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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidine-Iodine | Active Comparator | Bilateral injections patients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye |
|
| Chlorhexidine | Active Comparator | Bilateral injections patients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Drug | Chlorhexidine administration prior to intravitreal injection (compared to gold standard povidine-iodine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Comfort | Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)] | One day following injection |
| Measure | Description | Time Frame |
|---|---|---|
| Culture of conjunctiva for bacteria | Microbial flora | 7 days |
| Patient Comfort | Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Formoso | Contact | 215-928-3092 | research@midatlanticretina.com | |
| Devida Long | Contact | 215-928-3092 | research@midatlanticretina.com |
| Name | Affiliation | Role |
|---|---|---|
| Sunir Garg, MD | MidAtlantic Retina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MidAtlantic Retina | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33221515 | Derived | Ali FS, Jenkins TL, Boparai RS, Obeid A, Ryan ME, Wibblesman TD, Chiang A, Garg SJ; Post-Injection Endophthalmitis Study Group. Aqueous Chlorhexidine Compared with Povidone-Iodine as Ocular Antisepsis before Intravitreal Injection: A Randomized Clinical Trial. Ophthalmol Retina. 2021 Aug;5(8):788-796. doi: 10.1016/j.oret.2020.11.008. Epub 2020 Nov 20. |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D003925 | Diabetic Angiopathies |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007466 |
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Randomized prospective trial
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The participant will be masked to which drug they receive, the investigator performing the analysis will also be masked
| Povidine-Iodine | Drug | Povidine iodine administration prior to intravitreal injection (compared to chlorhexidine) |
|
|
| I minute after drop instilled |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |