NCT01299129

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 29, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

February 17, 2011

Last Update Submit

December 24, 2011

Conditions

Uveitis Related Cystoid Macular Edema

Keywords

UveitisCystoid macular edemamicroperimetryfunctional visual acuityintravitreal triamcinolone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

uveitis ambulance patients of the department of ophthalmology, medical university vienna

You may qualify if:

  • intraocular inflammation
  • able to read
  • \> 18 years old

You may not qualify if:

  • cataract
  • amblyopia
  • dyslexia
  • already applicated intravitreal triamcinolone for current cystoid macular edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

UveitisMacular Edema

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesMacular DegenerationRetinal DegenerationRetinal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. univ

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 18, 2011

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 29, 2011

Record last verified: 2011-12

Locations

AU(1)