Epiretinal MembraneNCT04791631
'Distortion as a Predictor of ERM Surgery Outcome'
An observational study of Epiretinal Membrane and Distortion, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Epiretinal membranes (ERM) consist of an abnormal growth of tissue across the retina and are present about 6% of people aged 50 and over. They can cause symptoms of distortion (straight lines appearing bent) or blurred vision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane, Distortion, Quality of Life
- What is being tested?
- Epiretinal membrane surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 1 Apr 2023
- 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 with epiretinal membranes attending the vitreoretinal clinic at the Tennent Institute of Ophthalmology in Glasgow, UK, and meeting the inclusion criteria.
Who may be able to join
- Idiopathic epiretinal membrane
- Patients undergoing vitrectomy and gas surgery, under local or general anaesthetic
- Able to give informed consent
- 18 years old and over
Who cannot join
- Epiretinal membrane secondary to retinal detachment, uveitis or retinal vascular disease
- Previous vitreoretinal surgery
- Pre-existing ophthalmic condition which limits the patient's visual acuity (Documented BCVA 6/36 or worse)
- Pre-existing ophthalmic conditions which cause metamorphopsia (exudative ARMD, central serous retinopathy)
- VA < 6/60
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS Greater Glasgow and Clyde Clinical Research and Development Central Office
Paisley, PA2 7DE
Emma McDonough, Emma.McDonough@ggc.scot.nhs.uk
Lona Jawaheer, MBChB, lonajawaheer@nhs.net
About this study
Official title: Does Pre-operative D-chart Score Predict Improvement in VFQ-25 Score Following Surgery for Epiretinal Membrane?
Epiretinal membranes (ERM) consist of an abnormal growth of tissue across the retina and are present about 6% of people aged 50 and over. They can cause symptoms of distortion (straight lines appearing bent) or blurred vision. Management options include observation if asymptomatic, or surgery to peel the membrane if symptomatic. Limited data exists regarding how to identify patients who are most likely to benefit from surgery.
We propose to measure the effects on distortion (using D chart), visual acuity and vision-related quality of life (using a validated vision-related quality of life questionnaire) of ERM surgery. This will allow us to investigate whether pre-operative D chart score can predict subsequent improvement in quality of life following surgery. We hope the results will help patients and VR surgeons decide whether or not to proceed with ERM surgery.
The study will be a prospective case series consisting of patients with symptomatic epiretinal membranes who choose to have epiretinal membrane surgery. The study participants will get standard care with the additional administration of a quality of life questionnaire and measurement of distortion (using a D-chart) at 3 different time points (pre-op, and post-op at 26 and 52 weeks). Recruitment will be in Glasgow, with a possibility of other sites being added on at a later stage.
Read the detailed description
Epiretinal membranes consist of a proliferation of fibrocellular tissue along the inner aspect of the retina. Over time, this membrane can result in anterior-posterior traction and cause disruption of the retinal architecture, which can lead to symptoms of blurred vision, or distorted vision (with straight lines appearing bent or wavy).
Patients with ERM now constitute one of the most common referrals to the vitreoretinal service. Management of epiretinal membrane includes observation or surgery for severely symptomatic membranes. The surgery consists of vitrectomy and epiretinal +/- inner limiting membrane peel. Currently there is limited evidence to help identify which patients with an epiretinal membrane are the most likely to benefit from this operation, which makes it more difficult for patients to be able to weigh up the benefits and risks of proceeding with this elective procedure.
Our study will measure the effects on distortion (using D chart), visual acuity and quality of life of ERM surgery. Hence it will allow us to investigate whether the pre-op D chart score can predict subsequent improvement in quality of life following surgery. This will provide vitreoretinal surgeons and patients with an evidence base regarding the success of this elective procedure and offer realistic expectations regarding surgical outcomes. Ultimately, we hope that the results of this study will facilitate the decision of whether or not to proceed with ERM surgery.
