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

Arm | Intervention/treatment |
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Sham Comparator: Vitrectomy only group
The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only.
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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.
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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. |
- 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
- 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

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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 |
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:
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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).

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
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 |
Responsible Party: | Min Sagong, Assistant Professor, Yeungnam University College of Medicine |
ClinicalTrials.gov Identifier: | NCT01630876 |
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 |
Epiretinal membrane triamcinolone acetonide |
Epiretinal Membrane Retinal Diseases Eye Diseases |