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

Sponsor
Ludwig-Maximilians - University of Munich (Other)
Overall Status
Completed
CT.gov ID
NCT01945892
Collaborator
Allergan (Industry)
23
1
20
1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
23 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Ozurdex as an Treatment Option for Macula Edema Due to Irvine Gass Syndrome
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [12 months]

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

    Secondary Outcome Measures

    1. Retinal Thickness [12 months]

      Retinal thickness measured by OCT.

    2. Intraocular pressure [12 months]

      Intraocular pressure using Goldmann applanation tonometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Ophthalmology, LMU Munich Munich Germany 80336

    Sponsors and Collaborators

    • Ludwig-Maximilians - University of Munich
    • Allergan

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wolfgang Mayer, Dr., Ludwig-Maximilians - University of Munich
    ClinicalTrials.gov Identifier:
    NCT01945892
    Other Study ID Numbers:
    • MAF/ISS/OPH/RET/011
    First Posted:
    Sep 19, 2013
    Last Update Posted:
    Sep 19, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by Wolfgang Mayer, Dr., Ludwig-Maximilians - University of Munich
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 19, 2013