We plan to recruit patients with an epiretinal membrane who choose to undergo surgery at the time of their clinic appointment within the vitreoretinal service. In addition to standard care, the study participants will undergo measurements of distortion (using a D-chart, duration 5-10 minutes) and fill in a quality of life questionnaire. These measurements will be taken before the operation and at six and twelve months following the operation.
The aims of the study are:
- To investigate the sustained effect of epiretinal membrane surgery on distortion (using D-chart), visual acuity and vision-related quality of life (using NEI VFQ-25 questionnaire)
- To determine the relationship between pre-operative distortion score and post-operative vision-related quality of life score following ERM surgery
Our study will have a larger number of participants with a longer period of follow up (52 weeks) than comparable studies. It will be the first epiretinal membrane study that measures distortion using the D-chart, which we believe to be superior to existing tests (such as the M-chart) which have been used in similar studies.
- Conditions
- Epiretinal Membrane, Distortion, Quality of Life
- Being tested
- Epiretinal membrane surgery
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiretinal membrane surgeryProcedure or surgery
Surgery for epiretinal membrane i.e. standard 3-port pars plana vitrectomy and epiretinal membrane and internal limiting membrane peel. Phakic patients will undergo cataract surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
VFQ-25 score at final visit (52 weeks after ERM surgery)
Measure of vision-related quality of life using NEI VFQ-25 quality of life questionnaire, 1 year after surgery for epiretinal membrane
Measured: 1 year
Secondary outcomes (4)
Distortion score pre-operatively and at 26 and 52 weeks after ERM surgery
Distortion score calculated using D-chart
Measured: 1 year
Best-corrected visual acuity pre-operatively and at 26 and 52 weeks after ERM surgery
Visual acuity measured in ETDRS
Measured: 1 year
Vision-related quality of life pre-operatively and at 26 and 52 weeks after ERM surgery
Vision-related quality of life assessed using NEI VFQ-25 quality of life questionnaire
Measured: 1 year
Central retinal thickness pre-operatively and at 26 and 52 weeks after ERM surgery
Central retinal thickness obtained from OCT scans done in clinic
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 posted10 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Epiretinal MembraneStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Lona Jawaheer, MBChB, Principal investigator, NHS Greater Glasgow and ClydeDavid Yorston, MBChb, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791631
- Sponsor's protocol ID
- GN18OP439
- Status last verified
- Mar 2021
- First submitted
- 9 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dawson SR, Shunmugam M, Williamson TH. Visual acuity outcomes following surgery for idiopathic epiretinal membrane: an analysis of data from 2001 to 2011. Eye (Lond). 2014 Feb;28(2):219-24. doi: 10.1038/eye.2013.253. Epub 2013 Dec 6.
PubMed 24310238Wong JG, Sachdev N, Beaumont PE, Chang AA. Visual outcomes following vitrectomy and peeling of epiretinal membrane. Clin Exp Ophthalmol. 2005 Aug;33(4):373-8. doi: 10.1111/j.1442-9071.2005.01025.x.
PubMed 16033349Pournaras CJ, Emarah A, Petropoulos IK. Idiopathic macular epiretinal membrane surgery and ILM peeling: anatomical and functional outcomes. Semin Ophthalmol. 2011 Mar;26(2):42-6. doi: 10.3109/08820538.2010.544237.
PubMed 21469962Rahman R, Stephenson J. Early surgery for epiretinal membrane preserves more vision for patients. Eye (Lond). 2014 Apr;28(4):410-4. doi: 10.1038/eye.2013.305. Epub 2014 Jan 10.
PubMed 24406414Ghazi-Nouri SM, Tranos PG, Rubin GS, Adams ZC, Charteris DG. Visual function and quality of life following vitrectomy and epiretinal membrane peel surgery. Br J Ophthalmol. 2006 May;90(5):559-62. doi: 10.1136/bjo.2005.085142. Epub 2006 Jan 18.
PubMed 16421185Ichikawa Y, Imamura Y, Ishida M. Associations of aniseikonia with metamorphopsia and retinal displacements after epiretinal membrane surgery. Eye (Lond). 2018 Feb;32(2):400-405. doi: 10.1038/eye.2017.201. Epub 2017 Sep 22.
