Epiretinal Membrane, Macular Edema
Conditions
Keywords
Epiretinal Membrane, Macular Edema, Dexamethasone Intravitreal Implant (Ozurdex), Pars Plana Vitrectomy
Brief summary
The purpose of this study is to evaluate the effect of dexamethasone intravitreal implant (Ozurdex) in combination with pars plana vitrectomy and membrane peeling for idiopathic epiretinal membrane (ERM).
Detailed description
Pars plana vitrectomy with membrane peeling has been used for years to successfully to treat ERM (epiretinal membrane). However, despite successful surgery, approximately 10-30% of patients may not experience any improvement in visual acuity (ref. 1-7). Macular causes of unsatisfactory visual outcome following vitrectomy include persistent macular edema and reoccurrence of epiretinal membrane (ref. 1-7). Concomitant administration of intravitreal corticosteroids (triamcinolone acetonide) after pars plana vitrectomy and membrane peeling for epiretinal membrane has been reported to speed up and improve the anatomic and functional outcome (ref 8). Given that intravitreal triamcinolone has been reported to last approximately 113 days ina post-vitrectomy eye (ref. 9); the investigators postulate that a longer-acting corticosteroid such as Ozurdex could not only have the benefits of improved anatomic and functional outcomes, but also a longer sustained effect.
Interventions
DRUGDexamethasone Intravitreal Implant
Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.
Sponsors
Barnes Retina Institute
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with idiopathic epiretinal membrane * Preoperative visual acuity of snellen equivalent 20/32 or worse
Exclusion criteria
* History or presence of any of the following: * uveitis * macular hole * previous vitreoretinal surgery * any other retinal pathology that could affect anatomic or functional results * Age Related Macular Degeneration * Diabetic Retinopathy * Diabetic Macular Edema * Retinal Vein Occlusion * Pre-existing Macular Disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in best corrected visual acuity | 6 months | At all study visits: ETDRS visual acuity will be measured visit excluding post op day 1 (snellen visual acuity will be measured). Intraocular pressure (IOP) will be checked. Spectral Domain Optical Coherence Tomography (OCT). Dilated fundus exam. At Pre Op, Post Op Week 4, 8, 12, 16, 20 and 24 visits: ETDRS visual acuity will be measured. IOP check. Spectral Domain OCT. Fundus photography. Fundus Autofluorescence (AF). Fluorescein Angiography (FA). Dilated Fundus exam. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups | 6 months | At all visits: ETDRS visual acuity will be measured except post op day 1 (snellen visual acuity will be measured) Intraocular pressure (IOP) will be checked Spectral Domain Optical Coherence Tomography (OCT) Dilated fundus exam At Pre Op, Post Op Week 4, 8, 12, 16, 20, and 24: ETDRS visual acuity will be measured IOP will be checked Spectral Domain OCT Fundus Photography Fundus Auto Fluorescence (AF) Fluorescein Angiography (FA) Dilated Fundus exam |
Countries
United States
Outcome results
None listed