MetamorphopsiaNCT04112524
Comparison of Quantitative Metamorphopsia- Measurements in Patients With mCNV
An observational study of Metamorphopsia, run by PD Dr. med. Katja Hatz at 1 site in Switzerland.
Trial summary
The myopic CNV (mCNV) is a blood vessel neoplasm starting from the choroid, based on pathological myopia (severe myopia). Choroidal neovascularization secondary to pathological myopia is the most common cause of severe visual impairment in myopic patients younger than 50 years old. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metamorphopsia
- What is being tested?
- App
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Oct 2019to 2 Feb 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients in retina- routine control
Who may be able to join
- diagnosis of mCNV involving the juxtafoveal or/and foveal region
- BCVA >0.1 (20/200, Snellen)
- ability to follow the study procedures
- given written consent to participation
- >18 years
Who cannot join
- history of vitreoretinal surgery (including membrane peeling and retinal detachment surgery) to the study eye
- presence of macula foramen or epiretinal membrane with significant distortion of retinal architecture
- history of any side effects to Tropicamide eye drops
Trial locations and contacts
1 site in 1 country.
About this study
The myopic CNV (mCNV) is a blood vessel neoplasm starting from the choroid, based on pathological myopia (severe myopia).
Choroidal neovascularization secondary to pathological myopia is the most common cause of severe visual impairment in myopic patients younger than 50 years old. Because untreated small fibrovascular membranes cause rapid damage to the photoreceptors, timely treatment is required in view of poor spontaneous prognosis1.
Read more
Metamorphopsia is the first functional impairment which occurs in mCNV - visual acuity loss and scotoma follow later.
There is a need for better and quicker quantifying of the metamorphopsia in mCNV patients.
The aim of this study is to detect metamorphopsia and verify correlations of different indexes with disease activity or not, measured in Optical Cohorence Tomography (OCT), best corrected visual acuity (BCVA), Vision related quality of life questionnaire (NEI-VFY-25) and quantify severity of metamophopsia.
Read the detailed description
The myopic CNV is a neovascularization starting from the choroid and growing into the space between choroid and retina, based on pathological myopia (severe myopia). Choroidal neovascularization secondary to pathological myopia (mCNV) is the most common cause of severe visual impairment in myopic patients younger than 50 years old.1 As untreated subretinal fibrovascular membranes cause rapid damage to the photoreceptors, timely treatment is required in view of poor spontaneous prognosis.1
Metamorphopsia is the first functional impairment which occurs in mCNV - visual acuity loss and scotoma follow later. The Amsler Grid, a qualitative paper test developed the swiss ophthalmologist Marc Amsler (1891 - 1968), is a square-shaped grid used to detect or monitor metamorphopsia or scotoma involving the central visual field in various disorders of the macula and optic nerve head11.
Myopic CNV patients use the Amsler Grid as a home monitoring device for qualitative detection of metamorphopsia by checking the grid regularly11. Due to subretinal scarring in mCNV interpretation is often difficult and early changes cannot be detected and quantified. Until now there are no quantitative measurements for mCNV monitoring in clinical use.
Recently, two devices to detect and monitor metamorphopsia using smart phones and PCs, respectively, have been developed for use in choroidal neovascularization in age-related macular degeneration.5,6
- Alleye® Test Alleye® Test is a mobile medical software application indicated for the detection and characterization of metamorphopsia. For the mean Alleye score (±standard deviation (SD) deviations of dots from an ideal line are calculated for each eye.5
- AMD-A Metamorphopsia Detector® Is based on the Amsler grid. The software uses the concept of a negative image: a distorted image can be straightened by moving the mouse. Degree and dimension of distorted lines or scotoma are transformed into indices.6
This study was designed to find out whether these metamorphopsia applications are suitable for patients with mCNV and to find out if mCNV patients can benefit for a quicker detecting of the metamorphopsia.
