Macular DegenerationNCT02941406
MP3 (Microperimeter 3) Reproducibility in Healthy Subjects and Macular Patients
An observational study of Macular Degeneration, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
The aim of the present study is to investigate the reproducibility of the MP3 and to compare the results with conventional perimetry using the Octopus 101 in healthy subjects and patients with macular disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration
- How many people
- 22 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2015to Dec 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 healthy subjects 20 macular patients
Who may be able to join
- Men and Women aged 18 and older
- Written informed consent
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmological findings unless the investigator considers an abnormality to be clinically irrelevant
- Men and Women aged 18 and older
- Written informed consent
Show all 10Show fewer
- Presence of a macular disease (such as dry or exudative age-related macular degeneration, diabetic maculopathy, epiretinal membrane)
- Any of the following will exclude a subject from the study:
- Any opacities (corneal scar, dense cataract) which interferes with the study relevant measurements
- Visual acuity < 0.1 (Snellen)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reproducibility of Microperimetry Using Nidek MP3 (Microperimeter 3) in Healthy Subjects and Patients With Macular Disease - Pilot Study
The aim of the present study is to investigate the reproducibility of the MP3 and to compare the results with conventional perimetry using the Octopus 101 in healthy subjects and patients with macular disease.
- Conditions
- Macular Degeneration
- Keywords
- Retina, Perimetry
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | * Men and Women aged 18 and older * Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant * Normal ophthalmological findings unless the investigator considers an abnormality to be clinically irrelevant | |
| Age-related macular degeneration patients | * Men and Women aged 18 and older * Presence of a macular disease (such as dry or exudative age-related macular degeneration, diabetic maculopathy, epiretinal membrane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of retinal sensitivity measurements using microperimetry
Two study measurements are scheduled within one week. Test-retest reproducibility will be assessed for retinal sensitivity using the coefficient of repeatability and Bland-Altman diagrams.
Measured: Two measurement within one week
Secondary outcomes (1)
Comparison of reproducibility of retinal sensitivity measurements assessed with microperimetry and conventional perimetry
In addition to microperimetry conventional perimetry will be performed and reproducibility of both devices will be compared.
Measured: Two measurement within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, Prof., Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941406
- Sponsor's protocol ID
- MP3_REP
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Microperimetry Using Nidek MP3 (Microperimeter 3) in Healthy Subjects and Patients With Macular Disease - Pilot Study
- ClinicalTrials.gov ID
- NCT02941406
- Acronym / sponsor ID
- MP3_REP
- Conditions
- Macular Degeneration
- Keywords
- Retina, Perimetry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Oct 2016 (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 aim of the present study is to investigate the reproducibility of the MP3 and to compare the results with conventional perimetry using the Octopus 101 in healthy subjects and patients with macular disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | –* Men and Women aged 18 and older * Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant * Normal ophthalmological findings unless the investigator considers an abnormality to be clinically irrelevant |
| Age-related macular degeneration patients | – | –* Men and Women aged 18 and older * Presence of a macular disease (such as dry or exudative age-related macular degeneration, diabetic maculopathy, epiretinal membrane) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 healthy subjects 20 macular patients
Key inclusion criteria (10 listed)
- Men and Women aged 18 and older
- Written informed consent
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmological findings unless the investigator considers an abnormality to be clinically irrelevant
- Men and Women aged 18 and older
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reproducibility of retinal sensitivity measurements using microperimetry
Time frame: Two measurement within one week
Two study measurements are scheduled within one week. Test-retest reproducibility will be assessed for retinal sensitivity using the coefficient of repeatability and Bland-Altman diagrams.
1 secondary outcome
Comparison of reproducibility of retinal sensitivity measurements assessed with microperimetry and conventional perimetry
Time frame: Two measurement within one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
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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.
Oliver Findl, MD, Prof. principal investigator
Vienna Institute for Research in Ocular Surgery
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 Macular Degeneration, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
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 10 inclusion and 0 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 21 Oct 2016. 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 Austria. 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?
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?
Reproducibility of retinal sensitivity measurements using microperimetry (time frame: Two measurement within one week). 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 21 Oct 2016.