Recruiting
Early Phase 1

Chlorhexidine vs. Betadine

Sponsor:

MidAtlantic Retina

Code:

NCT03571100

Conditions

Age-related Macular Degeneration

Diabetic Vascular Diseases

Proliferative Retinopathy

Retina Vein Occlusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chlorhexidine

Povidine-Iodine

Study Details

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

Conditions

Age-related Macular Degeneration

Diabetic Vascular Diseases

Proliferative Retinopathy

Retina Vein Occlusion

Study ID

NCT03571100

Start date

May 7, 2018

Status verified date

Jun, 2018

Completion date

May 6, 2019

Anticipated

Primary completion date

May 6, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Povidine-Iodine

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

active comparator: Chlorhexidine

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

Interventions

Chlorhexidine

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

Povidine-Iodine

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

Primary outcome measure

  • Patient Comfort [ Time Frame: One day following injection ]

Central Contacts and Locations

Central contacts

Michele Formoso

215-928-3092research@midatlanticretina.com

Devida Long

215-928-3092research@midatlanticretina.com

Locations

MidAtlantic Retina

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Michele Formoso

215-928-3092research@midatlanticretina.com

Devida Long

215-928-3092research@midatlanticretina.com

Principal Investigator:

Sunir Garg, MD

More Information

Sponsor

MidAtlantic Retina

Last update posted

Jun 27, 2018

Last verified

Jun, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by MidAtlantic Retina on 2018-06-27.