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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01945892
Enrollment
23
Registered
2013-09-19
Start date
2011-11-30
Completion date
2013-07-31
Last updated
2013-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema, Visual Acuity

Keywords

macular edema, irvine gass syndrome, ozurdex

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)

Interventions

\- 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.

Sponsors

Allergan
CollaboratorINDUSTRY
Ludwig-Maximilians - University of Munich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual acuity12 monthsBest corrected visual acuity and visual acuity gain after 6 and 12 months.

Secondary

MeasureTime frameDescription
Retinal Thickness12 monthsRetinal thickness measured by OCT.
Intraocular pressure12 monthsIntraocular pressure using Goldmann applanation tonometer

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026