- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130841
Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery
September 22, 2021 updated by: Un Chul Park, Seoul National University Hospital
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
135
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age equal to or older than 19 years
- Patients diagnosed with idiopathic epiretinal membrane and scheduled to undergo the epiretinal membrane removal surgery
Exclusion Criteria:
- Accompanied with retinal vascular disease or intraocular inflammation
- Prior treatment with vitrectomy in the study eye
- History of glaucoma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Spontaneous ILM peeling
|
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.
|
ACTIVE_COMPARATOR: Active ILM peeling
|
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.
|
NO_INTERVENTION: No ILM peeling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epiretinal membrane recurrence
Time Frame: 12 months after the surgery
|
Recurrence of the epiretinal membrane after the surgery
|
12 months after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Best-corrected visual acuity
Time Frame: 12 months after the surgery
|
12 months after the surgery
|
M-chart
Time Frame: 12 months after the surgery
|
12 months after the surgery
|
Aniseikonia
Time Frame: 12 months after the surgery
|
12 months after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Un Chul Park, Associate Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 30, 2019
Primary Completion (ANTICIPATED)
September 29, 2021
Study Completion (ANTICIPATED)
December 31, 2021
Study Registration Dates
First Submitted
October 16, 2019
First Submitted That Met QC Criteria
October 16, 2019
First Posted (ACTUAL)
October 17, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 23, 2021
Last Update Submitted That Met QC Criteria
September 22, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1901-159-1006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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