NCT03571100

Brief Summary

The purpose of this prospective interventional study is to compare patient experience, ocular surface irritation, and bacterial colony counts and microbial spectrum between povidine iodine and aqueous chlorhexidine as ocular surface antiseptic prior to intravitreal injection

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2019

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

12 months

First QC Date

May 10, 2018

Last Update Submit

June 25, 2018

Conditions

Age-related Macular DegenerationDiabetic Vascular DiseasesProliferative RetinopathyRetina Vein Occlusion

Outcome Measures

Primary Outcomes (1)

  • Patient Comfort

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

    One day following injection

Secondary Outcomes (2)

  • Culture of conjunctiva for bacteria

    7 days

  • Patient Comfort

    I minute after drop instilled

Study Arms (2)

Povidine-Iodine

ACTIVE COMPARATOR

Bilateral injections patients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye

Drug: Povidine-Iodine

Chlorhexidine

ACTIVE COMPARATOR

Bilateral injections patients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye

Drug: Chlorhexidine

Interventions

ChlorhexidineDRUG

Chlorhexidine administration prior to intravitreal injection (compared to gold standard povidine-iodine)

Also known as: Aqueous chlorhexidine
Chlorhexidine
Povidine-IodineDRUG

Povidine iodine administration prior to intravitreal injection (compared to chlorhexidine)

Also known as: Betadine
Povidine-Iodine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current patient of the Wills Eye Hospital Retina Service including all Mid Atlantic Retina offices
  • Clinical indication of bilateral intravitreal injection as determined by the treating retina specialist for a diagnosis of age-related macular degeneration, diabetic macular edema, proliferative retinopathy or macular edema associated with retina vein occlusion.
  • Age greater than 18.

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

Study Sites (1)

MidAtlantic Retina

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (1)

  • Ali FS, Jenkins TL, Boparai RS, Obeid A, Ryan ME, Wibblesman TD, Chiang A, Garg SJ; Post-Injection Endophthalmitis Study Group. Aqueous Chlorhexidine Compared with Povidone-Iodine as Ocular Antisepsis before Intravitreal Injection: A Randomized Clinical Trial. Ophthalmol Retina. 2021 Aug;5(8):788-796. doi: 10.1016/j.oret.2020.11.008. Epub 2020 Nov 20.

    PMID: 33221515DERIVED

MeSH Terms

Conditions

Macular DegenerationDiabetic Angiopathies

Interventions

ChlorhexidinePovidone-Iodine

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsIodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Sunir Garg, MD

    MidAtlantic Retina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Formoso

CONTACT

215-928-3092research@midatlanticretina.com

Devida Long

CONTACT

215-928-3092research@midatlanticretina.com

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
Model Details: Randomized prospective trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Sunir Garg MD

Study Record Dates

First Submitted

May 10, 2018

First Posted

June 27, 2018

Study Start

May 7, 2018

Primary Completion

May 6, 2019

Study Completion

May 6, 2019

Last Updated

June 27, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)