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

Anatomic and Functional Outcomes of 23-gauge Vitrectomy Combined With Posterior Subtenon Triamcinolone Injection for the Treatment of Idiopathic Epiretinal Membrane

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

Study Overview

• Status: Unknown
• Conditions: Epiretinal Membrane
• Intervention / Treatment: Procedure: Vitrectomy only group; Procedure: Combined therapy group

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 705-717
    • Recruiting
    • Yeungnam University College of Medicine
    • Contact: Min Sagong; Phone Number: 82-53-620-4191; Email: msagong@ynu.ac.kr
    • Principal Investigator: Min Sagong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Vitrectomy only group; The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only.	Procedure: Vitrectomy only group; The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only. The procedure will be done under retrobulbar anesthesia.
Experimental: Combined therapy group; The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy with concomitant posterior subtenon Triamcinolone acetate injection.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yeungnam University College of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): October 3, 2012
• Last Update Submitted That Met QC Criteria: October 1, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: triamcinolone acetonide; Epiretinal membrane
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Epiretinal Membrane
• Other Study ID Numbers: YUH-12-0309-M2