Retinal DiseaseNCT04130841
Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery
A study testing Internal Limiting Membrane Peeling in people with Retinal Disease and Epiretinal Membrane, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The patients who are diagnosed with idiopathic epiretinal membrane and scheduled to undergo epiretinal membrane removal will be treated with conventional vitrectomy and the epiretinal membrane will be removed. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Retinal Disease, Epiretinal Membrane
- What is being tested?
- Internal Limiting Membrane Peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2019to 31 Dec 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or older than 19 years
- Patients diagnosed with idiopathic epiretinal membrane and scheduled to undergo the epiretinal membrane removal surgery
Who cannot join
- Accompanied with retinal vascular disease or intraocular inflammation
- Prior treatment with vitrectomy in the study eye
- History of glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
The patients who are diagnosed with idiopathic epiretinal membrane and scheduled to undergo epiretinal membrane removal will be treated with conventional vitrectomy and the epiretinal membrane will be removed. After removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ILM) peeled off with the epiretinal membrane. (Group 1: spontaneous ILM peeling) If it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active Internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (Group 2: Active ILM peeling, Group 3: no ILM peeling) The outcomes of the three groups will be compared.
- Conditions
- Retinal Disease, Epiretinal Membrane
- Being tested
- Internal Limiting Membrane Peeling
- Keywords
- Internal limiting membrane peeling
- Medical subject headings
- Retinal Diseases, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Limiting Membrane PeelingProcedure or surgery
After removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ILM) peeled off with the epiretinal membrane. (Group 1: spontaneous ILM peeling) If it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active Internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (Group 2: Active ILM peeling, Group 3: no ILM peeling) The outcomes of the three groups will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous ILM peeling | Experimental | Not described Receives: Procedure: Internal Limiting Membrane Peeling |
| Active ILM peeling | Active comparator | Not described Receives: Procedure: Internal Limiting Membrane Peeling |
| No ILM peeling | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epiretinal membrane recurrence
Recurrence of the epiretinal membrane after the surgery
Measured: 12 months after the surgery
Secondary outcomes (3)
Best-corrected visual acuity
Measured: 12 months after the surgery
M-chart
Measured: 12 months after the surgery
Aniseikonia
Measured: 12 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start30 Sep 2019
- Primary completion29 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Un Chul Park, Seoul National University Hospital
- Investigators
- Un Chul Park, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130841
- Sponsor's protocol ID
- 1901-159-1006
- Status last verified
- Sep 2021
- First submitted
- 16 Oct 2019
- Last updated
- 23 Sep 2021
- Results posted
- 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 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery
- ClinicalTrials.gov ID
- NCT04130841
- Acronym / sponsor ID
- 1901-159-1006
- Conditions
- Retinal Disease, Epiretinal Membrane
- Keywords
- Internal limiting membrane peeling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 29 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Oct 2019 (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.
The patients who are diagnosed with idiopathic epiretinal membrane and scheduled to undergo epiretinal membrane removal will be treated with conventional vitrectomy and the epiretinal membrane will be removed. After removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ILM) peeled off with the epiretinal membrane. (Group 1: spontaneous ILM peeling) If it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active Internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (Group 2: Active ILM peeling, Group 3: no ILM peeling) The outcomes of the three groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spontaneous ILM peeling | Experimental | Procedure: Internal Limiting Membrane Peeling |
| Active ILM peeling | Active comparator | Procedure: Internal Limiting Membrane Peeling |
| No ILM peeling | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age equal to or older than 19 years
- Patients diagnosed with idiopathic epiretinal membrane and scheduled to undergo the epiretinal membrane removal surgery
Key exclusion criteria (3 listed)
- Accompanied with retinal vascular disease or intraocular inflammation
- Prior treatment with vitrectomy in the study eye
- History of glaucoma
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 |
|---|---|---|
| Internal Limiting Membrane PeelingAfter removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ILM) peeled off with the epiretinal membrane. (Group 1: spontaneous ILM peeling) If it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active Internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (Group 2: Active ILM peeling, Group 3: no ILM peeling) The outcomes of the three groups will be compared. | Procedure or surgery | Active ILM peeling, Spontaneous ILM peeling |
Primary outcome
Epiretinal membrane recurrence
Time frame: 12 months after the surgery
Recurrence of the epiretinal membrane after the surgery
3 secondary outcomes
Best-corrected visual acuity
Time frame: 12 months after the surgery
M-chart
Time frame: 12 months after the surgery
Aniseikonia
Time frame: 12 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 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.
Un Chul Park principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Limiting Membrane Peeling in people with Retinal Disease and Epiretinal Membrane, run by Seoul National University Hospital 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 2 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 23 Sep 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 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?
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?
Epiretinal membrane recurrence (time frame: 12 months after the 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 23 Sep 2021.