Macula; Degeneration, Congenital or HereditaryNCT03517241
Objective Assessment of Macular Function at Retinal and Cortical Levels
An observational study of Macula; Degeneration, Congenital or Hereditary and Retina Disorder, run by Medical University of Vienna.
Trial summary
Research questions/hypotheses: About 15% of the population over 40 years of age are affected by diseases of the retina. Accurate measurement of the extent of visual field impairment is of highest importance for disease subtype diagnosis and severity classification. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Macula; Degeneration, Congenital or Hereditary, Retina Disorder
- What is being tested?
- functional magnetic resonance imaging (fMRI), Microperimetry (MP) and Optical coherence tomography (OCT)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2018to 15 Jun 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Consecutive enrollment from the Macular Disease Unit of the Dept. of Ophthalmology, Medical University of Vienna.
Who may be able to join
- 20 patients clinically diagnosed with GA secondary to AMD.
- 20 patients clinically and genetically diagnosed with STGD.
- 20 patients clinically diagnosed with BRAO.
- 20 patients clinically diagnosed with acute FTMH before and after macular surgery.
- 20 healthy control subjects. Visual acuity of 20/16- 20/32
Who cannot join
- Presence of any other ophthalmological or neurological disease affecting visual function
- Cataract > grade 2 (according to lens opacities system)
- All routine exclusion criteria that apply to MRI scans including pacemakers, metallic implants, prostheses or coils, claustrophobia
- Pregnancy
- Dyslexia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multimodal Approach Towards an Objective Assessment of Macular Function at Retinal and Cortical Levels
Research questions/hypotheses: About 15% of the population over 40 years of age are affected by diseases of the retina. Accurate measurement of the extent of visual field impairment is of highest importance for disease subtype diagnosis and severity classification. The current gold-standard approach for the assessment of macular sensitivity is microperimetry (MP) where the patient is asked to report whether or not visual stimuli presented at different positions within the visual field are detected. While this technique is a very straightforward approach and simple in its application, it is important to note that MP is psychophysical in nature and requires constantly high attentional performance of the patient throughout the examination period. As many patients suffering from retinal diseases are well over 65 years of age, they are unable to maintain such high levels of attention over longer periods and, thus, MP results may be biased. Retinotopic assessment using population receptive field (pRF) mapping based on functional magnetic resonance imaging (fMRI) offers an alternative by allowing for objective visual field testing, independent of patient performance. We have shown previously in healthy subjects that pRF allows for accurate detection of simulated central scotomata down to 2.35 degrees radius. Also, pilot data in patients with retinal scotomata showed strong correspondence between pRF and MP results, i.e. macular regions with reduced macular sensitivity and atrophy of outer retinal layers correlated well with pRF coverage maps showing reduced density of activated voxels. The aim of this project is to determine whether pRF mapping could serve as an alternative visual field testing method by: (1) assessing test-retest reproducibility of pRF and MP in clinical populations with stable retinal diseases (Stargardt disease, geographic atrophy) over a four-week period; (2) assessing visual field changes over a one-year period in patients suffering from acute retinal scotomata (branch retinal artery occlusions, full-thickness macular holes). All pRF mapping will be accompanied by MP measurements to allow for a direct comparison of the two techniques.
Scientific/scholarly innovation/originality of the project: The present project applies a novel approach for linking retinal function assessed with MP and pRF mapping in a representative patient population with acute and chronic retinal diseases. The project seeks to contribute to best practice methods for using fMRI to assess macular dysfunction both for documentation of the natural course of the disease and during therapy in a study setting.
Methods: fMRI uses pRF mapping to provide retinotopic data (pRF coverage maps) that are then correlated with the results of conventional ophthalmic testing including MP, visual acuity and contrast sensitivity testing, reading performance, optical coherence tomography and autofluorescence imaging.
- Being tested
- functional magnetic resonance imaging (fMRI), Microperimetry (MP), Optical coherence tomography (OCT), Blue light fundus autofluorescence imaging (FAF), Visual testing
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional magnetic resonance imaging (fMRI)Diagnostic test
Retinotopic mapping using functional magnetic resonance imaging (fMRI) is based on MR images acquired with blood-oxygenation-level-dependent (BOLD) contrast to reveal areas of neuronal activity in the visual cortex
Microperimetry (MP)Diagnostic test
MP allows localized testing of retinal sensitivity of foveal, parafoveal and even more peripheral macular regions
Optical coherence tomography (OCT)Diagnostic test
Optical Coherence Tomography (OCT) is a non-invasive diagnostic technique that renders an in vivo cross sectional view of the retina.
