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

September 18, 2013 updated by: Wolfgang Mayer, Ludwig-Maximilians - University of Munich

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80336
        • Dept. of Ophthalmology, LMU Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients older than 18 years.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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".
Other Names:
  • Dexamethasone-implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 12 months
Best corrected visual acuity and visual acuity gain after 6 and 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal Thickness
Time Frame: 12 months
Retinal thickness measured by OCT.
12 months
Intraocular pressure
Time Frame: 12 months
Intraocular pressure using Goldmann applanation tonometer
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Allergan

Investigators

  • Principal Investigator: Wolfgang J Mayer, MD, LMU Munich
  • Principal Investigator: Christos Haritoglou, MD, PhD, LMU Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 16, 2013

First Submitted That Met QC Criteria

September 18, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

September 19, 2013

Last Update Submitted That Met QC Criteria

September 18, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAF/ISS/OPH/RET/011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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