Morphological and Functional Evaluation of Irvine-Gass Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Marion Munk, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01504074
First received: December 28, 2011
Last updated: January 4, 2012
Last verified: December 2011
  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 ]

Estimated Enrollment: 30
Study Start Date: November 2011
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 and older
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

Contacts
Contact: Marion Munk, Dr.med. univ 00431404003834 marion.munk@meduniwien.ac.at
Contact: Christopher Kiss 00431404004847 christopher.kiss@meduniwien.ac.at

Locations
Austria
Department of Ophthalmology Medical University of Vienna Recruiting
Vienna, Austria, 1190
Contact: Jasmin Mittermüller    00431404004847      
Principal Investigator: Marion Munk, Dr. med. univ         
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

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: January 4, 2012
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:
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Tetrahydrozoline
Ophthalmic Solutions
Levobunolol
Bunolol
Ketorolac Tromethamine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014