PubMed 28937146Kinoshita T, Imaizumi H, Miyamoto H, Okushiba U, Hayashi Y, Katome T, Mitamura Y. Changes in metamorphopsia in daily life after successful epiretinal membrane surgery and correlation with M-CHARTS score. Clin Ophthalmol. 2015 Feb 4;9:225-33. doi: 10.2147/OPTH.S76847. eCollection 2015.
PubMed 25678770Okamoto F, Okamoto Y, Hiraoka T, Oshika T. Effect of vitrectomy for epiretinal membrane on visual function and vision-related quality of life. Am J Ophthalmol. 2009 May;147(5):869-74, 874.e1. doi: 10.1016/j.ajo.2008.11.018. Epub 2009 Feb 6.
PubMed 19200531McGowan G, Yorston D, Strang NC, Manahilov V. D-CHART: A Novel Method of Measuring Metamorphopsia in Epiretinal Membrane and Macular Hole. Retina. 2016 Apr;36(4):703-8. doi: 10.1097/IAE.0000000000000778.
PubMed 26441261Klein R, Moss SE, Klein BE, Gutierrez P, Mangione CM. The NEI-VFQ-25 in people with long-term type 1 diabetes mellitus: the Wisconsin Epidemiologic Study of Diabetic Retinopathy. Arch Ophthalmol. 2001 May;119(5):733-40. doi: 10.1001/archopht.119.5.733.
PubMed 11346401Nichols KK, Mitchell GL, Zadnik K. Performance and repeatability of the NEI-VFQ-25 in patients with dry eye. Cornea. 2002 Aug;21(6):578-83. doi: 10.1097/00003226-200208000-00009.
PubMed 12131034Orr P, Rentz AM, Margolis MK, Revicki DA, Dolan CM, Colman S, Fine JT, Bressler NM. Validation of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3354-9. doi: 10.1167/iovs.10-5645.
PubMed 21282568Owen CG, Rudnicka AR, Smeeth L, Evans JR, Wormald RP, Fletcher AE. Is the NEI-VFQ-25 a useful tool in identifying visual impairment in an elderly population? BMC Ophthalmol. 2006 Jun 9;6:24. doi: 10.1186/1471-2415-6-24.
PubMed 16764714
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pre-operative D-chart Score Predict Improvement in VFQ-25 Score Following Surgery for Epiretinal Membrane?
- ClinicalTrials.gov ID
- NCT04791631
- Acronym / sponsor ID
- GN18OP439
- Conditions
- Epiretinal Membrane, Distortion, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Royal College of Surgeons of Edinburgh
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 10 Mar 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.
Epiretinal membranes (ERM) consist of an abnormal growth of tissue across the retina and are present about 6% of people aged 50 and over. They can cause symptoms of distortion (straight lines appearing bent) or blurred vision. Management options include observation if asymptomatic, or surgery to peel the membrane if symptomatic. Limited data exists regarding how to identify patients who are most likely to benefit from surgery.
We propose to measure the effects on distortion (using D chart), visual acuity and vision-related quality of life (using a validated vision-related quality of life questionnaire) of ERM surgery. This will allow us to investigate whether pre-operative D chart score can predict subsequent improvement in quality of life following surgery. We hope the results will help patients and VR surgeons decide whether or not to proceed with ERM surgery.
The study will be a prospective case series consisting of patients with symptomatic epiretinal membranes who choose to have epiretinal membrane surgery. The study participants will get standard care with the additional administration of a quality of life questionnaire and measurement of distortion (using a D-chart) at 3 different time points (pre-op, and post-op at 26 and 52 weeks). Recruitment will be in Glasgow, with a possibility of other sites being added on at a later stage.
Detailed description
Epiretinal membranes consist of a proliferation of fibrocellular tissue along the inner aspect of the retina. Over time, this membrane can result in anterior-posterior traction and cause disruption of the retinal architecture, which can lead to symptoms of blurred vision, or distorted vision (with straight lines appearing bent or wavy).
