Trial Outcomes & Findings for Observational Study of Ocular Inflammation in Patients Undergoing a Pars Plana Vitrectomy (NCT NCT01319318)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

Week 4

Results posted on

2013-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Pars Plana Vitrectomy Pars plana vitrectomy performed in study eye on Day 0.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pars Plana Vitrectomy n=25 Participants Pars plana vitrectomy performed in study eye on Day 0.
Age Continuous	69.6 Years STANDARD_DEVIATION 10.06 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Intent to treat population included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Pars Plana Vitrectomy n=25 Participants Pars plana vitrectomy performed in study eye on Day 0.
Percentage of Participants With Vitreous Cell Count of 0	88.0 Percentage of participants

Adverse Events

Pars Plana Vitrectomy

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pars Plana Vitrectomy n=25 participants at risk Pars plana vitrectomy performed in study eye on Day 0.
Infections and infestations Pneumonia	4.0% 1/25

Other adverse events

Other adverse events
Measure	Pars Plana Vitrectomy n=25 participants at risk Pars plana vitrectomy performed in study eye on Day 0.
Eye disorders Ocular pain	36.0% 9/25
Eye disorders Eye redness	8.0% 2/25

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER