Retinal DegenerationNCT02814435
Quality of Life Measures in Patients With Retinal Degeneration
An observational study of Retinal Degeneration, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Inherited retinal degeneration (IRD) is a major cause of blindness and partial loss of vision cases in the UK and starts at an early age. The purpose of this observational study is to use the results of two questionnaires and a computerised test testing contrast sensitivity, to assess the impact of IRD on quality of… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Degeneration
- What is being tested?
- Questionnaire and Computerised contrast sensitivity function test
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Oct 2017
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60 patients with inherited retinal degeneration will be recruited from the outpatient clinic in the Oxford Eye Hospital. 30 healthy controls will be recruited from advertising around the OUH hospitals and the University of Oxford.
Who may be able to join
- Participant is willing \& able to give informed consent for participation in the study.
- Male or female, aged 18 - 85.
- A clinical or genetic diagnosis of retinal degeneration or normal age and sex-matched controls without known retinal disease.
- Able to participate in visual function testing.
Who cannot join
- The participant may not enter the study if any of the following apply:
- 1) they have a pre-existing amblyopia or squint;
- 2) they have any other retinal problems that may confound the measures assessed.
Trial locations and contacts
1 site in 1 country.
About this study
Inherited retinal degeneration (IRD) is a major cause of blindness and partial loss of vision cases in the UK and starts at an early age. The purpose of this observational study is to use the results of two questionnaires and a computerised test testing contrast sensitivity, to assess the impact of IRD on quality of life. This study will involve collecting data from patients with IRD, but also collecting data from normal controls.
Read the detailed description
IRD presents a significant burden on the NHS as well as on the individual and families. IRDs are particularly difficult in a family situation due to guilt and other complex emotions related to inheritance patterns. Poorer mental health has been reported in patients with retinitis pigmentosa, manifesting in a range of ways including stress, depression and anxiety, particularly as the disease progresses. This is most probably caused by the uncertainty of the disease process and the progressive nature of the degeneration.
Recent work has reported that quality of life significantly deteriorates with a drop in visual field diameter of 20 degrees or a drop in visual acuity lower then LogMAR 0.3 (equivalent to 6/12). Contrast sensitivity is often used in conjunction with VA to assess visual capabilities. It is a measure of the ability to see reduced contrast and has a major impact on utility of vision. Relating contrast sensitivity function to quality of life will provide valuable information about whether this aspect of vision is a critical measure for patient health. This is especially important as novel treatments are being developed for the treatment of IRDs.
- Conditions
- Retinal Degeneration
- Being tested
- Questionnaire, Computerised contrast sensitivity function test
- Keywords
- Retina, Retinal Degeneration, Quality of Life Measures
- Medical subject headings
- Retinal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The participants will answer two questionnaires. These are the NEI VFQ-25 and the DLTV (daily living tasks of vision).
Computerised contrast sensitivity function testOther
This test involves the patient identifying whether bars on a screen are horizontal or vertical. It is designed to measure contrast sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with inherited retinal degeneration will answer two questionnaires and undergo a computerised contrast sensitivity function test. Receives: Other: Questionnaire; Other: Computerised contrast sensitivity function test | |
| Normal controls | Normal controls recruited by advertising will answer two questionnaires and undergo a computerised test that assess contrast sensitivity function. Receives: Other: Questionnaire; Other: Computerised contrast sensitivity function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of inherited retinal degeneration on quality of life measures.
This will be assessed by comparing questionnaire results between different inherited retinal degeneration types.This will be determined by using ANOVA testing to compare scores caused by different genetic mutations, allowing us to relate mutations causing central versus peripheral visual loss to the quality of life measures.
Measured: May 2016 to May 2017
Secondary outcomes (1)
Effect of contrast sensitivity function on quality of life.
Contrast sensitivity function will be related to the questionnaire results using ANOVA testing \& correlation analysis.
