Dry Eye
Conditions
Keywords
Povidone-iodine, Pain
Brief summary
Objective and subjective comparison between the use of povidone-iodine 1% vs 5% as antiseptic in patients that need anti-VEGF intravitreal injection
Detailed description
Randomized, prospective clinical trial. One group was intervened with povidone-iodine at 5% and the other at 1% as antiseptic for anti-VEGF intravitreal injection. Each patient was evaluated before and after the injection of anti-VEGF for tear break up time, bulbar redness and ocular surface satining with fluorescein. Pain perception was also evaluated 15 minutes after the injection and 48 hours after.
Interventions
PROCEDUREChange of normal concentration of povidone-iodine 5% to 1%
Normal concentration of povidone-iodine during anti-VEGF intravitreal injection was 5%. That concentration was utilized in the control group, and 1% in the experimental group.
Sponsors
José Gerardo García Aguirre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Patients did not know which percentage of povidone-iodine was utilized during their injection. Tear breaking time and bulbar redness were automized results by Keraatopgrah. Oxford scale pre and post injection was staged by an investigator that did not know the group in which the patient was.
Intervention model description
Clinical, prospective, randomized trial. Pre anti-VEGF intravitreal injection, with OCULUS Keratopgrapph 5M topograph, non invasive tear breaking time, bulbar redness, and Oxford scale with fluorescein staining were measured. During anti-VEGF injection, tetracaíne was use as anestetic. Povidone-iodine 1% or 5% was randomized as antiseptic. After anti-VEGF intravitreal injection, patients were examined again for tear bkreaking time, bulbar redness and Oxford sacle, plus pain 15 minutes after injection. Finally, two days after the injection, patients were interviwed by telephone about their pain.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Having anti-VGEF intravitreal injection scheduled * Informed consent signed
Exclusion criteria
* Under 45 years * Opacity that prevents ophthalmological evaluation and fixation * Patients with severe dry eye * Patients with signs of infection on the ocular surface * Allergy to iodine * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear breaking rupture | Change from baseline measured to 15 minutes post-injection | NIKBUT was measured with Keratopgraph before and after intravitreal injection |
| Bulbar redness | Change from baseline measured to 15 minutes post-injection | Bulbar redness was measured with Keratopgraph before and after intravitreal injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford scale | Change from baseline measured to 15 minutes post-injection | Oxford scale was measured with fluorescein stain before and after intravitreal injection |
| Pain analog scale | Change from baseline measured to 15 minutes post-injection | Pain using visual analog scale was measured 15 minutes and 48 hours after intravitreal injection |
Countries
Mexico
Outcome results
None listed