Outcomes of Vitrectomy Combined With Subtenon Triamcinolone Injection for the Idiopathic Epiretinal Membrane

Overview

This study compares the anatomical and visual outcomes of patients with idiopathic epiretinal membrane(ERM) treated by vitrectomy and membrane peeling with or without subtenon triamcinolone acetonide injection

Full Title of Study: “Anatomic and Functional Outcomes of 23-gauge Vitrectomy Combined With Posterior Subtenon Triamcinolone Injection for the Treatment of Idiopathic Epiretinal Membrane”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2013

Interventions

  • Procedure: Vitrectomy only group
    • The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only. The procedure will be done under retrobulbar anesthesia.
  • Procedure: Combined therapy group
    • The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy with concomitant posterior subtenon Triamcinolone acetate injection. For the posterior subtenon Triamcinolone acetate injection injection, a 1 ml of a 40 mg/ml of triamcinolone acetonide was given in the inferotemporal quadrant using a 27-gauge needle on 3-ml syringe. The conjunctiva and the Tenon’s capsule were penetrated with the bevel of the needle toward the globe. The needle was advanced toward the macular area, taking care to remain in contact with the globe until the hub was firmly pressed against the conjunctival fornix and then the corticosteroid was slowly injected.

Arms, Groups and Cohorts

  • Sham Comparator: Vitrectomy only group
    • The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only.
  • Experimental: Combined therapy group
    • The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy with concomitant posterior subtenon Triamcinolone acetate injection.

Clinical Trial Outcome Measures

Primary Measures

  • Changes of best corrected visual acuity and central retinal thickness
    • Time Frame: 6 months
    • Changes of best corrected visual acuity and central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 months after injection

Secondary Measures

  • Changes in status of ISOS line
    • Time Frame: 6 months
    • Changes in status of ISOS line on optical coherence tomography (OCT) at baseline and 1, 3, 6 months after injection

Participating in This Clinical Trial

Inclusion Criteria

  • 1.The participant must have idiopathic epiretinal membrane 2.The participant must be willing and able to comply with the protocol. Exclusion Criteria:

  • 1. The participant has idiopathic epiretinal membrane with other ocular vascular diseases such as Diabetes retinopathy, BRVO, etc. 2. The participant has any additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy. 3. The participant has had intraocular surgery (including lens replacement surgery). 4. The participant has a history of (within the last six months), or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yeungnam University College of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Min Sagong, Assistant Professor – Yeungnam University College of Medicine

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