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

Primary Purpose

Epiretinal Membrane

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vitrectomy only group
Combined therapy group
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiretinal Membrane focused on measuring Epiretinal membrane, triamcinolone acetonide

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Yeungnam University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Vitrectomy only group

Combined therapy group

Arm Description

The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only.

The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy with concomitant posterior subtenon Triamcinolone acetate injection.

Outcomes

Primary Outcome Measures

Changes of best corrected visual acuity and central retinal thickness
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
Changes in status of ISOS line on optical coherence tomography (OCT) at baseline and 1, 3, 6 months after injection

Full Information

First Posted
June 26, 2012
Last Updated
October 1, 2012
Sponsor
Yeungnam University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01630876
Brief Title
Outcomes of Vitrectomy Combined With Subtenon Triamcinolone Injection for the Idiopathic Epiretinal Membrane
Official Title
Anatomic and Functional Outcomes of 23-gauge Vitrectomy Combined With Posterior Subtenon Triamcinolone Injection for the Treatment of Idiopathic Epiretinal Membrane
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
Keywords
Epiretinal membrane, triamcinolone acetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitrectomy only group
Arm Type
Sham Comparator
Arm Description
The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only.
Arm Title
Combined therapy group
Arm Type
Experimental
Arm Description
The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy with concomitant posterior subtenon Triamcinolone acetate injection.
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy only group
Intervention Description
The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only. The procedure will be done under retrobulbar anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Combined therapy group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of best corrected visual acuity and central retinal thickness
Description
Changes of best corrected visual acuity and central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 months after injection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in status of ISOS line
Description
Changes in status of ISOS line on optical coherence tomography (OCT) at baseline and 1, 3, 6 months after injection
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Yeungnam University College of Medicine
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Sagong
Phone
82-53-620-4191
Email
msagong@ynu.ac.kr
First Name & Middle Initial & Last Name & Degree
Min Sagong

12. IPD Sharing Statement

Learn more about this trial

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

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