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Clinical Trial Summary

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


Clinical Trial 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) ;


Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01945892
Study type Observational
Source Ludwig-Maximilians - University of Munich
Contact
Status Completed
Phase N/A
Start date November 2011
Completion date July 2013

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