Irvine Gass SyndromeNCT01504074
Morphological and Functional Evaluation of Irvine-Gass Syndrome
An observational study of Irvine Gass Syndrome, run by Medical University of Vienna at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Irvine Gass Syndrome
- What is being tested?
- if needed (decided individually) either Acular eye drops, Ultracortenol eye drop or intravitreal triamcinolone injection
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2011to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients suffering on CME secondary to cataract surgery
Who may be able to join
- > 18 years
- St.p Cataract surgery
- able to read
- informed consent
- with fluorescein angiography and SD-OCT diagnosed Irvine Gass syndrome
Who cannot join
- < 18 years
- CME of other origin
- diabetic macular edema
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Ophthalmology Medical University of Vienna
Vienna, State of Vienna, 1190
About this study
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
- Conditions
- Irvine Gass Syndrome
- Being tested
- if needed (decided individually) either Acular eye drops, Ultracortenol eye drop or intravitreal triamcinolone injection
- Keywords
- Irvine Gass syndrome, multimodal imaging, SD-OCT, CME secondary to cataract surgery, in vivo correlation of morphology and function
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
if needed (decided individually) either Acular eye drops, Ultracortenol eye drop or intravitreal triamcinolone injectionBehavioural
if prescribed: Ultracortenol/ Acular eye drops 3-4 times a day, if prescribed: singular intravitreal triamcinolone injection
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering on CME secondary to cataract surgery | Not described Receives: Behavioral: if needed (decided individually) either Acular eye drops, Ultracortenol eye drop or intravitreal triamcinolone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of central retinal thickness
Measured: 3 months
Secondary outcomes (1)
Increase of Best corrected visual acuity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irvine Gass SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marion Munk, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504074
- Sponsor's protocol ID
- 071/2009
- Status last verified
- Sep 2015
- First submitted
- 28 Dec 2011
- Last updated
- 24 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Functional Evaluation of Irvine-Gass Syndrome
- ClinicalTrials.gov ID
- NCT01504074
- Acronym / sponsor ID
- 071/2009
- Conditions
- Irvine Gass Syndrome
- Keywords
- Irvine Gass syndrome, multimodal imaging, SD-OCT, CME secondary to cataract surgery, in vivo correlation of morphology and function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2014 (actual)
- First posted
- 5 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering on CME secondary to cataract surgery | – | Behavioral: if needed (decided individually) either Acular eye drops, Ultracortenol eye drop or intravitreal triamcinolone injection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients suffering on CME secondary to cataract surgery
Key inclusion criteria (5 listed)
- > 18 years
- St.p Cataract surgery
- able to read
- informed consent
- with fluorescein angiography and SD-OCT diagnosed Irvine Gass syndrome
Key exclusion criteria (3 listed)
- < 18 years
- CME of other origin
- diabetic macular edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| if needed (decided individually) either Acular eye drops, Ultracortenol eye drop or intravitreal triamcinolone injectionif prescribed: Ultracortenol/ Acular eye drops 3-4 times a day, if prescribed: singular intravitreal triamcinolone injection | Behavioural | Patients suffering on CME secondary to cataract surgery |
Primary outcome
Reduction of central retinal thickness
Time frame: 3 months
1 secondary outcome
Increase of Best corrected visual acuity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
Related trials for Irvine Gass Syndrome
Active, not recruitingPhase 2
Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irvine Gass Syndrome, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of central retinal thickness (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.