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

NCT ID: NCT01630876

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Epiretinal Membrane

Keywords

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Epiretinal membrane triamcinolone acetonide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitrectomy only group

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

Group Type SHAM_COMPARATOR

Vitrectomy only group

Intervention Type PROCEDURE

The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only. The procedure will be done under retrobulbar anesthesia.

Combined therapy group

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

Group Type EXPERIMENTAL

Combined therapy group

Intervention Type PROCEDURE

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.

Interventions

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Vitrectomy only group

The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only. The procedure will be done under retrobulbar anesthesia.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeungnam University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Min Sagong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yeungnam University College of Medicine

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Min Sagong

Role: primary

Other Identifiers

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YUH-12-0309-M2

Identifier Type: -

Identifier Source: org_study_id