Measured: May 2016 to May 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DegenerationStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasleen K Jolly, MSc, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814435
- Sponsor's protocol ID
- QoLMeasuresIRD
- Status last verified
- Nov 2018
- First submitted
- 23 Jun 2016
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Measures in Patients With Retinal Degeneration
- ClinicalTrials.gov ID
- NCT02814435
- Acronym / sponsor ID
- QoLMeasuresIRD
- Conditions
- Retinal Degeneration
- Keywords
- Retina, Retinal Degeneration, Quality of Life Measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 27 Jun 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.
Inherited retinal degeneration (IRD) is a major cause of blindness and partial loss of vision cases in the UK and starts at an early age. The purpose of this observational study is to use the results of two questionnaires and a computerised test testing contrast sensitivity, to assess the impact of IRD on quality of life. This study will involve collecting data from patients with IRD, but also collecting data from normal controls.
Detailed description
IRD presents a significant burden on the NHS as well as on the individual and families. IRDs are particularly difficult in a family situation due to guilt and other complex emotions related to inheritance patterns. Poorer mental health has been reported in patients with retinitis pigmentosa, manifesting in a range of ways including stress, depression and anxiety, particularly as the disease progresses. This is most probably caused by the uncertainty of the disease process and the progressive nature of the degeneration.
Recent work has reported that quality of life significantly deteriorates with a drop in visual field diameter of 20 degrees or a drop in visual acuity lower then LogMAR 0.3 (equivalent to 6/12). Contrast sensitivity is often used in conjunction with VA to assess visual capabilities. It is a measure of the ability to see reduced contrast and has a major impact on utility of vision. Relating contrast sensitivity function to quality of life will provide valuable information about whether this aspect of vision is a critical measure for patient health. This is especially important as novel treatments are being developed for the treatment of IRDs.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Questionnaire, Other: Computerised contrast sensitivity function testPatients with inherited retinal degeneration will answer two questionnaires and undergo a computerised contrast sensitivity function test. |
| Normal controls | – | Other: Questionnaire, Other: Computerised contrast sensitivity function testNormal controls recruited by advertising will answer two questionnaires and undergo a computerised test that assess contrast sensitivity function. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients with inherited retinal degeneration will be recruited from the outpatient clinic in the Oxford Eye Hospital. 30 healthy controls will be recruited from advertising around the OUH hospitals and the University of Oxford.
Key inclusion criteria (4 listed)
- Participant is willing \& able to give informed consent for participation in the study.
- Male or female, aged 18 - 85.
- A clinical or genetic diagnosis of retinal degeneration or normal age and sex-matched controls without known retinal disease.
- Able to participate in visual function testing.
Key exclusion criteria (3 listed)
- The participant may not enter the study if any of the following apply:
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 |
|---|---|---|
| QuestionnaireThe participants will answer two questionnaires. These are the NEI VFQ-25 and the DLTV (daily living tasks of vision). | Other | Normal controls, Patients |
| Computerised contrast sensitivity function testThis test involves the patient identifying whether bars on a screen are horizontal or vertical. It is designed to measure contrast sensitivity. | Other | Normal controls, Patients |
Primary outcome
Impact of inherited retinal degeneration on quality of life measures.
Time frame: May 2016 to May 2017
This will be assessed by comparing questionnaire results between different inherited retinal degeneration types.This will be determined by using ANOVA testing to compare scores caused by different genetic mutations, allowing us to relate mutations causing central versus peripheral visual loss to the quality of life measures.
1 secondary outcome
Effect of contrast sensitivity function on quality of life.
Time frame: May 2016 to May 2017
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 13 Nov 2018.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Jasleen K Jolly, MSc principal investigator
University of Oxford
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 Retinal Degeneration, run by University of Oxford at 1 site in United Kingdom.
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 4 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 13 Nov 2018. 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 United Kingdom. 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?
Impact of inherited retinal degeneration on quality of life measures. (time frame: May 2016 to May 2017). 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 13 Nov 2018.