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Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03957291
Collaborator
(none)
100
Enrollment
2
Arms
40
Anticipated Duration (Months)

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized prospective trialRandomized prospective trial
Masking:
Single (Participant)
Masking Description:
The participant will be masked to which drug they receive, the investigator performing the analysis will also be masked
Primary Purpose:
Prevention
Official Title:
Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant
Anticipated Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Culture of conjunctiva for bacteria [7 days]

      Microbial flora in conjunctival swab

    2. Patient Comfort [I minute after disinfectant drop instilled]

      Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Asmaa mohammed mostafa, Asmaa Mohamed Mostafa, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03957291
    Other Study ID Numbers:
    • CHG vs PI in ophthalmology
    First Posted:
    May 21, 2019
    Last Update Posted:
    May 21, 2019
    Last Verified:
    May 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Chlorhexidine
    Chlorhexidine gluconate
    Povidone-Iodine
    Povidone

    Study Results

    No Results Posted as of May 21, 2019