Ophthalmologic ComplicationMQUESTNCT05171621
Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
An observational study of Ophthalmologic Complication and Epiretinal Membrane, run by Hayley Westwood at 1 site in United Kingdom.
Trial summary
Assessing metamorphopsia and quality of vision pre and post epiretinal and macular hole surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ophthalmologic Complication, Epiretinal Membrane, Metamorphopsia
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2019to 31 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have epiretinal membranes or macular holes and have been listed for a vitrectomy
Who may be able to join
- Participant is willing and able to give informed consent
- >18 years old
- Patients listed for epi retinal and macular hole surgery
- Patient is able to perform study procedures
Who cannot join
- Patients who are diagnosed with a condition other than epiretinal membrane or macular hole
- Patients not undergoing epiretinal or macular hole surgery
- Patients will be excluded if there are any complications within surgery, or undergo any procedures that is not an epiretinal or macular hole surgery (i.e vitrectomy, phacoemulsification (lens extraction) as this can affect visual outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Assessing metamorphopsia and quality of vision pre and post epiretinal and macular hole surgery
Read the detailed description
Metamorphopsia is a visual symptom in which straight lines appear distorted, for example a vertical window blind may appear wavy which can affect quality of vision. Metamorphopsia is a common symptom in retinal conditions such as epiretinal membranes (ERM) and macular holes. There is a lack of studies analysing the prevalence of ERM in the UK and Europe.
Both of the conditions have shown to be a higher risk factor with age. With an aging population it is likely these numbers will increase. Currently the only treatment option is surgery (vitrectomy) or conservative management to monitor the condition. It would therefore be beneficial to find a tool that would inform the surgeon of a patient's quality of vision and how this impacts their life. A patient's severity of metamorphopsia reveals more precise information on the progression of the disease than visual acuity alone (Nomoto et al. 2013) therefore gaining a better understanding can help aid clinical decisions.
Current clinical practice is to monitor metamorphopsia with an Amsler chart, a grid with lines; the patient is then asked to draw where they can see distortion. They are used to detect metamorphopsia but are unable to quantify and provide an accurate measurement of the severity of metamorphopsia and quality of vision
The Quality of Vision questionnaire (QoV) (McAlinden et al. 2010) is a modern tool developed to specifically measure subjective quality of vision. The Metamorphopsia questionnaire (Arimura et al. 2011) has been developed to provide a measurement of subjective metamorphopsia in macular disease. Both have been psychometrically validated and are in use in a number of clinical trials worldwide.
It would be valuable to investigate the role of each questionnaire in identifying quality of vison and metamorphopsia pre- and post-surgery for ERM and macular holes to establish if there are changes to patient responses. We would compare this to visual acuity and optical coherence tomography (OCT) images pre- and post-surgery to see if changes correspond to the questionnaire responses. If a questionnaire can measure metamorphopsia and its impact on quality of vision in ERM and macular holes, this would assist in clinical decision making.
- Medical subject headings
- Epiretinal Membrane, Vision Disorders, Retinal Perforations
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 |
|---|---|---|
| Macular holes | Not described | |
| Epiretinal membranes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the responses of the McAllinden and Metamorphopsia Questionnaire
analysing changes to responses in the 2 questionnaires pre and post surgery
Measured: pre surgery and 2 - 3 months post surgery
Secondary outcomes (1)
Changes to BCVA score
Patients BCVA pre and post surgery to see if there is an improvement
Measured: Pre surgery and 2-3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start16 Oct 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmologic ComplicationStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hayley Westwood
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hayley Westwood, University Hospital of Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171621
- Sponsor's protocol ID
- 18/NOV/7557
- Acronym
- MQUEST
- Status last verified
- Dec 2021
- First submitted
- 25 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- 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 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
- ClinicalTrials.gov ID
- NCT05171621
- Acronym / sponsor ID
- MQUEST / 18/NOV/7557
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hayley WestwoodUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 29 Dec 2021 (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.
Assessing metamorphopsia and quality of vision pre and post epiretinal and macular hole surgery
Detailed description
Metamorphopsia is a visual symptom in which straight lines appear distorted, for example a vertical window blind may appear wavy which can affect quality of vision. Metamorphopsia is a common symptom in retinal conditions such as epiretinal membranes (ERM) and macular holes. There is a lack of studies analysing the prevalence of ERM in the UK and Europe.
Both of the conditions have shown to be a higher risk factor with age. With an aging population it is likely these numbers will increase. Currently the only treatment option is surgery (vitrectomy) or conservative management to monitor the condition. It would therefore be beneficial to find a tool that would inform the surgeon of a patient's quality of vision and how this impacts their life. A patient's severity of metamorphopsia reveals more precise information on the progression of the disease than visual acuity alone (Nomoto et al. 2013) therefore gaining a better understanding can help aid clinical decisions.
Current clinical practice is to monitor metamorphopsia with an Amsler chart, a grid with lines; the patient is then asked to draw where they can see distortion. They are used to detect metamorphopsia but are unable to quantify and provide an accurate measurement of the severity of metamorphopsia and quality of vision
The Quality of Vision questionnaire (QoV) (McAlinden et al. 2010) is a modern tool developed to specifically measure subjective quality of vision. The Metamorphopsia questionnaire (Arimura et al. 2011) has been developed to provide a measurement of subjective metamorphopsia in macular disease. Both have been psychometrically validated and are in use in a number of clinical trials worldwide.
It would be valuable to investigate the role of each questionnaire in identifying quality of vison and metamorphopsia pre- and post-surgery for ERM and macular holes to establish if there are changes to patient responses. We would compare this to visual acuity and optical coherence tomography (OCT) images pre- and post-surgery to see if changes correspond to the questionnaire responses. If a questionnaire can measure metamorphopsia and its impact on quality of vision in ERM and macular holes, this would assist in clinical decision making.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macular holes | – | – |
| Epiretinal membranes | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have epiretinal membranes or macular holes and have been listed for a vitrectomy
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent
- >18 years old
- Patients listed for epi retinal and macular hole surgery
- Patient is able to perform study procedures
Key exclusion criteria (3 listed)
- Patients who are diagnosed with a condition other than epiretinal membrane or macular hole
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
Compare the responses of the McAllinden and Metamorphopsia Questionnaire
Time frame: pre surgery and 2 - 3 months post surgery
analysing changes to responses in the 2 questionnaires pre and post surgery
1 secondary outcome
Changes to BCVA score
Time frame: Pre surgery and 2-3 months post surgery
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 29 Dec 2021.
- Individual participant dataSharing planned: No
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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.
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 Ophthalmologic Complication and Epiretinal Membrane, run by Hayley Westwood 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 29 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 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?
Compare the responses of the McAllinden and Metamorphopsia Questionnaire (time frame: pre surgery and 2 - 3 months post surgery). 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 29 Dec 2021.