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OpenTrials
Completed

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Antonio, Texas, United States

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

Procedure

Pars plana vitrectomy performed in study eye on Day 0.

Primary outcomes

  1. 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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