- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01504074
Morphological and Functional Evaluation of Irvine-Gass Syndrome
September 23, 2015 updated by: Marion Munk, Medical University of Vienna
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
50
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
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Vienna, Austria, 1190
- Department of Ophthalmology Medical University of Vienna
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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 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
30 patients suffering on CME secondary to cataract surgery
Description
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
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: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients suffering on CME secondary to cataract surgery
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if prescribed: Ultracortenol/ Acular eye drops 3-4 times a day, if prescribed: singular intravitreal triamcinolone injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of central retinal thickness
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase of Best corrected visual acuity
Time Frame: 3 months
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 1, 2014
Study Registration Dates
First Submitted
December 28, 2011
First Submitted That Met QC Criteria
January 4, 2012
First Posted (Estimate)
January 5, 2012
Study Record Updates
Last Update Posted (Estimate)
September 24, 2015
Last Update Submitted That Met QC Criteria
September 23, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Eye Diseases
- Disease
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Syndrome
- Macular Edema
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Pharmaceutical Solutions
- Sympatholytics
- Ophthalmic Solutions
- Triamcinolone
- Levobunolol
Other Study ID Numbers
- 071/2009
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.
Clinical Trials on Irvine Gass Syndrome
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Tufts Medical CenterRegeneron PharmaceuticalsTerminatedIrvine-Gass SyndromeUnited States
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Line KesselCompletedIrvine-Gass Syndrome | Postoperative Cystoid Macular EdemaDenmark
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