Epiretinal MembraneNCT03661593
Aniseikonia in Epiretinal Membrane Patients
A study testing Cataract guideline in people with Epiretinal Membrane, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Examination of aniseikonia in epiretinal membranes patients before and after surgery Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- Cataract guideline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2017to Nov 2019
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Epiretinal membrane Phakic on both eyes
Who cannot join
- no previous eye surgeries
- refractive status +/- 2 seq
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Eye department, Nordre ringvej 56
Copenhagen, Glostrup, 2600
Therese Krarup, MD, +45 38633963, theresekrarup@gmail.com
About this study
Official title: Aniseikonia in Epiretinal Membranes
Examination of aniseikonia in epiretinal membranes patients before and after surgery
Read the detailed description
Phakic patients woth epiretinal membranes are examined for aniseikonia and refractive status before and after surgery. Follow up is one year.
- Conditions
- Epiretinal Membrane
- Being tested
- Cataract guideline
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract guidelineOther
The patients gets an IOL according to cataract guideline correcting the ametropia
| Study group | Role | What they receive |
|---|---|---|
| Cataract guideline | Experimental | In this patients we follow cataract guideline and correct the patients ametropia during the cataract surgery Receives: Other: Cataract guideline |
| Standard refraction | No intervention | The patients gets an IOL ensuring his preoperatively refraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aniseikonia
Measure amount of aniseikonia by measuring aniseikonia with both computer program aniseikonia inspector and the New Aniseikonia test
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 posted7 Sep 2018
- Study start1 Nov 2017
- Primary completionJan 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Therese Krarup, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661593
- Sponsor's protocol ID
- H-16020057
- Status last verified
- Sep 2018
- First submitted
- 31 Aug 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No planing on sharing
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aniseikonia in Epiretinal Membranes
- ClinicalTrials.gov ID
- NCT03661593
- Acronym / sponsor ID
- H-16020057
- Conditions
- Epiretinal Membrane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 7 Sep 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.
Examination of aniseikonia in epiretinal membranes patients before and after surgery
Detailed description
Phakic patients woth epiretinal membranes are examined for aniseikonia and refractive status before and after surgery. Follow up is one year.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cataract guideline | Experimental | Other: Cataract guidelineIn this patients we follow cataract guideline and correct the patients ametropia during the cataract surgery |
| Standard refraction | No intervention | –The patients gets an IOL ensuring his preoperatively refraction |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Epiretinal membrane Phakic on both eyes
Key exclusion criteria (2 listed)
- no previous eye surgeries
- refractive status +/- 2 seq
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 |
|---|---|---|
| Cataract guidelineThe patients gets an IOL according to cataract guideline correcting the ametropia | Other | Cataract guideline |
Primary outcome
Aniseikonia
Time frame: 1 year
Measure amount of aniseikonia by measuring aniseikonia with both computer program aniseikonia inspector and the New Aniseikonia test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: No. No planing on sharing
Related trials for 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
Not yet recruiting
Macular Resurfacing Using Autologous ILM Patch Transposition for Idiopathic Epiretinal Membrane
Idiopathic Epiretinal Membrane
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract guideline in people with Epiretinal Membrane, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 2 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 7 Sep 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 Denmark. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aniseikonia (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 7 Sep 2018; AzTrials last refreshed its copy on 3 Nov 2026.