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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01504074
Other study ID # 071/2009
Secondary ID
Status Completed
Phase N/A
First received December 28, 2011
Last updated September 23, 2015
Start date November 2011

Study information

Verified date September 2015
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 100 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Department of Ophthalmology Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of central retinal thickness 3 months No
Secondary Increase of Best corrected visual acuity 3 months No