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OpenTrials
Completed

NCT Number: NCT01945892

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

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Ophthalmology, LMU Munich

Munich, 80336, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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".

Other names: Dexamethasone-implant

Primary outcomes

  1. Visual acuity

    Time frame: 12 months

    Best corrected visual acuity and visual acuity gain after 6 and 12 months.

Secondary outcomes

  1. Retinal Thickness

    Time frame: 12 months

    Retinal thickness measured by OCT.

  2. Intraocular pressure

    Time frame: 12 months

    Intraocular pressure using Goldmann applanation tonometer

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 19, 2013
Registry last updated
Sep 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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