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Morphological and Functional Evaluation of Irvine-Gass Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01504074
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Purpose: To evaluate morphological and functional characteristics of Irvine Gass syndrome

Methods: 30 patients suffering on Cystoid macular edema (CME) secondary to Cataract surgery will be observed and evaluated by fluorescein-angiography, SD-OCT, reading performance, contrast sensitivity and microperimetry in a fixed time schedule


Condition or disease Intervention/treatment
Irvine Gass Syndrome Behavioral: if needed (decided individually) either Acular eye drops, Ultracortenol eye drop or intravitreal triamcinolone injection

Study Design

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2011
Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patients suffering on CME secondary to cataract surgery Behavioral: if needed (decided individually) either Acular eye drops, Ultracortenol eye drop or intravitreal triamcinolone injection
if prescribed: Ultracortenol/ Acular eye drops 3-4 times a day, if prescribed: singular intravitreal triamcinolone injection


Outcome Measures

Primary Outcome Measures :
  1. Reduction of central retinal thickness [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Increase of Best corrected visual acuity [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
30 patients suffering on CME secondary to cataract surgery
Criteria

Inclusion Criteria:

  • > 18 years
  • St.p Cataract surgery
  • able to read
  • informed consent
  • with fluorescein angiography and SD-OCT diagnosed Irvine Gass syndrome

Exclusion Criteria:

  • < 18 years
  • CME of other origin
  • diabetic macular edema
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504074


Locations
Austria
Department of Ophthalmology Medical University of Vienna
Vienna, Austria, 1190
Sponsors and Collaborators
Medical University of Vienna
More Information

Responsible Party: Marion Munk, MD, Principal Investigator, Department of Ophthalmology and Optometry,, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01504074     History of Changes
Other Study ID Numbers: 071/2009
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by Marion Munk, Medical University of Vienna:
Irvine Gass syndrome
multimodal imaging
SD-OCT
CME secondary to cataract surgery
in vivo correlation of morphology and function

Additional relevant MeSH terms:
Syndrome
Macular Edema
Disease
Pathologic Processes
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Levobunolol
Bunolol
Ketorolac Tromethamine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents