EndophthalmitisNCT03420820
Concentrating on Antisepsis: 5% vs. 10% Povidone-Iodine Prior to Intravitreal Injection
A study testing Bacterial Culture Swab in people with Endophthalmitis and Eye Infections, run by Matthew Bolton.
Trial summary
This is a randomized controlled single blind prospective study evaluating the efficacy of ocular surface sterilization between three different povidone-iodine preparation techniques prior to intravitreal injection. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Endophthalmitis, Eye Infections
- What is being tested?
- Bacterial Culture Swab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- enrollment will be open to men and women of all ethnic backgrounds between the ages of 18-100 who are offered intravitreal injections by Dr. Anthony Mazzulla at his Retina clinic at the Ochsner Clinic Foundation as a treatment for diabetic macular edema, proliferative diabetic retinopathy, age related exudative macular degeneration, or any other cause of choroidal neovascularization or cystoid macular edema.
Who cannot join
- Current eye infection, actively treated blepharitis, current use of topical or systemic antimicrobial agents, current use of topical or systemic corticosteroids, allergy to iodine, pregnancy, children.
Trial locations and contacts
No sites are listed yet.
About this study
This is a randomized controlled single blind prospective study evaluating the efficacy of ocular surface sterilization between three different povidone-iodine preparation techniques prior to intravitreal injection. The primary end point is significant different between median colony-forming units pre- and post-sterilization and injection.
Read the detailed description
Introduction: An estimated 5.9 - 7.9 million intravitreal injections (IVI) were given in 2016. While the incidence of post-injection endophthalmitis is exceedingly low, it is a feared complication of the procedure. 96% of culture-positive post-injection endophthalmitis cases are caused by conjunctival commensals, emphasizing the importance of ocular surface sterilization prior to IVI. The most recently published guidelines for IVI state that "Povidone-Iodine (5-10%) should be the last agent applied to the intended injection site before the injection," a recommendation that is universally followed. However, there is no standard of care regarding the concentration of PI nor the field of sterilization (e.g, cleaning the eyelids and lashes), and technique varies widely in clinical practice. The literature reveals no direct comparison of 5% vs 10% PI in the context of intravitreal injection.
Methods: Single-center randomized prospective trial enrolling patients into three protocols: 5% P-I applied to ocular surface from bottle, 10% P-I swabstick applied to ocular surface, and 10% P-I swabstick applied to lids, lashes, and ocular surface. Pre-procedure cultures will be obtained from the ocular surface, and a second culture will be taken following antisepsis, injection, and irrigation. Standard microbiologic techniques will be used to collect, culture, identify, and quantify ocular surface bacteria counts. Kruskal Wallis test will be used to assess significant difference between median bacterial loads at baseline and post-cleaning, as well as median reduction from baseline. Chi-squared test will be used to assess significant difference between reduction in number of patients with specific bacteria. Following injection, a patient survey will be administered to compare patients' subjective symptoms of ocular surface irritation during the PI preparation phase of the procedure.
Conclusions: The investigators anticipate that no significant difference exists in decrease of median CFUs between the three protocols, and that lower concentration of P-I provides a more comfortable patient experience.
- Conditions
- Endophthalmitis, Eye Infections
- Being tested
- Bacterial Culture Swab
- Keywords
- intravitreal injection, povidone-iodine, ocular surface flora, endophthalmitis, betadine
- Medical subject headings
- Endophthalmitis, Eye Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial Culture SwabBiological
Culture swabs will be obtained before application of PI and after injection.
| Study group | Role | What they receive |
|---|---|---|
| 5% Betadine, Ocular Surface only | Experimental | Use of 5% P-I from bottle dropper to sterilize the ocular surface only, prior to injection. Intervention: bacterial culture swab. Receives: Biological: Bacterial Culture Swab |
| 10% Betadine, Ocular Surface only | Experimental | Use of 10% P-I swabstick to sterilize the ocular surface only, prior to injection. Intervention: bacterial culture swab. Receives: Biological: Bacterial Culture Swab |
| 10% Betadine, Ocular Surface and Adnexa | Experimental | Use of 10% P-I swabstick to sterilize the ocular surface and surrounding lids and eyelashes only, prior to injection. Intervention: bacterial culture swab. Receives: Biological: Bacterial Culture Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Colony-Forming Units
Median CFUs compared pre- and post-injection
Measured: 3 months
Secondary outcomes (1)
Patient's ocular surface symptoms during sterilization with povidone-iodine
Survey-based
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndophthalmitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Bolton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Bolton, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Donald Mazzulla, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420820
- Sponsor's protocol ID
- 1162018
- Status last verified
- Jan 2018
- First submitted
- 16 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentrating on Antisepsis: 5% vs. 10% Povidone-Iodine Prior to Intravitreal Injection
- ClinicalTrials.gov ID
- NCT03420820
- Acronym / sponsor ID
- 1162018
- Conditions
- Endophthalmitis, Eye Infections
- Keywords
- intravitreal injection, povidone-iodine, ocular surface flora, endophthalmitis, betadine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Matthew BoltonUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled single blind prospective study evaluating the efficacy of ocular surface sterilization between three different povidone-iodine preparation techniques prior to intravitreal injection. The primary end point is significant different between median colony-forming units pre- and post-sterilization and injection.
