Dexamethasone-Implant for the Treatment of Macula Edema Due to Irvine Gass Syndrome

Completed

• Conditions: Macular Edema; Visual Acuity
• Interventions: Drug: Ozurdex

• Registration Number: NCT01945892
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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 Timeline

• Study Start: 2011-11
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2013-09
• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-18
• Last Update Submitted: 2013-09-18
• Study First Posted: 2013-09-19
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Irvine Gass Syndrome	Ozurdex	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.

Primary Outcome Measures

Name	Time	Method
Visual acuity	12 months	Best corrected visual acuity and visual acuity gain after 6 and 12 months.

Secondary Outcome Measures

Name	Time	Method
Retinal Thickness	12 months	Retinal thickness measured by OCT.
Intraocular pressure	12 months	Intraocular pressure using Goldmann applanation tonometer

Trial Locations

Locations (1)

Dept. of Ophthalmology, LMU Munich; 🇩🇪 Munich, Germany