluation of a combined coaxial optical coherence tomography (OCT) system, to image diseases of the posterior and anterior segment of the eye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- combined Coaxial Optical Coherence Tomography (OCT) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with healthy eye, or has been diagnosed already with eye disease
- Patients > 18 years of age
- Informed Consent as documented by date and signature
Who cannot join
- Clinically significant concomitant disease that impair measurement
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, late stage Alzheimer disease, etc. of the participant,
- Subjects using implanted electronic medical devices (e.g. cochlear implant, pacemaker, defibrillator, infusion pump).
- Participation in another study with investigational drug within the 30 days preceding and during the present study
About this study
Official title: A Prospective,Open Label,Non-randomized,Single-centre,Exploratory,Stratified Pilot Study for the Evaluation of the Safety and Performance of a Combined Coaxial Optical Coherence Tomography (OCT) System,to Image Diseases of the Posterior and Anterior Segment of the Eye
The novel Coaxial Optical Coherence Tomography (OCT) System is designed to visualize both structures of the retina and choroid.
The purpose of this research is the safety and evaluation of a combined coaxial optical coherence tomography (OCT) system, to image diseases of the posterior and anterior segment of the eye.
Read the detailed description
Background and Rationale:
Many posterior segment ocular diseases involve the retinal and choroidal vasculature. A new technology to noninvasively and simultaneously visualize vascular pathology is of utmost importance to reduce patient exposure to different diagnosis methods like e.g. fluorescence angiography. The novel Coaxial Optical Coherence Tomography (OCT) System is designed to visualize both structures of the retina and choroid.
Furthermore, it may be used to image other structures of the eye.
Objective(s):
The purpose of this research is the safety and evaluation of a combined coaxial optical coherence tomography (OCT) system, to image diseases of the posterior and anterior segment of the eye. This device may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Glaucoma, Diabetic Retinopathy or Age-Related Macular Degeneration. Measurements are compared to normal controls.
Measurements and procedures:
After screening, all participants will undergo a scanning procedure on the same day.
Only one eye of each participant will be scanned with the investigational device. For patients, the eye showing the disease will be chosen, for healthy volunteers, the left or right eye will be scanned according to a randomisation list.
The image quality is rated by the investigator and an independent assessor on a VAS (visual analogue scale). A subgroup of each stratum will have a comparative measurement of the choroid thickness against a SS-OCT (swept-source-OCT) device (Topcon) and a retina thickness against the Spectralis data. The subgroup will consist of half planned sample size. The measurement is taken from one eye, ie. every second participant per stratum will be attributed to the thickness measurement subgroup. The endpoint is a true/false criterion on whether the measurement of the retina and choroid thickness was successful. The thickness is measured in μm. The measurement is considered a "success" if the value is no more than +/- 10% off the reference measurement.
- Conditions
- Healthy
- Being tested
- combined Coaxial Optical Coherence Tomography (OCT) System
- Keywords
- Hydra01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined Coaxial Optical Coherence Tomography (OCT) SystemDevice
The investigational device is an OCT scanner prototype with two different wavelengths developed based on a CE marked OCT device (Spectralis® Heidelberg) at the Berner Fachhochschule, Biel
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Other | One eye of each participant will be scanned with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System) Receives: Device: combined Coaxial Optical Coherence Tomography (OCT) System |
| Diseased groups | Other | lf one eye is affected, this will be chosen. lf both eyes are be affected, the eye with the severest symptoms will be chosen. Scanning with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System) Receives: Device: combined Coaxial Optical Coherence Tomography (OCT) System |
| Diseased subgroups | Other | Every second subject will be allocated to the subgroup.
1. Scanning with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System)
2. Thickness measurement with reference medical device. Receives: Device: combined Coaxial Optical Coherence Tomography (OCT) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (VA) after investigation
Safety of the imaging investigation expressed as visual acuity before (baseline) and after imaging, and tolerability assessment questionnaire.
Measured: Within 1 hour after investigation
Secondary outcomes (3)
Scan quality
Comparing scan quality of investigational device to scan quality of a reference device, expressed as thickness of the retina and the thickness of the choroid
Measured: After completion of all measurement, an average of 2 years.
Procedural success
Procedural success that is defined as: Image Quality of anterior and posterior eye structures
Measured: After completion of all measurement, an average of 2 years.
