NCT01945892

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.

Detailed description

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)

Conditions

• Macular Edema
• Visual Acuity

Interventions

Type	Name	Description
DRUG	Ozurdex	\- 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".

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-06-01
• Completion: 2013-07-01
• First posted: 2013-09-19
• Last updated: 2013-09-19

Locations

1 site across 1 country: Germany