Comfort and Antimicrobial Efficacy of Chlorhexidine vs Betadine for Intravitreal Injections
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/29/2018 |
| Start Date: | May 7, 2018 |
| End Date: | May 6, 2019 |
| Contact: | Michele Formoso |
| Email: | research@midatlanticretina.com |
| Phone: | 215-928-3092 |
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
surface irritation, and bacterial colony counts and microbial spectrum between povidine
iodine and aqueous chlorhexidine as ocular surface antiseptic prior to intravitreal injection
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.
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.
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.
We found this trial at
1
site
Philadelphia, Pennsylvania 19107
Principal Investigator: Sunir Garg, MD
Phone: 215-928-3092
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