Dexamethasone-Implant for the Treatment of Macula Edema Due to Irvine Gass Syndrome

Study Overview
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Brief Summary
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To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.

Detailed Description
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20 to 25 patients suffering from Irvine Gass Syndrom should be monitored for at least six months, controlled monthly. In all cases best corrected visual acuity, Spectralis-OCT (volume thickness scan), fundus photography (Optomap), intraocular pressure, slitlamp assessment and indirect ophthalmoscopy should be performed on every visit. Fluorescein angiography should be performed at baseline and after 3 and 6 months. Inclusion criteria: Patients older than 18 years who develop macula edema secondary to cataract surgery. - Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an on label indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of Uveitis posterior. Exclusion criteria: Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days. Outcome: BCVA Patients suffering from diabetes mellitus should be evaluated also separately. Change in central retinal thickness using optical coherence tomography (OCT) Secondary parameters (elevated IOP, retinal detachments, vitreous hemorrhage, endophthalmitis rates)

Official Title
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Ozurdex as an Treatment Option for Macula Edema Due to Irvine Gass Syndrome

Conditions
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Macular Edema, Visual Acuity

Intervention / Treatment
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* Drug: Ozurdex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years who develop macula edema secondary to cataract surgery Exclusion Criteria: Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Irvine Gass Syndrome<br>Patients older than 18 years who develop macula edema secondary to cataract surgery. Group may receive intravitreal Ozurdex medication in case of persistent macular edema. | Drug: Ozurdex<br>* - Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an on label indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of Uveitis posterior.<br>* Other names: Dexamethasone-implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Best corrected visual acuity and visual acuity gain after 6 and 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Thickness | Retinal thickness measured by OCT. | 12 months | 
| Intraocular pressure | Intraocular pressure using Goldmann applanation tonometer | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular edema, irvine gass syndrome, ozurdex