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

Vitrectomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319318
• Other study ID #: GMA-OZU-10-017
• Status: Completed
• Phase: N/A
• First received: March 18, 2011
• Last updated: April 15, 2013
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vitrectomy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No