Epiretinal MembraneNCT01985490
Change in Foveal Avascular Zone After Removal of Epiretinal Membrane and Internal Limiting Membrane
A study testing epiretinal membrane and internal limiting membrane removal in people with Epiretinal Membrane, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Fovea is characterized by its vessel-free zone, called foveal avascular zone and it can be visualized by fluorescein angiography. Removal of epiretinal membrane and internal limiting membrane is frequently performed procedure and we suspected that these procedures may affect integrity of foveal avascular zone. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- epiretinal membrane and internal limiting membrane removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to May 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- epiretinal membrane
Who cannot join
- history of vitrectomy, intraocular surgery
- any macular disease other than epiretinal membrane
- media opacity obscuring the image of fluorescein angiography
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul
Se Woong Kang, MD, 82-2-3410-3562, swkang@skku.edu
Se Woong Kang, MD
About this study
Fovea is characterized by its vessel-free zone, called foveal avascular zone and it can be visualized by fluorescein angiography. Removal of epiretinal membrane and internal limiting membrane is frequently performed procedure and we suspected that these procedures may affect integrity of foveal avascular zone.
The purpose of the present study is to evaluate the change of foveal avascular zone after removal of epiretinal membrane and internal limiting membrane
- Conditions
- Epiretinal Membrane
- Being tested
- epiretinal membrane and internal limiting membrane removal
- Keywords
- epiretinal membrane, foveal avascular zone, internal limiting membrane
- 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 and internal limiting membrane removalProcedure or surgery
fluorescein angiography is performed before, 1 week, 3months and 6months after the epiretinal membrane and internal limiting membrane removal.
| Study group | Role | What they receive |
|---|---|---|
| epiretinal membrane | Experimental | Not described Receives: Procedure: epiretinal membrane and internal limiting membrane removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
area of foveal avascular zone
the change in area of foveal avascular zone at postoperative 6 months
Measured: postoperative 6 months
Secondary outcomes (3)
change in visual acuity
Measured: postoperative 6 months
change in macular thickness
Measured: at 6 months
change in metamorphopsia
Measured: postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014 (estimated)
- Study completionMay 2015 (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.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Se Woong Kang, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985490
- Sponsor's protocol ID
- 2013-07-163
- Status last verified
- Nov 2013
- First submitted
- 10 Nov 2013
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Foveal Avascular Zone After Removal of Epiretinal Membrane and Internal Limiting Membrane
- ClinicalTrials.gov ID
- NCT01985490
- Acronym / sponsor ID
- 2013-07-163
- Conditions
- Epiretinal Membrane
- Keywords
- epiretinal membrane, foveal avascular zone, internal limiting membrane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 15 Nov 2013 (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.
Fovea is characterized by its vessel-free zone, called foveal avascular zone and it can be visualized by fluorescein angiography. Removal of epiretinal membrane and internal limiting membrane is frequently performed procedure and we suspected that these procedures may affect integrity of foveal avascular zone.
The purpose of the present study is to evaluate the change of foveal avascular zone after removal of epiretinal membrane and internal limiting membrane
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epiretinal membrane | Experimental | Procedure: epiretinal membrane and internal limiting membrane removal |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- epiretinal membrane
Key exclusion criteria (3 listed)
- history of vitrectomy, intraocular surgery
- any macular disease other than epiretinal membrane
- media opacity obscuring the image of fluorescein angiography
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 and internal limiting membrane removalfluorescein angiography is performed before, 1 week, 3months and 6months after the epiretinal membrane and internal limiting membrane removal. | Procedure or surgery | epiretinal membrane |
Primary outcome
area of foveal avascular zone
Time frame: postoperative 6 months
the change in area of foveal avascular zone at postoperative 6 months
3 secondary outcomes
change in visual acuity
Time frame: postoperative 6 months
change in macular thickness
Time frame: at 6 months
change in metamorphopsia
Time frame: postoperative 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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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.
Se Woong Kang, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epiretinal membrane and internal limiting membrane removal in people with Epiretinal Membrane, run by Samsung Medical Center at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 26 Nov 2013. 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 South Korea. 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 Se Woong Kang, MD (82-2-3410-3562, swkang@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area of foveal avascular zone (time frame: postoperative 6 months). 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 26 Nov 2013.