Patients with ERM now constitute one of the most common referrals to the vitreoretinal service. Management of epiretinal membrane includes observation or surgery for severely symptomatic membranes. The surgery consists of vitrectomy and epiretinal +/- inner limiting membrane peel. Currently there is limited evidence to help identify which patients with an epiretinal membrane are the most likely to benefit from this operation, which makes it more difficult for patients to be able to weigh up the benefits and risks of proceeding with this elective procedure.
Our study will measure the effects on distortion (using D chart), visual acuity and quality of life of ERM surgery. Hence it will allow us to investigate whether the pre-op D chart score can predict subsequent improvement in quality of life following surgery. This will provide vitreoretinal surgeons and patients with an evidence base regarding the success of this elective procedure and offer realistic expectations regarding surgical outcomes. Ultimately, we hope that the results of this study will facilitate the decision of whether or not to proceed with ERM surgery.
We plan to recruit patients with an epiretinal membrane who choose to undergo surgery at the time of their clinic appointment within the vitreoretinal service. In addition to standard care, the study participants will undergo measurements of distortion (using a D-chart, duration 5-10 minutes) and fill in a quality of life questionnaire. These measurements will be taken before the operation and at six and twelve months following the operation.
The aims of the study are:
- To investigate the sustained effect of epiretinal membrane surgery on distortion (using D-chart), visual acuity and vision-related quality of life (using NEI VFQ-25 questionnaire)
- To determine the relationship between pre-operative distortion score and post-operative vision-related quality of life score following ERM surgery
Our study will have a larger number of participants with a longer period of follow up (52 weeks) than comparable studies. It will be the first epiretinal membrane study that measures distortion using the D-chart, which we believe to be superior to existing tests (such as the M-chart) which have been used in similar studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with epiretinal membranes attending the vitreoretinal clinic at the Tennent Institute of Ophthalmology in Glasgow, UK, and meeting the inclusion criteria.
Key inclusion criteria (4 listed)
- Idiopathic epiretinal membrane
- Patients undergoing vitrectomy and gas surgery, under local or general anaesthetic
- Able to give informed consent
- 18 years old and over
Key exclusion criteria (5 listed)
- Epiretinal membrane secondary to retinal detachment, uveitis or retinal vascular disease
- Previous vitreoretinal surgery
- Pre-existing ophthalmic condition which limits the patient's visual acuity (Documented BCVA 6/36 or worse)
- Pre-existing ophthalmic conditions which cause metamorphopsia (exudative ARMD, central serous retinopathy)
- VA < 6/60
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 |
|---|---|---|
| Epiretinal membrane surgerySurgery for epiretinal membrane i.e. standard 3-port pars plana vitrectomy and epiretinal membrane and internal limiting membrane peel. Phakic patients will undergo cataract surgery. | Procedure or surgery | – |
Primary outcome
VFQ-25 score at final visit (52 weeks after ERM surgery)
Time frame: 1 year
Measure of vision-related quality of life using NEI VFQ-25 quality of life questionnaire, 1 year after surgery for epiretinal membrane
4 secondary outcomes
Distortion score pre-operatively and at 26 and 52 weeks after ERM surgery
Time frame: 1 year
Best-corrected visual acuity pre-operatively and at 26 and 52 weeks after ERM surgery
Time frame: 1 year
Vision-related quality of life pre-operatively and at 26 and 52 weeks after ERM surgery
Time frame: 1 year
Central retinal thickness pre-operatively and at 26 and 52 weeks after ERM surgery
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 10 Mar 2021.
- Background: PubMed 24310238Dawson SR, Shunmugam M, Williamson TH. Visual acuity outcomes following surgery for idiopathic epiretinal membrane: an analysis of data from 2001 to 2011. Eye (Lond). 2014 Feb;28(2):219-24. doi: 10.1038/eye.2013.253. Epub 2013 Dec 6.
- Background: PubMed 16033349Wong JG, Sachdev N, Beaumont PE, Chang AA. Visual outcomes following vitrectomy and peeling of epiretinal membrane. Clin Exp Ophthalmol. 2005 Aug;33(4):373-8. doi: 10.1111/j.1442-9071.2005.01025.x.
