Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant

Assiut University

Status and phase: Unknown; Early Phase 1

Conditions: Disinfectant Causing Toxic Effect

Treatments: Drug: Povidone-Iodine; Drug: Chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03957291

CHG vs PI in ophthalmology

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Povidine-Iodine

Active Comparator group

Description:

patients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye before operation

Treatment:

Drug: Povidone-Iodine

chlorhexidine

Active Comparator group

Description:

patients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye before operation

Treatment:

Drug: Chlorhexidine