Blue light fundus autofluorescence imaging (FAF)Diagnostic test
Fundus autofluorescence imaging (FAF), is a non-invasive diagnostic technique focusing on the fluorescent properties of pigments in the retina to generate images.
Visual testingDiagnostic test
Best-corrected visual acuity will be measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Reading acuity and reading speed will be examined using Radner Reading Charts. Reading acuity is measured in logRAD unit (= reading equivalent of logMAR) and in critical font size (critical reading size), reading speed is measured in words per minute (wpm). Contrast sensitivity will be determined using Pelli-Robson contrast sensitivity charts.
| Study group | Role | What they receive |
|---|---|---|
| Geographic atrophy secondary to AMD | 20 patients clinically diagnosed with geographic atrophy (GA) secondary to AMD. Receives: Diagnostic Test: functional magnetic resonance imaging (fMRI); Diagnostic Test: Microperimetry (MP); Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Blue light fundus autofluorescence imaging (FAF); Diagnostic Test: Visual testing | |
| Stargards disease | 20 patients clinically and genetically diagnosed with Stargards disease (STGD) Receives: Diagnostic Test: functional magnetic resonance imaging (fMRI); Diagnostic Test: Microperimetry (MP); Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Blue light fundus autofluorescence imaging (FAF); Diagnostic Test: Visual testing | |
| Branch retinal artery occlusion | 20 patients clinically diagnosed with branch retinal artery occlusion (BRAO) Receives: Diagnostic Test: functional magnetic resonance imaging (fMRI); Diagnostic Test: Microperimetry (MP); Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Blue light fundus autofluorescence imaging (FAF); Diagnostic Test: Visual testing | |
| Full thickness macular hole | 20 patients clinically diagnosed with acute full thickness macular hole (FTMH) before and after macular surgery Receives: Diagnostic Test: functional magnetic resonance imaging (fMRI); Diagnostic Test: Microperimetry (MP); Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Blue light fundus autofluorescence imaging (FAF); Diagnostic Test: Visual testing | |
| Healthy controls | 20 healthy control subjects. Visual acuity of 20/16- 20/32 Receives: Diagnostic Test: functional magnetic resonance imaging (fMRI); Diagnostic Test: Microperimetry (MP); Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Blue light fundus autofluorescence imaging (FAF); Diagnostic Test: Visual testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correspondence between coverage maps originating from microperimetry and population-receptive field mapping of the primary visual cortex measured by functional magnetic resonance imaging.
Qualitative and quantitative assessment of the correspondence between conventional functional assessment of retinal scotomata (microperimetry) and population-receptive field (pRF) mapping of the primary visual cortex measured by functional magnetic resonance imaging in patients clinically diagnosed with geographic atrophy secondary to age-related macular degeneration, Stargardts disease, branch retinal artery occlusions and full thickness macular holes before and after macular surgery. The microperimetry test grid (retinal sensitivity measured in Decibel, dB) willl be correlated with the pRF coverage maps calculated from fMRI data. Each dot represents the centre of a receptive field of a single voxel and every pRF centre is associated with a 2D Gaussian which together constitute the coverage map. Correspondence between coverage maps will be quantified by calculating the matching coefficient.
Measured: 2 years
Secondary outcomes (2)
Correspondence between coverage maps originating from structural imaging (optical coherence tomography and autofluorescence imaging) and population-receptive field mapping of the primary visual cortex measured by functional magnetic resonance imaging.
Qualitative and quantitative assessment of the correspondence between conventional structural assessment of retinal scotomata (optical coherence tomography and autofluorescence imaging) and population-receptive field (pRF) mapping of the primary visual cortex measured by functional magnetic resonance imaging in patients clinically diagnosed with geographic atrophy secondary to age-related macular degeneration, Stargardts disease, branch retinal artery occlusions and full thickness macular holes before and after macular surgery. The retinal layer thickness maps (measured in micometer, µm) willl be correlated with the pRF coverage maps calculated from fMRI data. Each dot represents the centre of a receptive field of a single voxel and every pRF centre is associated with a 2D Gaussian which together constitute the coverage map.Correspondence between coverage maps will be quantified by calculating the matching coefficient.