- Background: PubMed 21469962Pournaras CJ, Emarah A, Petropoulos IK. Idiopathic macular epiretinal membrane surgery and ILM peeling: anatomical and functional outcomes. Semin Ophthalmol. 2011 Mar;26(2):42-6. doi: 10.3109/08820538.2010.544237.
- Background: PubMed 24406414Rahman R, Stephenson J. Early surgery for epiretinal membrane preserves more vision for patients. Eye (Lond). 2014 Apr;28(4):410-4. doi: 10.1038/eye.2013.305. Epub 2014 Jan 10.
- Background: PubMed 16421185Ghazi-Nouri SM, Tranos PG, Rubin GS, Adams ZC, Charteris DG. Visual function and quality of life following vitrectomy and epiretinal membrane peel surgery. Br J Ophthalmol. 2006 May;90(5):559-62. doi: 10.1136/bjo.2005.085142. Epub 2006 Jan 18.
- Background: PubMed 28937146Ichikawa Y, Imamura Y, Ishida M. Associations of aniseikonia with metamorphopsia and retinal displacements after epiretinal membrane surgery. Eye (Lond). 2018 Feb;32(2):400-405. doi: 10.1038/eye.2017.201. Epub 2017 Sep 22.
- Background: PubMed 25678770Kinoshita T, Imaizumi H, Miyamoto H, Okushiba U, Hayashi Y, Katome T, Mitamura Y. Changes in metamorphopsia in daily life after successful epiretinal membrane surgery and correlation with M-CHARTS score. Clin Ophthalmol. 2015 Feb 4;9:225-33. doi: 10.2147/OPTH.S76847. eCollection 2015.
- Background: PubMed 19200531Okamoto F, Okamoto Y, Hiraoka T, Oshika T. Effect of vitrectomy for epiretinal membrane on visual function and vision-related quality of life. Am J Ophthalmol. 2009 May;147(5):869-74, 874.e1. doi: 10.1016/j.ajo.2008.11.018. Epub 2009 Feb 6.
- Background: PubMed 26441261McGowan G, Yorston D, Strang NC, Manahilov V. D-CHART: A Novel Method of Measuring Metamorphopsia in Epiretinal Membrane and Macular Hole. Retina. 2016 Apr;36(4):703-8. doi: 10.1097/IAE.0000000000000778.
- Background: PubMed 11346401Klein R, Moss SE, Klein BE, Gutierrez P, Mangione CM. The NEI-VFQ-25 in people with long-term type 1 diabetes mellitus: the Wisconsin Epidemiologic Study of Diabetic Retinopathy. Arch Ophthalmol. 2001 May;119(5):733-40. doi: 10.1001/archopht.119.5.733.
- Background: PubMed 12131034Nichols KK, Mitchell GL, Zadnik K. Performance and repeatability of the NEI-VFQ-25 in patients with dry eye. Cornea. 2002 Aug;21(6):578-83. doi: 10.1097/00003226-200208000-00009.
- Background: PubMed 21282568Orr P, Rentz AM, Margolis MK, Revicki DA, Dolan CM, Colman S, Fine JT, Bressler NM. Validation of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3354-9. doi: 10.1167/iovs.10-5645.
- Individual participant dataSharing planned: No
Related trials for Epiretinal Membrane
Recruiting
Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
Epiretinal Membrane
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
OCT Macula Biomarkers Before Silicone Oil Removal and Visual Outcome After Silicone Oil Removal
Retinal Detachment, Macular Edema
Recruiting
(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
Epiretinal Membrane, Dry Age Related Macular Degeneration
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.
Lona Jawaheer, MBChB principal investigator
NHS Greater Glasgow and Clyde
David Yorston, MBChb principal investigator
NHS Greater Glasgow and Clyde
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 Epiretinal Membrane and Distortion, run by NHS Greater Glasgow and Clyde 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 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 10 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma McDonough (+44141 314 4000, Emma.McDonough@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VFQ-25 score at final visit (52 weeks after ERM surgery) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791631, which also lists 13 linked publications.
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 10 Mar 2021.