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

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ClinicalTrials.gov Identifier: NCT01630876
Recruitment Status : Unknown
Verified October 2012 by Min Sagong, Yeungnam University College of Medicine.
Recruitment status was:  Recruiting
First Posted : June 28, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
Min Sagong, Yeungnam University College of Medicine

Study Description
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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

Condition or disease Intervention/treatment Phase
Epiretinal Membrane Procedure: Vitrectomy only group Procedure: Combined therapy group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630876


Locations
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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
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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
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012

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

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