Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant
1 other identifier
interventional
100
0 countries
N/A
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2019
Typical duration for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 21, 2019
May 1, 2019
3 years
May 18, 2019
May 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Comfort
Patient Comfort using the Wong Baker FACES Pain Scale \[Scale: 0(No pain) - 10 (Worst Pain)\]
day three post operative
Secondary Outcomes (2)
Culture of conjunctiva for bacteria
7 days
Patient Comfort
I minute after disinfectant drop instilled
Study Arms (2)
Povidine-Iodine
ACTIVE COMPARATORpatients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye before operation
chlorhexidine
ACTIVE COMPARATORpatients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye before operation
Interventions
chlorhexidine administration prior to ophthalmic surgery (compared to Povidine iodine )
Povidine iodine administration prior to ophthalmic surgery (compared to chlorhexidine)
Eligibility Criteria
You may qualify if:
- Current patient of the Assiute University Hospital arranged for ophthamic surgery
- Age greater than 12.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
PMID: 28984794BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participant will be masked to which drug they receive, the investigator performing the analysis will also be masked
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asmaa Mohamed Mostafa
Study Record Dates
First Submitted
May 18, 2019
First Posted
May 21, 2019
Study Start
August 1, 2019
Primary Completion
August 1, 2022
Study Completion
December 1, 2022
Last Updated
May 21, 2019
Record last verified: 2019-05