Procedural safety and comfort assessed by questionnaire
Procedural comfort in the opinion of the patients assessed with a questionnaire
Measured: Within 1 hour after investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Dec 2016
- Primary completionMar 2017
- Study completionDec 2019
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.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Proof of concept study, medical device investigation
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hendrik PN Scholl, MD, Study director, University Hospital Basel, Dept. of OphthalmologyPascal Hasler, MD, Principal investigator, University Hospital Basel, Dept. of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419390
- Sponsor's protocol ID
- 085-HAP-2017-001
- Acronym
- Hydra01
- Status last verified
- Mar 2020
- First submitted
- 17 Nov 2017
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Open Label,Non-randomized,Single-centre,Exploratory,Stratified Pilot Study for the Evaluation of the Safety and Performance of a Combined Coaxial Optical Coherence Tomography (OCT) System,to Image Diseases of the Posterior and Anterior Segment of the Eye
- ClinicalTrials.gov ID
- NCT03419390
- Acronym / sponsor ID
- Hydra01 / 085-HAP-2017-001
- Conditions
- Healthy
- Keywords
- Hydra01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- 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 novel Coaxial Optical Coherence Tomography (OCT) System is designed to visualize both structures of the retina and choroid.
The purpose of this research is the safety and evaluation of a combined coaxial optical coherence tomography (OCT) system, to image diseases of the posterior and anterior segment of the eye.
Detailed description
Background and Rationale:
Many posterior segment ocular diseases involve the retinal and choroidal vasculature. A new technology to noninvasively and simultaneously visualize vascular pathology is of utmost importance to reduce patient exposure to different diagnosis methods like e.g. fluorescence angiography. The novel Coaxial Optical Coherence Tomography (OCT) System is designed to visualize both structures of the retina and choroid.
Furthermore, it may be used to image other structures of the eye.
Objective(s):
The purpose of this research is the safety and evaluation of a combined coaxial optical coherence tomography (OCT) system, to image diseases of the posterior and anterior segment of the eye. This device may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Glaucoma, Diabetic Retinopathy or Age-Related Macular Degeneration. Measurements are compared to normal controls.
Measurements and procedures:
After screening, all participants will undergo a scanning procedure on the same day.
Only one eye of each participant will be scanned with the investigational device. For patients, the eye showing the disease will be chosen, for healthy volunteers, the left or right eye will be scanned according to a randomisation list.
The image quality is rated by the investigator and an independent assessor on a VAS (visual analogue scale). A subgroup of each stratum will have a comparative measurement of the choroid thickness against a SS-OCT (swept-source-OCT) device (Topcon) and a retina thickness against the Spectralis data. The subgroup will consist of half planned sample size. The measurement is taken from one eye, ie. every second participant per stratum will be attributed to the thickness measurement subgroup. The endpoint is a true/false criterion on whether the measurement of the retina and choroid thickness was successful. The thickness is measured in μm. The measurement is considered a "success" if the value is no more than +/- 10% off the reference measurement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Proof of concept study, medical device investigation
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Other | Device: combined Coaxial Optical Coherence Tomography (OCT) SystemOne eye of each participant will be scanned with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System) |
| Diseased groups | Other | Device: combined Coaxial Optical Coherence Tomography (OCT) Systemlf one eye is affected, this will be chosen. lf both eyes are be affected, the eye with the severest symptoms will be chosen. Scanning with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System) |
| Diseased subgroups | Other | Device: combined Coaxial Optical Coherence Tomography (OCT) SystemEvery second subject will be allocated to the subgroup. 1. Scanning with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System) 2. Thickness measurement with reference medical device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with healthy eye, or has been diagnosed already with eye disease
- Patients > 18 years of age
- Informed Consent as documented by date and signature
Key exclusion criteria (4 listed)
- Clinically significant concomitant disease that impair measurement
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, late stage Alzheimer disease, etc. of the participant,
- Subjects using implanted electronic medical devices (e.g. cochlear implant, pacemaker, defibrillator, infusion pump).
- Participation in another study with investigational drug within the 30 days preceding and during the present study
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 |
|---|---|---|
| combined Coaxial Optical Coherence Tomography (OCT) SystemThe investigational device is an OCT scanner prototype with two different wavelengths developed based on a CE marked OCT device (Spectralis® Heidelberg) at the Berner Fachhochschule, Biel | Device | Diseased groups, Diseased subgroups, Healthy subjects |
Primary outcome
Visual acuity (VA) after investigation
Time frame: Within 1 hour after investigation
Safety of the imaging investigation expressed as visual acuity before (baseline) and after imaging, and tolerability assessment questionnaire.
3 secondary outcomes
Scan quality
Time frame: After completion of all measurement, an average of 2 years.
Procedural success
Time frame: After completion of all measurement, an average of 2 years.
Procedural safety and comfort assessed by questionnaire
Time frame: Within 1 hour after investigation
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 1 Apr 2020.
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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.
Hendrik PN Scholl, MD study director
University Hospital Basel, Dept. of Ophthalmology
Pascal Hasler, MD principal investigator
University Hospital Basel, Dept. of Ophthalmology
Questions about this trial
What is this clinical trial studying?
A study testing combined Coaxial Optical Coherence Tomography (OCT) System in people with Healthy, run by University Hospital, Basel, Switzerland.
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 3 inclusion and 4 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 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual acuity (VA) after investigation (time frame: Within 1 hour after investigation). 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 1 Apr 2020.