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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozurdex | Drug | - 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". |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Best corrected visual acuity and visual acuity gain after 6 and 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Thickness | Retinal thickness measured by OCT. | 12 months |
| Intraocular pressure | Intraocular pressure using Goldmann applanation tonometer |
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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.
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Patients older than 18 years.
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang J Mayer, MD | LMU Munich | Principal Investigator |
| Christos Haritoglou, MD, PhD | LMU Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Ophthalmology, LMU Munich | Munich | 80336 | Germany |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
| 12 months |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |