Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant

Disinfectant Causing Toxic Effect Clinical Trial

Official title:

Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03957291
• Other study ID #: CHG vs PI in ophthalmology
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: August 2019
• Est. completion date: December 2022

Study information

• Verified date: May 2019
• Source: Assiut University
• Contact: asmaa mohamed, master
• Phone: 01094109699
• Email: am650124[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disinfectant Causing Toxic Effect

Intervention

Drug:
• Chlorhexidine
chlorhexidine administration prior to ophthalmic surgery (compared to Povidine iodine )
• Povidone-Iodine
Povidine iodine administration prior to ophthalmic surgery (compared to chlorhexidine)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Grzybowski A, Kanclerz P, Myers WG. The use of povidone-iodine in ophthalmology. Curr Opin Ophthalmol. 2018 Jan;29(1):19-32. doi: 10.1097/ICU.0000000000000437. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Comfort	Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]	day three post operative
Secondary	Culture of conjunctiva for bacteria	Microbial flora in conjunctival swab	7 days
Secondary	Patient Comfort	Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]	I minute after disinfectant drop instilled