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

Seoul National University

Status: Unknown

Conditions: Retinal Disease; Epiretinal Membrane

Treatments: Procedure: Internal Limiting Membrane Peeling

Study type: Interventional

Funder types: Other

Identifiers

NCT04130841

1901-159-1006

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

135 participants in 3 patient groups

Spontaneous ILM peeling

Experimental group

Treatment:

Procedure: Internal Limiting Membrane Peeling

Active ILM peeling

Active Comparator group

Treatment:

Procedure: Internal Limiting Membrane Peeling

No ILM peeling

No Intervention group