Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT01945892
Brief 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)
Study:
NCT01945892
Study Brief:
Protocol Section:
NCT01945892