Observational Study of Ocular Inflammation in Patients Undergoing a Pars Plana Vitrectomy

Completed

• Conditions: Vitrectomy
• Interventions: Procedure: Pars Plana Vitrectomy

• Registration Number: NCT01319318
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the degree of post-operative ocular inflammation in patients who are undergoing a pars plana vitrectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-04
• Results First Submitted: 2013-04-15
• Results First Submitted QC: 2013-04-15
• Last Update Submitted: 2013-04-15
• Results First Posted: 2013-07-02
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pars Plana Vitrectomy	Pars Plana Vitrectomy	Pars plana vitrectomy performed in study eye on Day 0.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Vitreous Cell Count of 0	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.