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

NCT ID: NCT01945892

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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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)

Conditions

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Macular Edema Visual Acuity

Keywords

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macular edema, irvine gass syndrome, ozurdex

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ozurdex

Intervention Type 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".

Interventions

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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".

Intervention Type DRUG

Other Intervention Names

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Dexamethasone-implant

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Wolfgang Mayer

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wolfgang J Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

LMU Munich

Christos Haritoglou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

LMU Munich

Locations

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Dept. of Ophthalmology, LMU Munich

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MAF/ISS/OPH/RET/011

Identifier Type: -

Identifier Source: org_study_id