Morphological and Functional Evaluation of Irvine-Gass Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marion Munk, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01504074
First received: December 28, 2011
Last updated: September 23, 2015
Last verified: September 2015
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Reduction of central retinal thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase of Best corrected visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2011
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 28, 2011
Last Updated: September 23, 2015
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by 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
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Ketorolac Tromethamine
Triamcinolone diacetate
Levobunolol
Bunolol
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

ClinicalTrials.gov processed this record on August 25, 2016