Comfort and Antimicrobial Efficacy of Chlorhexidine vs Betadine for Intravitreal Injections

June 25, 2018 updated by: MidAtlantic Retina

Patient Comfort and Antimicrobial Efficacy With Aqueous Chlorhexidine Versus Povidine-Iodine (Betadine) as Ocular Surface Disinfectant Prior to Intravitreal Injection

The purpose of this prospective interventional study is to compare patient experience, ocular surface irritation, and bacterial colony counts and microbial spectrum between povidine iodine and aqueous chlorhexidine as ocular surface antiseptic prior to intravitreal injection

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a single center prospective study comparing antiseptic efficacy and ocular surface irritation with PI (povidine iodine) and AC (aqueous chlorhexidine). Patients will be recruited in the clinical offices of the Retina Service of Wills and Hospital/Mid Atlantic Retina clinic offices. Patients who are determined to require bilateral intravitreal injections of an anti-VEGF (vascular endothelial growth factor) agents by a retina specialist at their regularly scheduled retina appointment will be evaluated for qualification by study personnel. Patients who meet inclusion criteria will be identified and informed consent will be obtained. Prior to injection, topical anesthetic (0.5% proparacaine, Alcon) will be instilled in both eyes. Study personnel will obtain four samples from the superior and inferior fornices of the upper and lower lids of both eyes using swabs (COPAN ESwab, ThermoFisher Scientific) for patients enrolled at Wills. Topical antisepsis will then be applied, the first eye will be randomized to one drop of either PI 5% or AC 0.1% and the second eye will receive the other agent. One minute after instillation of the eye drop to each eye, patients will rate their pain in each eye using the Wong-Baker (smiley face) rating scale. The injections will then be performed by the treating retina specialist. Following the injection, a second conjunctival culture will be taken in an identical manner to the first for patients enrolled at Wills. Study personnel will then instill fluorescein dye (fluorescein sodium ophthalmic, BioGlo) into each eye, and a brief slit lamp examination will be performed. Study personnel will record surface findings according to the Ocular Surface Score and a numerical score for each eye will be determined. On post-injection day one study personnel will call the patient and ask to rate the pain in each eye using the same verbal numerical rating scale. No additional clinic visits will be required as part of the study.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current patient of the Wills Eye Hospital Retina Service including all Mid Atlantic Retina offices
  • Clinical indication of bilateral intravitreal injection as determined by the treating retina specialist for a diagnosis of age-related macular degeneration, diabetic macular edema, proliferative retinopathy or macular edema associated with retina vein occlusion.
  • Age greater than 18.

Exclusion Criteria:

  • Documented allergy to PI or AC
  • Current diagnosis of infectious keratitis
  • History of unilateral contact lens wear in the past 30 days
  • Current unilateral use of prescription eye drops.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Povidine-Iodine
Bilateral injections patients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye
Drug: Povidine-Iodine
Povidine iodine administration prior to intravitreal injection (compared to chlorhexidine)
Other Names:
  • Betadine
Active Comparator: Chlorhexidine
Bilateral injections patients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye
Drug: Chlorhexidine
Chlorhexidine administration prior to intravitreal injection (compared to gold standard povidine-iodine)
Other Names:
  • Aqueous chlorhexidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Comfort
Time Frame: One day following injection
Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]
One day following injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Culture of conjunctiva for bacteria
Time Frame: 7 days
Microbial flora
7 days
Patient Comfort
Time Frame: I minute after drop instilled
Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]
I minute after drop instilled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MidAtlantic Retina

Investigators

  • Principal Investigator: Sunir Garg, MD, MidAtlantic Retina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2018

Primary Completion (Anticipated)

May 6, 2019

Study Completion (Anticipated)

May 6, 2019

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-692E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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