Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant

Early Phase 1

• Conditions: Disinfectant Causing Toxic Effect
• Interventions: Drug: Chlorhexidine; Drug: Povidone-Iodine

• Registration Number: NCT03957291
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-18
• Study First Submitted QC: 2019-05-20
• Last Update Submitted: 2019-05-20
• Study First Posted: 2019-05-21
• Last Update Posted: 2019-05-21
• Study Start: 2019-08
• Primary Completion: 2022-08
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chlorhexidine	Chlorhexidine	patients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye before operation
Povidine-Iodine	Povidone-Iodine	patients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye before operation

Primary Outcome Measures

Name	Time	Method
Patient Comfort	day three post operative	Patient Comfort using the Wong Baker FACES Pain Scale \[Scale: 0(No pain) - 10 (Worst Pain)\]

Secondary Outcome Measures

Name	Time	Method
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 \[Scale: 0(No pain) - 10 (Worst Pain)\]