Therefore, the aim of this study is to detect metamorphopsia and verify correlations of different indexes with disease activity or not, measured in Optical Cohorence Tomography (OCT), best corrected visual Acuity (BCVA), Vision related quality of life questionnaire (NEI-VFY-25) and quantify severity of metamophopsia.
- Conditions
- Metamorphopsia
- Being tested
- App
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppDevice
- Alleye® Test Alleye® Test is a mobile medical software application indicated for the detection and characterization of metamorphopsia. For the mean Alleye score (±standard deviation (SD) deviations of dots from an ideal line are calculated for each eye.
- AMD-A Metamorphopsia Detector® Is based on the Amsler grid. The software uses the concept of a negative image: a distorted image can be straightened by moving the mouse. Degree and dimension of distorted lines or scotoma are transformed into indices.
| Study group | Role | What they receive |
|---|---|---|
| Patients from routine treatment | all 30 patients from Routine Treatment, only observational Receives: Device: App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metamorphopsia index change from baseline (no mCNV activity) to month 6 and 12 and all visits in between (disease activity dependent) for the following two devices - AMD-A Metamorphopsia Detector® (app4eyes - TEST) - Alleye® Test
Metamorphopsia index change (disease activity)
Measured: 1 year
Secondary outcomes (3)
CRT (central retinal thickness) measured in OCT
CRT change (disease activity)
Measured: 1 year
-outer retina disruption score within central 1mm (measured in OCT) -maximum CNV thickness within central 1mm (measured in OCT) -area of pigment epithelium atrophy within central 1mm measured in autofluorescence imaging
Change of outer Retina disruption score and maximum CNV thickness
Measured: 1 year
NEI VFQ-25 questionnaire -BCVA (best corrected visual acuity)
Change in BCVA
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 posted2 Oct 2019
- Study start8 Oct 2019
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetamorphopsiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- PD Dr. med. Katja Hatz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, PD Dr. med. Katja Hatz, Vista Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112524
- Sponsor's protocol ID
- Metamorphopsia Study
- Status last verified
- Dec 2021
- First submitted
- 30 Sep 2019
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: when we finished our study (master Thesis) and published (if possible), then we will participant our data
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quantitative Metamorphopsia- Measurements in Patients With mCNV
- ClinicalTrials.gov ID
- NCT04112524
- Acronym / sponsor ID
- Metamorphopsia Study
- Conditions
- Metamorphopsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PD Dr. med. Katja HatzUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 2 Oct 2019 (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 myopic CNV (mCNV) is a blood vessel neoplasm starting from the choroid, based on pathological myopia (severe myopia).
Choroidal neovascularization secondary to pathological myopia is the most common cause of severe visual impairment in myopic patients younger than 50 years old. Because untreated small fibrovascular membranes cause rapid damage to the photoreceptors, timely treatment is required in view of poor spontaneous prognosis1.
Metamorphopsia is the first functional impairment which occurs in mCNV - visual acuity loss and scotoma follow later.
There is a need for better and quicker quantifying of the metamorphopsia in mCNV patients.
The aim of this study is to detect metamorphopsia and verify correlations of different indexes with disease activity or not, measured in Optical Cohorence Tomography (OCT), best corrected visual acuity (BCVA), Vision related quality of life questionnaire (NEI-VFY-25) and quantify severity of metamophopsia.
Detailed description
The myopic CNV is a neovascularization starting from the choroid and growing into the space between choroid and retina, based on pathological myopia (severe myopia). Choroidal neovascularization secondary to pathological myopia (mCNV) is the most common cause of severe visual impairment in myopic patients younger than 50 years old.1 As untreated subretinal fibrovascular membranes cause rapid damage to the photoreceptors, timely treatment is required in view of poor spontaneous prognosis.1
Metamorphopsia is the first functional impairment which occurs in mCNV - visual acuity loss and scotoma follow later. The Amsler Grid, a qualitative paper test developed the swiss ophthalmologist Marc Amsler (1891 - 1968), is a square-shaped grid used to detect or monitor metamorphopsia or scotoma involving the central visual field in various disorders of the macula and optic nerve head11.
