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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01319318
Recruitment Status : Completed
First Posted : March 21, 2011
Results First Posted : July 2, 2013
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment
Vitrectomy Procedure: Pars Plana Vitrectomy

Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012
Groups and Cohorts
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Group/Cohort Intervention/treatment
Pars Plana Vitrectomy
Pars plana vitrectomy performed in study eye on Day 0.
 Procedure: Pars Plana Vitrectomy
Pars plana vitrectomy performed in study eye on Day 0.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who plan on undergoing a pars plana vitrectomy
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319318


Locations
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United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01319318    
Other Study ID Numbers: GMA-OZU-10-017
First Posted: March 21, 2011    Key Record Dates
Results First Posted: July 2, 2013
Last Update Posted: July 2, 2013
Last Verified: April 2013