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Clinical Trials/NCT01630876
NCT01630876UnknownNot Applicable

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

Yeungnam University College of Medicine2 sites in 1 country50 target enrollmentStarted: January 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
2
Primary Endpoint
Changes of best corrected visual acuity and central retinal thickness

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • The participant has idiopathic epiretinal membrane with other ocular vascular diseases such as Diabetes retinopathy, BRVO, etc.
  • 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.
  • The participant has had intraocular surgery (including lens replacement surgery).
  • 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).

Outcomes

Primary Outcomes

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 Outcomes

  • Changes in status of ISOS line(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Min Sagong

Assistant Professor

Yeungnam University College of Medicine

Study Sites (2)

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