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

This study is currently recruiting participants.
Verified October 2012 by Yeungnam University College of Medicine
Sponsor:
Information provided by (Responsible Party):
Min Sagong, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier:
NCT01630876
First received: June 26, 2012
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention
Epiretinal Membrane
 Procedure: Vitrectomy only group
Procedure: Combined therapy group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anatomic and Functional Outcomes of 23-gauge Vitrectomy Combined With Posterior Subtenon Triamcinolone Injection for the Treatment of Idiopathic Epiretinal Membrane

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yeungnam University College of Medicine:

Primary Outcome Measures:
  • Changes of best corrected visual acuity and central retinal thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Changes in status of ISOS line [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Changes in status of ISOS line on optical coherence tomography (OCT) at baseline and 1, 3, 6 months after injection


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630876

Locations
Korea, Republic of
Yeungnam University College of Medicine Recruiting
Daegu, Korea, Republic of, 705-717
Contact: Min Sagong     82-53-620-4191     msagong@ynu.ac.kr    
Principal Investigator: Min Sagong            
Sponsors and Collaborators
Yeungnam University College of Medicine
  More Information

No publications provided

Responsible Party: Min Sagong, Assistant Professor, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT01630876     History of Changes
Other Study ID Numbers: YUH-12-0309-M2
Study First Received: June 26, 2012
Last Updated: October 1, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Yeungnam University College of Medicine:
Epiretinal membrane
triamcinolone acetonide

Additional relevant MeSH terms:
Epiretinal Membrane
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013