Measured: 2 years
Reproducibility assessment
Reproducibility of population-receptive field mapping of the primary visual cortex and of conventional ophthalmic assessment (microperimetry, visual acuity and contrast sensitivity testing, reading performance, optical coherence tomography and autofluorescence imaging) in patients with retinal scotomata secondary to Stargardt disease and geographic atrophy compared with normal control participants with artificial scotomata.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start15 May 2018 (estimated)
- Primary completion16 Mar 2020 (estimated)
- Study completion15 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macula; Degeneration, Congenital or HereditaryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Ritter, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517241
- Sponsor's protocol ID
- EK1816/2014
- Status last verified
- May 2018
- First submitted
- 17 Apr 2018
- Last updated
- 7 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Approach Towards an Objective Assessment of Macular Function at Retinal and Cortical Levels
- ClinicalTrials.gov ID
- NCT03517241
- Acronym / sponsor ID
- EK1816/2014
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 May 2018 (estimated)
- Primary completion
- 16 Mar 2020 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 7 May 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.
Research questions/hypotheses: About 15% of the population over 40 years of age are affected by diseases of the retina. Accurate measurement of the extent of visual field impairment is of highest importance for disease subtype diagnosis and severity classification. The current gold-standard approach for the assessment of macular sensitivity is microperimetry (MP) where the patient is asked to report whether or not visual stimuli presented at different positions within the visual field are detected. While this technique is a very straightforward approach and simple in its application, it is important to note that MP is psychophysical in nature and requires constantly high attentional performance of the patient throughout the examination period. As many patients suffering from retinal diseases are well over 65 years of age, they are unable to maintain such high levels of attention over longer periods and, thus, MP results may be biased. Retinotopic assessment using population receptive field (pRF) mapping based on functional magnetic resonance imaging (fMRI) offers an alternative by allowing for objective visual field testing, independent of patient performance. We have shown previously in healthy subjects that pRF allows for accurate detection of simulated central scotomata down to 2.35 degrees radius. Also, pilot data in patients with retinal scotomata showed strong correspondence between pRF and MP results, i.e. macular regions with reduced macular sensitivity and atrophy of outer retinal layers correlated well with pRF coverage maps showing reduced density of activated voxels. The aim of this project is to determine whether pRF mapping could serve as an alternative visual field testing method by: (1) assessing test-retest reproducibility of pRF and MP in clinical populations with stable retinal diseases (Stargardt disease, geographic atrophy) over a four-week period; (2) assessing visual field changes over a one-year period in patients suffering from acute retinal scotomata (branch retinal artery occlusions, full-thickness macular holes). All pRF mapping will be accompanied by MP measurements to allow for a direct comparison of the two techniques.
Scientific/scholarly innovation/originality of the project: The present project applies a novel approach for linking retinal function assessed with MP and pRF mapping in a representative patient population with acute and chronic retinal diseases. The project seeks to contribute to best practice methods for using fMRI to assess macular dysfunction both for documentation of the natural course of the disease and during therapy in a study setting.
Methods: fMRI uses pRF mapping to provide retinotopic data (pRF coverage maps) that are then correlated with the results of conventional ophthalmic testing including MP, visual acuity and contrast sensitivity testing, reading performance, optical coherence tomography and autofluorescence imaging.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Geographic atrophy secondary to AMD | – | Diagnostic Test: functional magnetic resonance imaging (fMRI), Diagnostic Test: Microperimetry (MP), Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Blue light fundus autofluorescence imaging (FAF), Diagnostic Test: Visual testing20 patients clinically diagnosed with geographic atrophy (GA) secondary to AMD. |
| Stargards disease | – | Diagnostic Test: functional magnetic resonance imaging (fMRI), Diagnostic Test: Microperimetry (MP), Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Blue light fundus autofluorescence imaging (FAF), Diagnostic Test: Visual testing20 patients clinically and genetically diagnosed with Stargards disease (STGD) |
| Branch retinal artery occlusion | – | Diagnostic Test: functional magnetic resonance imaging (fMRI), Diagnostic Test: Microperimetry (MP), Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Blue light fundus autofluorescence imaging (FAF), Diagnostic Test: Visual testing20 patients clinically diagnosed with branch retinal artery occlusion (BRAO) |
| Full thickness macular hole | – | Diagnostic Test: functional magnetic resonance imaging (fMRI), Diagnostic Test: Microperimetry (MP), Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Blue light fundus autofluorescence imaging (FAF), Diagnostic Test: Visual testing20 patients clinically diagnosed with acute full thickness macular hole (FTMH) before and after macular surgery |
| Healthy controls | – | Diagnostic Test: functional magnetic resonance imaging (fMRI), Diagnostic Test: Microperimetry (MP), Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Blue light fundus autofluorescence imaging (FAF), Diagnostic Test: Visual testing20 healthy control subjects. Visual acuity of 20/16- 20/32 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive enrollment from the Macular Disease Unit of the Dept. of Ophthalmology, Medical University of Vienna.
