Disinfectant Causing Toxic Effect
Conditions
Brief summary
1. Is to assess the efficacy of preoperative disinfection with chlorohexidine and povidone iodine in different concentrations separately . 2. Is to compare the efficacy of chlorohexidine to povidone iodine. 3. Compare patient comfort after instillation of each disinfectant . 4. To find which disinfectant is more effective tolerated and more safe for use .
Detailed description
Methods: This is a single center prospective study comparing antiseptic efficacy and ocular surface irritation with PI (povidine iodine) and AC (aqueous chlorhexidine). . Prior to sugery patients who meet inclusion criteria will be identified and informed consent will be obtained. Study personnel will obtain two samples one from conjunctival sac and th other from skin around the eye. Topical antisepsis will then be applied, the first eye will be randomized to one drop of either PI 5% - 2.5% or AC 0.1%- 0.05% 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. After 15 minutes the second swabs will be taken in the same manner as the first swabs. . On post-operative day three, study personnel will meet the patient and ask to rate the pain in each eye using the same verbal numerical rating scale and to perform slit lamb examination for any complication.
Interventions
DRUGChlorhexidine
chlorhexidine administration prior to ophthalmic surgery (compared to Povidine iodine )
DRUGPovidone-Iodine
Povidine iodine administration prior to ophthalmic surgery (compared to chlorhexidine)
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The participant will be masked to which drug they receive, the investigator performing the analysis will also be masked
Intervention model description
Randomized prospective trial
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current patient of the Assiute University Hospital arranged for ophthamic surgery * Age greater than 12.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort | day three post operative | Patient Comfort using the Wong Baker FACES Pain Scale \[Scale: 0(No pain) - 10 (Worst Pain)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Culture of conjunctiva for bacteria | 7 days | Microbial flora in conjunctival swab |
| Patient Comfort | I minute after disinfectant drop instilled | Patient Comfort using the Wong Baker FACES Pain Scale \[Scale: 0(No pain) - 10 (Worst Pain)\] |
Contacts
Primary Contactasmaa mohamed, master
Backup ContactProf. Mohamed Tarek Abdel-Monaem Abdel-Monaem, pHD
Outcome results
None listed