Uveitis Related Cystoid Macular EdemaNCT01299129
Functional and Morphologic Aspects of Intravitreal Triamcinolone for Uveitis-associated Cystoid Macular Edema
An observational study of Uveitis Related Cystoid Macular Edema, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Purpose: To evaluate the effect of intravitreal triamcinolone acetonide (IVTA) on uveitis-associated cystoid macular edema (CME) using high resolution optical coherence tomography (SDOCT) in conjunction with thorough visual function testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis Related Cystoid Macular Edema
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2009to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: uveitis ambulance patients of the department of ophthalmology, medical university vienna
Who may be able to join
- intraocular inflammation
- able to read
- > 18 years old
Who cannot join
- cataract
- amblyopia
- dyslexia
- already applicated intravitreal triamcinolone for current cystoid macular edema
Trial locations and contacts
1 site in 1 country.
About this study
Purpose:
To evaluate the effect of intravitreal triamcinolone acetonide (IVTA) on uveitis-associated cystoid macular edema (CME) using high resolution optical coherence tomography (SDOCT) in conjunction with thorough visual function testing.
Read more
Methods:
28 patients with uveitis-associated CME were examined before intravitreal triamcinolone injection (IVTA) (v1) and at day 1 (v2), week 1 (v3) and month 1 (v4) after injection. Retinal anatomy was evaluated using Cirrus HD-OCT (Carl Zeiss Meditec). Visual function testing consisted of assessing ETDRS distance visual acuity (VA), reading acuity and reading speed using a standardized German-language test (Radner Reading charts), contrast sensitivity using Pelli-Robson Contrast Sensitivity charts and fundus-controlled microperimetry using the MP-1 Microperimeter (Nidek). Here we utilized a cartesian grid consisting of a central locus and three concentric box-shaped stimulation areas. The changes of retinal anatomy over time were compared to the respective outcome of visual function.
- Conditions
- Uveitis Related Cystoid Macular Edema
- Keywords
- Uveitis, Cystoid macular edema, microperimetry, functional visual acuity, intravitreal triamcinolone
- Medical subject headings
- Uveitis, Macular Edema
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis Related Cystoid Macular EdemaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT01299129
- Sponsor's protocol ID
- 070/2009
- Status last verified
- Dec 2011
- First submitted
- 17 Feb 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Morphologic Aspects of Intravitreal Triamcinolone for Uveitis-associated Cystoid Macular Edema
- ClinicalTrials.gov ID
- NCT01299129
- Acronym / sponsor ID
- 070/2009
- Conditions
- Uveitis Related Cystoid Macular Edema
- Keywords
- Uveitis, Cystoid macular edema, microperimetry, functional visual acuity, intravitreal triamcinolone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Feb 2011 (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 the effect of intravitreal triamcinolone acetonide (IVTA) on uveitis-associated cystoid macular edema (CME) using high resolution optical coherence tomography (SDOCT) in conjunction with thorough visual function testing.
Methods:
28 patients with uveitis-associated CME were examined before intravitreal triamcinolone injection (IVTA) (v1) and at day 1 (v2), week 1 (v3) and month 1 (v4) after injection. Retinal anatomy was evaluated using Cirrus HD-OCT (Carl Zeiss Meditec). Visual function testing consisted of assessing ETDRS distance visual acuity (VA), reading acuity and reading speed using a standardized German-language test (Radner Reading charts), contrast sensitivity using Pelli-Robson Contrast Sensitivity charts and fundus-controlled microperimetry using the MP-1 Microperimeter (Nidek). Here we utilized a cartesian grid consisting of a central locus and three concentric box-shaped stimulation areas. The changes of retinal anatomy over time were compared to the respective outcome of visual function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- uveitis ambulance patients of the department of ophthalmology, medical university vienna
Key inclusion criteria (3 listed)
- intraocular inflammation
- able to read
- > 18 years old
Key exclusion criteria (4 listed)
- cataract
- amblyopia
- dyslexia
- already applicated intravitreal triamcinolone for current cystoid 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.
Primary outcome
Not reported in the source record.
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 29 Dec 2011.
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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 Uveitis Related Cystoid Macular Edema, 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 3 inclusion and 4 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 29 Dec 2011. 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.
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 29 Dec 2011.