Myopic CNV patients use the Amsler Grid as a home monitoring device for qualitative detection of metamorphopsia by checking the grid regularly11. Due to subretinal scarring in mCNV interpretation is often difficult and early changes cannot be detected and quantified. Until now there are no quantitative measurements for mCNV monitoring in clinical use.
Recently, two devices to detect and monitor metamorphopsia using smart phones and PCs, respectively, have been developed for use in choroidal neovascularization in age-related macular degeneration.5,6
- Alleye® Test Alleye® Test is a mobile medical software application indicated for the detection and characterization of metamorphopsia. For the mean Alleye score (±standard deviation (SD) deviations of dots from an ideal line are calculated for each eye.5
- AMD-A Metamorphopsia Detector® Is based on the Amsler grid. The software uses the concept of a negative image: a distorted image can be straightened by moving the mouse. Degree and dimension of distorted lines or scotoma are transformed into indices.6
This study was designed to find out whether these metamorphopsia applications are suitable for patients with mCNV and to find out if mCNV patients can benefit for a quicker detecting of the metamorphopsia.
Therefore, the aim of this study is to detect metamorphopsia and verify correlations of different indexes with disease activity or not, measured in Optical Cohorence Tomography (OCT), best corrected visual Acuity (BCVA), Vision related quality of life questionnaire (NEI-VFY-25) and quantify severity of metamophopsia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients from routine treatment | – | Device: Appall 30 patients from Routine Treatment, only observational |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients in retina- routine control
Key inclusion criteria (5 listed)
- diagnosis of mCNV involving the juxtafoveal or/and foveal region
- BCVA >0.1 (20/200, Snellen)
- ability to follow the study procedures
- given written consent to participation
- >18 years
Key exclusion criteria (3 listed)
- history of vitreoretinal surgery (including membrane peeling and retinal detachment surgery) to the study eye
- presence of macula foramen or epiretinal membrane with significant distortion of retinal architecture
- history of any side effects to Tropicamide eye drops
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 |
|---|---|---|
| App* Alleye® Test Alleye® Test is a mobile medical software application indicated for the detection and characterization of metamorphopsia. For the mean Alleye score (±standard deviation (SD) deviations of dots from an ideal line are calculated for each eye. * AMD-A Metamorphopsia Detector® Is based on the Amsler grid. The software uses the concept of a negative image: a distorted image can be straightened by moving the mouse. Degree and dimension of distorted lines or scotoma are transformed into indices. | Device | Patients from routine treatment |
Primary outcome
Metamorphopsia index change from baseline (no mCNV activity) to month 6 and 12 and all visits in between (disease activity dependent) for the following two devices - AMD-A Metamorphopsia Detector® (app4eyes - TEST) - Alleye® Test
Time frame: 1 year
Metamorphopsia index change (disease activity)
3 secondary outcomes
CRT (central retinal thickness) measured in OCT
Time frame: 1 year
-outer retina disruption score within central 1mm (measured in OCT) -maximum CNV thickness within central 1mm (measured in OCT) -area of pigment epithelium atrophy within central 1mm measured in autofluorescence imaging
Time frame: 1 year
NEI VFQ-25 questionnaire -BCVA (best corrected visual acuity)
Time frame: 1 year
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 9 Dec 2021.
- Individual participant dataSharing planned: Undecided. when we finished our study (master Thesis) and published (if possible), then we will participant our data
Related trials for Metamorphopsia
Recruiting
Virtual Reality Aniseikonia and Metamorphopsia Testing
Metamorphopsia, Aniseikonia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metamorphopsia, run by PD Dr. med. Katja Hatz at 1 site in 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 5 inclusion and 3 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 9 Dec 2021. 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 Switzerland. 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?
Metamorphopsia index change from baseline (no mCNV activity) to month 6 and 12 and all visits in between (disease activity dependent) for the following two devices - AMD-A Metamorphopsia Detector® (app4eyes - TEST) - Alleye® Test (time frame: 1 year). 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 9 Dec 2021.