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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01319318
First received: March 18, 2011
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention
Vitrectomy
 Procedure: Pars Plana Vitrectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients with Vitreous Cell Count of 0 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319318

Locations
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01319318     History of Changes
Other Study ID Numbers: GMA-OZU-10-017
Study First Received: March 18, 2011
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Temazepam
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 16, 2013