Dexamethasone-Implant for the Treatment of Macula Edema Due to Irvine Gass Syndrome
Study Details
Study Description
Brief Summary
To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.
Condition or Disease | Intervention/Treatment | Phase |
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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:
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BCVA
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Patients suffering from diabetes mellitus should be evaluated also separately.
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Change in central retinal thickness using optical coherence tomography (OCT)
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Secondary parameters (elevated IOP, retinal detachments, vitreous hemorrhage, endophthalmitis rates)
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Irvine Gass Syndrome 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
- 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".
Other Names:
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Outcome Measures
Primary Outcome Measures
- Visual acuity [12 months]
Best corrected visual acuity and visual acuity gain after 6 and 12 months.
Secondary Outcome Measures
- Retinal Thickness [12 months]
Retinal thickness measured by OCT.
- Intraocular pressure [12 months]
Intraocular pressure using Goldmann applanation tonometer
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Dept. of Ophthalmology, LMU Munich | Munich | Germany | 80336 |
Sponsors and Collaborators
- Ludwig-Maximilians - University of Munich
- Allergan
Investigators
- Principal Investigator: Wolfgang J Mayer, MD, LMU Munich
- Principal Investigator: Christos Haritoglou, MD, PhD, LMU Munich
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MAF/ISS/OPH/RET/011