Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant

May 20, 2019 updated by: Asmaa mohammed mostafa, Assiut University
  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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: asmaa mohamed, master
  • Phone Number: 01065637228 01094109699
  • Email: am650124@gmail.com

Study Contact Backup

  • Name: Prof. Mohamed Tarek Abdel-Monaem Abdel-Monaem, pHD
  • Phone Number: 01007530025
  • Email: mtarekelc@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Comfort
Time Frame: day three post operative
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
Time Frame: 7 days
Microbial flora in conjunctival swab
7 days
Patient Comfort
Time Frame: I minute after disinfectant drop instilled
Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]
I minute after disinfectant drop instilled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

May 18, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHG vs PI in ophthalmology

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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