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

Macular Edema Clinical Trial

Official title:

Ozurdex as an Treatment Option for Macula Edema Due to Irvine Gass Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945892
• Other study ID #: MAF/ISS/OPH/RET/011
• Status: Completed
• Phase: N/A
• First received: September 16, 2013
• Last updated: September 18, 2013
• Start date: November 2011
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Visual Acuity

Intervention

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".

Locations

Country	Name	City	State
Germany	Dept. of Ophthalmology, LMU Munich	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Allergan

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Best corrected visual acuity and visual acuity gain after 6 and 12 months.	12 months	No
Secondary	Retinal Thickness	Retinal thickness measured by OCT.	12 months	No
Secondary	Intraocular pressure	Intraocular pressure using Goldmann applanation tonometer	12 months	Yes