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Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery

Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04130841
Enrollment
135
Registered
2019-10-17
Start date
2019-09-30
Completion date
2021-12-31
Last updated
2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiretinal Membrane, Retinal Disease

Keywords

Internal limiting membrane peeling

Brief 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. 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.

Interventions

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Epiretinal membrane recurrence12 months after the surgeryRecurrence of the epiretinal membrane after the surgery

Secondary

MeasureTime frame
Best-corrected visual acuity12 months after the surgery
M-chart12 months after the surgery
Aniseikonia12 months after the surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026