Detailed description
Introduction: An estimated 5.9 - 7.9 million intravitreal injections (IVI) were given in 2016. While the incidence of post-injection endophthalmitis is exceedingly low, it is a feared complication of the procedure. 96% of culture-positive post-injection endophthalmitis cases are caused by conjunctival commensals, emphasizing the importance of ocular surface sterilization prior to IVI. The most recently published guidelines for IVI state that "Povidone-Iodine (5-10%) should be the last agent applied to the intended injection site before the injection," a recommendation that is universally followed. However, there is no standard of care regarding the concentration of PI nor the field of sterilization (e.g, cleaning the eyelids and lashes), and technique varies widely in clinical practice. The literature reveals no direct comparison of 5% vs 10% PI in the context of intravitreal injection.
Methods: Single-center randomized prospective trial enrolling patients into three protocols: 5% P-I applied to ocular surface from bottle, 10% P-I swabstick applied to ocular surface, and 10% P-I swabstick applied to lids, lashes, and ocular surface. Pre-procedure cultures will be obtained from the ocular surface, and a second culture will be taken following antisepsis, injection, and irrigation. Standard microbiologic techniques will be used to collect, culture, identify, and quantify ocular surface bacteria counts. Kruskal Wallis test will be used to assess significant difference between median bacterial loads at baseline and post-cleaning, as well as median reduction from baseline. Chi-squared test will be used to assess significant difference between reduction in number of patients with specific bacteria. Following injection, a patient survey will be administered to compare patients' subjective symptoms of ocular surface irritation during the PI preparation phase of the procedure.
Conclusions: The investigators anticipate that no significant difference exists in decrease of median CFUs between the three protocols, and that lower concentration of P-I provides a more comfortable patient experience.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5% Betadine, Ocular Surface only | Experimental | Biological: Bacterial Culture SwabUse of 5% P-I from bottle dropper to sterilize the ocular surface only, prior to injection. Intervention: bacterial culture swab. |
| 10% Betadine, Ocular Surface only | Experimental | Biological: Bacterial Culture SwabUse of 10% P-I swabstick to sterilize the ocular surface only, prior to injection. Intervention: bacterial culture swab. |
| 10% Betadine, Ocular Surface and Adnexa | Experimental | Biological: Bacterial Culture SwabUse of 10% P-I swabstick to sterilize the ocular surface and surrounding lids and eyelashes only, prior to injection. Intervention: bacterial culture swab. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- enrollment will be open to men and women of all ethnic backgrounds between the ages of 18-100 who are offered intravitreal injections by Dr. Anthony Mazzulla at his Retina clinic at the Ochsner Clinic Foundation as a treatment for diabetic macular edema, proliferative diabetic retinopathy, age related exudative macular degeneration, or any other cause of choroidal neovascularization or cystoid macular edema.
Key exclusion criteria (1 listed)
- Current eye infection, actively treated blepharitis, current use of topical or systemic antimicrobial agents, current use of topical or systemic corticosteroids, allergy to iodine, pregnancy, children.
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 |
|---|---|---|
| Bacterial Culture SwabCulture swabs will be obtained before application of PI and after injection. | Biological | 10% Betadine, Ocular Surface and Adnexa, 10% Betadine, Ocular Surface only, 5% Betadine, Ocular Surface only |
Primary outcome
Median Colony-Forming Units
Time frame: 3 months
Median CFUs compared pre- and post-injection
1 secondary outcome
Patient's ocular surface symptoms during sterilization with povidone-iodine
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Donald Mazzulla, MD principal investigator
Ochsner Health System
Questions about this trial
What is this clinical trial studying?
A study testing Bacterial Culture Swab in people with Endophthalmitis and Eye Infections, run by Matthew Bolton.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Bolton, MD (504-495-5631, mbolt3@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Colony-Forming Units (time frame: 3 months). 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 5 Feb 2018.