Key inclusion criteria (5 listed)
- 20 patients clinically diagnosed with GA secondary to AMD.
- 20 patients clinically and genetically diagnosed with STGD.
- 20 patients clinically diagnosed with BRAO.
- 20 patients clinically diagnosed with acute FTMH before and after macular surgery.
- 20 healthy control subjects. Visual acuity of 20/16- 20/32
Key exclusion criteria (5 listed)
- Presence of any other ophthalmological or neurological disease affecting visual function
- Cataract > grade 2 (according to lens opacities system)
- All routine exclusion criteria that apply to MRI scans including pacemakers, metallic implants, prostheses or coils, claustrophobia
- Pregnancy
- Dyslexia
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 |
|---|---|---|
| functional magnetic resonance imaging (fMRI)Retinotopic mapping using functional magnetic resonance imaging (fMRI) is based on MR images acquired with blood-oxygenation-level-dependent (BOLD) contrast to reveal areas of neuronal activity in the visual cortex | Diagnostic test | Branch retinal artery occlusion, Full thickness macular hole, Geographic atrophy secondary to AMD, Healthy controls, Stargards disease |
| Microperimetry (MP)MP allows localized testing of retinal sensitivity of foveal, parafoveal and even more peripheral macular regions | Diagnostic test | Branch retinal artery occlusion, Full thickness macular hole, Geographic atrophy secondary to AMD, Healthy controls, Stargards disease |
| Optical coherence tomography (OCT)Optical Coherence Tomography (OCT) is a non-invasive diagnostic technique that renders an in vivo cross sectional view of the retina. | Diagnostic test | Branch retinal artery occlusion, Full thickness macular hole, Geographic atrophy secondary to AMD, Healthy controls, Stargards disease |
| Blue light fundus autofluorescence imaging (FAF)Fundus autofluorescence imaging (FAF), is a non-invasive diagnostic technique focusing on the fluorescent properties of pigments in the retina to generate images. | Diagnostic test | Branch retinal artery occlusion, Full thickness macular hole, Geographic atrophy secondary to AMD, Healthy controls, Stargards disease |
| Visual testingBest-corrected visual acuity will be measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Reading acuity and reading speed will be examined using Radner Reading Charts. Reading acuity is measured in logRAD unit (= reading equivalent of logMAR) and in critical font size (critical reading size), reading speed is measured in words per minute (wpm). Contrast sensitivity will be determined using Pelli-Robson contrast sensitivity charts. | Diagnostic test | Branch retinal artery occlusion, Full thickness macular hole, Geographic atrophy secondary to AMD, Healthy controls, Stargards disease |
Primary outcome
Correspondence between coverage maps originating from microperimetry and population-receptive field mapping of the primary visual cortex measured by functional magnetic resonance imaging.
Time frame: 2 years
Qualitative and quantitative assessment of the correspondence between conventional functional assessment of retinal scotomata (microperimetry) and population-receptive field (pRF) mapping of the primary visual cortex measured by functional magnetic resonance imaging in patients clinically diagnosed with geographic atrophy secondary to age-related macular degeneration, Stargardts disease, branch retinal artery occlusions and full thickness macular holes before and after macular surgery. The microperimetry test grid (retinal sensitivity measured in Decibel, dB) willl be correlated with the pRF coverage maps calculated from fMRI data. Each dot represents the centre of a receptive field of a single voxel and every pRF centre is associated with a 2D Gaussian which together constitute the coverage map. Correspondence between coverage maps will be quantified by calculating the matching coefficient.
2 secondary outcomes
Correspondence between coverage maps originating from structural imaging (optical coherence tomography and autofluorescence imaging) and population-receptive field mapping of the primary visual cortex measured by functional magnetic resonance imaging.
Time frame: 2 years
Reproducibility assessment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Macula; Degeneration, Congenital or Hereditary and Retina Disorder, run by Medical University of Vienna.
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 5 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 7 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus Ritter, MD (+4314040079400, markus.ritter@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correspondence between coverage maps originating from microperimetry and population-receptive field mapping of the primary visual cortex measured by functional magnetic resonance imaging. (time frame: 2 years). 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 7 May 2018.