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

Not Applicable

• Conditions: Epiretinal Membrane
• Interventions: Procedure: Vitrectomy only group; Procedure: Combined therapy group

• Registration Number: NCT01630876
• Lead Sponsor: Yeungnam University College of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-03
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitrectomy only group	Vitrectomy only group	The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only.
Combined therapy group	Combined therapy group	The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy with concomitant posterior subtenon Triamcinolone acetate injection.

Primary Outcome Measures

Name	Time	Method
Changes of best corrected visual acuity and central retinal thickness	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 Outcome Measures

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

Trial Locations

Locations (1)

Yeungnam University College of Medicine; 🇰🇷 Daegu, Korea, Republic of