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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intravitreal injections other than intravitreal steroids within the last 2 weeks
Diagnosed with presumed infectious endophthalmitis: patients presenting with vision loss and hypopyon
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6 and 12 months
Awards & highlights
EPIIC Trial Summary
This trial is studying two different procedures to see which is better at treating endophthalmitis, which is an infection in the eye that can cause vision loss.
Who is the study for?
This trial is for adults over 18 with vision loss and signs of eye infection (endophthalmitis) after recent non-steroid eye injections. They must have some light perception and not be better suited to one treatment over another, as judged by their doctor. Those with recent eye surgery, trauma, certain other surgeries or conditions affecting vision aren't eligible.Check my eligibility
What is being tested?
The study aims to find out which treatment is better for an eye infection called endophthalmitis after intravitreal injections: Tap and Inject (TAI), where fluid is removed from the eye and medication injected, or Pars Plana Vitrectomy (PPV), a more invasive surgery that also includes antibiotics.See study design
What are the potential side effects?
Possible side effects include discomfort at the injection site, increased intraocular pressure, bleeding inside the eye for TAI; PPV may cause similar issues plus risks associated with more extensive surgery like cataract formation or retinal detachment.
EPIIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had eye injections, except for steroids, in the last 2 weeks.
Select...
I have vision loss and eye inflammation due to an infection.
EPIIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual acuity outcomes
Secondary outcome measures
Aqueous humor and vitreous sample Culture
Aqueous humor and vitreous sample Gram stain
Aqueous humor and vitreous sample Sensitivities
+10 moreEPIIC Trial Design
2Treatment groups
Active Control
Group I: Endophthalmitis Post Intravitreal Injections - PPVActive Control1 Intervention
Patients 18 years and older with presumed infectious endophthalmitis after non-steroid intravitreal injections randomized to PPV
Group II: Endophthalmitis Post Intravitreal Injections - TAIActive Control1 Intervention
Patients 18 years and older with presumed infectious endophthalmitis after non-steroid intravitreal injections randomized to TAI
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Who is running the clinical trial?
Rajeev MuniLead Sponsor
Unity Health TorontoLead Sponsor
539 Previous Clinical Trials
447,455 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had eye surgery for a retina problem.I haven't had eye injections, except for steroids, in the last 2 weeks.I have had surgery for glaucoma in my study eye.I have vision loss and eye inflammation due to an infection.I am 18 years old or older.My vision issues are only due to my retinal condition, not other eye problems.I had eye surgery on my study eye within the last 3 months.I have had a previous eye injury that broke the surface.
Research Study Groups:
This trial has the following groups:- Group 1: Endophthalmitis Post Intravitreal Injections - PPV
- Group 2: Endophthalmitis Post Intravitreal Injections - TAI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this trial for new participants?
"Affirmative. Per information sourced from clinicaltrials.gov, this research investigation is actively recruiting participants and was initially published on March 1st 2020 with the latest update coming April 26th 2021. This trial requires 310 individuals across one site to complete it successfully."
Answered by AI
How many subjects are currently engaging in this clinical investigation?
"Yes, the information available on clinicaltrials.gov confirms that this medical investigation is actively seeking participants. It was initially posted on March 1st 2020 and most recently amended on April 26th 2021. Currently, 310 patients are required from a single centre to complete the trial."
Answered by AI
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