Retinitis PigmentosaNCT03626207
Development of Visual Function Evaluation Method (2)
An observational study of Retinitis Pigmentosa, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- 4 Oct 2018to 26 Jun 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Retinitis pigmentosa
Who may be able to join
- Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent and at screening
Who cannot join
- Subjects should not have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
- History of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study
- Pregnant women
- Subjects who are judged that continuation of the study is difficult during the study period
- Subjects who are employed by the company sponsoring this study, an organization or institution related to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient.
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis pigmentosa, Visual function evaluation
- Medical subject headings
- Retinitis Pigmentosa
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 |
|---|---|---|
| Retinitis pigmentosa | Retinitis pigmentosa patients with severe visual impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit-lamp-microscopy
To assess the visual function.
Measured: Up to 3 months
Optical Coherence Tomography (OCT) test
To assess the visual function.
Measured: Day 1
Early Treatment Diabetic Retinopathy Study (ETDRS)
To assess the visual function.
Measured: Up to 3 months
The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25)
NEI VFQ 25 is a questionnaire intended to measure visual function and quality of life. It has 25 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (worst) to 100 (best).
Measured: Up to 3 months
The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11)
NEI VFQ 11 is a questionnaire intended to measure visual function and quality of life. It has 11 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (worst) to 100 (best).
Measured: Up to 3 months
Nottingham Adjustment Scale Japanese Version (NAS-J)
NAS-J is the Japanese version of NAS which measures psychological adjustment to the visual impairment, and to assess its validity and reliability. The NAS is composed of 7 psychological subscales including anxiety-depression, self-esteem, attitude to disability, locus of control, acceptance of disability, self-efficacy and attributional style. The original response of each item are coded as per the NAS-J scoring system ranging from 0 (lowest psychological adjustment) to 100 (highest psychological adjustment).
Measured: Up to 3 months
Daily living task dependent on vision (DLTV) questionnaire
DLTV is a quality of life questionnaire composed of 22 items to obtain estimates of self-reported ability to perform vision-related tasks in persons with visual impairment. Participants rate items on a four-point scale, with "Can't see to do" (score, 1), "A lot of difficulty" (score, 2), "A little difficulty" (score, 3), and"No difficulty" (score, 4). The original response of each item are coded as per the DLTV scoring system ranging from 0 (worst) to 100 (best).
Measured: Up to 3 months
Table test
To assess the visual function.
Measured: Up to 3 months
Monitor test
To assess the visual function.
Measured: Up to 3 months
Pupillary function test
To assess the visual function.
Measured: Up to 3 months
Full field stimulus threshold testing (FST)
To assess the visual function.
Measured: Up to 3 months
White flash visual evoked potential (VEP) test
To assess the visual function.
Measured: Up to 3 months
Color flash VEP test
To assess the visual function.
Measured: Up to 3 months
Electrically evoked response (EER) test
To assess the visual function.
Measured: Up to 3 months
White flash Electroretinography (ERG) test
To assess the visual function.
Measured: Day 1
Multifocal ERG test
To assess the visual function.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start4 Oct 2018
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626207
- Sponsor's protocol ID
- CLR180001
- Status last verified
- Jul 2019
- First submitted
- 8 Aug 2018
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss
- ClinicalTrials.gov ID
- NCT03626207
- Acronym / sponsor ID
- CLR180001
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis pigmentosa, Visual function evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 10 Aug 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 objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinitis pigmentosa | – | –Retinitis pigmentosa patients with severe visual impairment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retinitis pigmentosa
Key inclusion criteria (1 listed)
- Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent and at screening
Key exclusion criteria (5 listed)
- Subjects should not have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
- History of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study
- Pregnant women
- Subjects who are judged that continuation of the study is difficult during the study period
- Subjects who are employed by the company sponsoring this study, an organization or institution related to this study
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
Slit-lamp-microscopy
Time frame: Up to 3 months
To assess the visual function.
Optical Coherence Tomography (OCT) test
Time frame: Day 1
To assess the visual function.
Early Treatment Diabetic Retinopathy Study (ETDRS)
Time frame: Up to 3 months
To assess the visual function.
The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25)
Time frame: Up to 3 months
NEI VFQ 25 is a questionnaire intended to measure visual function and quality of life. It has 25 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (worst) to 100 (best).
The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11)
Time frame: Up to 3 months
NEI VFQ 11 is a questionnaire intended to measure visual function and quality of life. It has 11 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (worst) to 100 (best).
Nottingham Adjustment Scale Japanese Version (NAS-J)
Time frame: Up to 3 months
NAS-J is the Japanese version of NAS which measures psychological adjustment to the visual impairment, and to assess its validity and reliability. The NAS is composed of 7 psychological subscales including anxiety-depression, self-esteem, attitude to disability, locus of control, acceptance of disability, self-efficacy and attributional style. The original response of each item are coded as per the NAS-J scoring system ranging from 0 (lowest psychological adjustment) to 100 (highest psychological adjustment).
Daily living task dependent on vision (DLTV) questionnaire
Time frame: Up to 3 months
DLTV is a quality of life questionnaire composed of 22 items to obtain estimates of self-reported ability to perform vision-related tasks in persons with visual impairment. Participants rate items on a four-point scale, with "Can't see to do" (score, 1), "A lot of difficulty" (score, 2), "A little difficulty" (score, 3), and"No difficulty" (score, 4). The original response of each item are coded as per the DLTV scoring system ranging from 0 (worst) to 100 (best).
Table test
Time frame: Up to 3 months
To assess the visual function.
Monitor test
Time frame: Up to 3 months
To assess the visual function.
Pupillary function test
Time frame: Up to 3 months
To assess the visual function.
Full field stimulus threshold testing (FST)
Time frame: Up to 3 months
To assess the visual function.
White flash visual evoked potential (VEP) test
Time frame: Up to 3 months
To assess the visual function.
Color flash VEP test
Time frame: Up to 3 months
To assess the visual function.
Electrically evoked response (EER) test
Time frame: Up to 3 months
To assess the visual function.
White flash Electroretinography (ERG) test
Time frame: Day 1
To assess the visual function.
Multifocal ERG test
Time frame: Up to 3 months
To assess the visual function.
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 21 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Director study director
Astellas Pharma Inc
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 Retinitis Pigmentosa, run by Astellas Pharma Inc at 1 site in Japan.
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 1 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: finished, as of the sponsor's last update on 21 Oct 2024. 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 Japan. 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?
Slit-lamp-microscopy (time frame: Up to 3 months). The study lists 16 primary outcomes in all. 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 2024.