San Antonio, Texas, United States
NCT Number: NCT01319318
Observational Study of Ocular Inflammation in Patients Undergoing a Pars Plana Vitrectomy
This study will evaluate the degree of post-operative ocular inflammation in patients who are undergoing a pars plana vitrectomy.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Require pars plana vitrectomy in at least 1 eye
- Best corrected visual acuity in the study eye between 20/400 and 20/40
Exclusion criteria
- Use of any NSAIDs (topical or systemic) within 14 days
- Use of topical or systemic steroids within 30 days
- Active eye infection in either eye
- Any eye surgery within 6 months
- Prior pars plana vitrectomy, YAG capsulotomy or uveitis
Treatment and study plan
pars plana vitrectomy
ProcedurePars plana vitrectomy performed in study eye on Day 0.
Primary outcomes
-
Percentage of Participants With Vitreous Cell Count of 0
Time frame: Week 4
The study eye was dilated and the investigator used an instrument to count the number of visible cells in the vitreous, the jelly-like fluid that fills the back of the eye, using the following scale: 0 (no cells) best, +1 (1-10 cells), +2 (11-30 cells), +3 (31-50 cells) and +4 (>50 cells) worst.
Sponsors and collaborators
Lead sponsor
Allergan
Industry
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Mar 21, 2011
- Registry last updated
- Jul 2, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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