Comparison of the Effectiveness of Povidone-iodine in Reducing Conjunctival Bacterial Load Prior to Cataract Surgery in Patients Treated With a Lidocaine Gel Dilating Formulation Versus Eye Drops: A Randomized Controlled Trial

NCT01898728 | Completed

• 1 other identifier: Lidocaine gel vs drops
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The eye contains a lens that focuses light. A clouding of the lens is known as a cataract. Cataracts decrease vision. The treatment for cataracts is cataract surgery. Cataract surgery is one of the most commonly performed surgical procedures. Although rare, complications of cataract surgery are significant given the number of people who have surgery each year and more serious complications may have a significant impact on the vision and quality of patients. Endophthalmitis is an infection in the eye and it is one of the worst complications of cataract surgery. Most of these infections are caused by bacteria from the patient's skin and conjunctiva, which makes cleaning the skin and eye before surgery very important. Before cataract surgery, patients receive an umber of eye drops; many surgical centers have a combination of medications in a thick gel, so that the medications remain in the eye for a long period of time, which may improve their effect. Laboratory studies suggest that the antibacterial effect of cleaning solutions may be inhibited by gels but this has not been proven, and many believe it to be untrue. This study is to compare the amount of bacteria on the eye prior to surgery in patients receiving a gel formulation of the medications before surgery as compared to those receiving the same medication in eye drop (liquid) form.

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

• The number of Colony Forming Units (CFUs)

  Period before surgery

Study Arms (2)

Liquid preoperative medications

ACTIVE COMPARATOR

Liquid preoperative medications

Drug: topical povidone-iodine after premedication with topical liquid eye drops

Gel preoperative medications

ACTIVE COMPARATOR

Gel preoperative medications

Drug: topical povidone-iodine after premedication with topical gel

Interventions

topical povidone-iodine after premedication with topical liquid eye drops DRUG

Liquid preoperative medications

topical povidone-iodine after premedication with topical gel DRUG

Gel preoperative medications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged greater than 18 years
• Able to give informed consent
• Undergoing uncomplicated cataract surgery

You may not qualify if:

• Hypersensitivity to any of the components of the premedication
• Hypersensitivity to povidone-iodine

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton King Campus

Hamilton, Ontario, L8G5E4, Canada

Location

MeSH Terms

Conditions

Cataract

Interventions

Gels

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2013
• First Posted: July 12, 2013
• Study Start: December 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 22, 2018

Record last verified: 2013-07

Locations

CA (1)