VitrectomyNCT01319318
Observational Study of Ocular Inflammation in Patients Undergoing a Pars Plana Vitrectomy
An observational study of Vitrectomy, run by Allergan at 1 site in United States.
Trial summary
This study will evaluate the degree of post-operative ocular inflammation in patients who are undergoing a pars plana vitrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitrectomy
- What is being tested?
- Pars Plana Vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jun 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who plan on undergoing a pars plana vitrectomy
Who may be able to join
- Require pars plana vitrectomy in at least 1 eye
- Best corrected visual acuity in the study eye between 20/400 and 20/40
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the degree of post-operative ocular inflammation in patients who are undergoing a pars plana vitrectomy.
- Conditions
- Vitrectomy
- Being tested
- Pars Plana Vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars Plana VitrectomyProcedure or surgery
Pars plana vitrectomy performed in study eye on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Pars Plana Vitrectomy | Pars plana vitrectomy performed in study eye on Day 0. Receives: Procedure: Pars Plana Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VitrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319318
- Sponsor's protocol ID
- GMA-OZU-10-017
- Status last verified
- Apr 2013
- First submitted
- 18 Mar 2011
- Last updated
- 2 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Ocular Inflammation in Patients Undergoing a Pars Plana Vitrectomy
- ClinicalTrials.gov ID
- NCT01319318
- Acronym / sponsor ID
- GMA-OZU-10-017
- Conditions
- Vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Posted 2 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the degree of post-operative ocular inflammation in patients who are undergoing a pars plana vitrectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pars Plana Vitrectomy | – | Procedure: Pars Plana VitrectomyPars plana vitrectomy performed in study eye on Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who plan on undergoing a pars plana vitrectomy
Key inclusion criteria (2 listed)
- Require pars plana vitrectomy in at least 1 eye
- Best corrected visual acuity in the study eye between 20/400 and 20/40
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pars Plana VitrectomyPars plana vitrectomy performed in study eye on Day 0. | Procedure or surgery | Pars Plana Vitrectomy |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitrectomy, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Vitreous Cell Count of 0 (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.