Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant

Study Overview
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Brief Summary
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Is to assess the efficacy of preoperative disinfection with chlorohexidine and povidone iodine in different concentrations separately . Is to compare the efficacy of chlorohexidine to povidone iodine. Compare patient comfort after instillation of each disinfectant . To find which disinfectant is more effective tolerated and more safe for use .

Detailed Description
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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.

Official Title
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Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant

Conditions
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Disinfectant Causing Toxic Effect

Intervention / Treatment
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* Drug: Chlorhexidine
* Drug: Povidone-Iodine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized prospective trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Povidine-Iodine<br>patients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye before operation | Drug: Povidone-Iodine<br>* Povidine iodine administration prior to ophthalmic surgery (compared to chlorhexidine)<br>* Other names: betadine;|
| Active Comparator: chlorhexidine<br>patients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye before operation | Drug: Chlorhexidine<br>* chlorhexidine administration prior to ophthalmic surgery (compared to Povidine iodine )<br>* Other names: aqueous Chlorhexidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Comfort | Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)] | day three post operative | 

Secondary Outcome Measures

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