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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2012

Interventions

  • Procedure: Pars Plana Vitrectomy
    • Pars plana vitrectomy performed in study eye on Day 0.

Arms, Groups and Cohorts

  • Pars Plana Vitrectomy
    • Pars plana vitrectomy performed in study eye on Day 0.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allergan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Allergan

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