NCT01319318

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 2, 2013

Completed
Last Updated

July 2, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

March 18, 2011

Results QC Date

April 15, 2013

Last Update Submit

April 15, 2013

Conditions

Vitrectomy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Vitreous Cell Count of 0

    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.

    Week 4

Study Arms (1)

Pars Plana Vitrectomy

Pars plana vitrectomy performed in study eye on Day 0.

Procedure: Pars Plana Vitrectomy

Interventions

Pars Plana VitrectomyPROCEDURE

Pars plana vitrectomy performed in study eye on Day 0.

Pars Plana Vitrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who plan on undergoing a pars plana vitrectomy

You may qualify if:

  • Require pars plana vitrectomy in at least 1 eye
  • Best corrected visual acuity in the study eye between 20/400 and 20/40

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Antonio, Texas, United States

Location

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2011

First Posted

March 21, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 2, 2013

Results First Posted

July 2, 2013

Record last verified: 2013-04

Locations

US(1)