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CataractsNCT01898728

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

A study testing topical povidone-iodine after premedication with topical liquid eye drops and topical povidone-iodine after premedication with topical gel in people with Cataracts, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataracts
What is being tested?
topical povidone-iodine after premedication with topical liquid eye drops and topical povidone-iodine after premedication with topical gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteCanada
Study dates
Dec 2012to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St. Joseph's Healthcare Hamilton King Campus

    Hamilton, Ontario, L8G5E4

Other trials in Canada

About this study

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.

Read the detailed description

The human eye contains a crystalline lens that focuses light onto the retina. A clouding of the lens is known as a cataract. Cataracts progressively decrease visual acuity and contrast sensitivity. Cataracts are the leading cause of blindness worldwide. The current standard of practice for treating cataracts is cataract extraction using phacoemulsification, an ultrasound technology to liquefy and aspirate the lens material, and the implantation of an intraocular lens (IOL) to clearly refocus light onto the retina. 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 life of patients.

Endophthalmitis is an intraocular inflammation involving both the anterior and posterior segments of the eye attributable to bacterial or fungal pathogens. Postoperative endophthalmitis is one of the most devastating complications of cataract surgery and despite aggressive treatment, only approximately half of patients achieve better than 20/40 vision and many patients remain no light perception (NLP). The majority of causative organisms are from the patient's skin and conjunctival flora, making preoperative reduction in conjunctival flora a key component of endophthalmitis prophylaxis. The Endophthalmitis Vitrectomy Study (EVS) revealed that 70% of infections are due to coagulase-negative Staphylococcus, 9.9% due to Staphylococcus aureus, 2.2% from Enterococcus, and 5.9% from Gram-negative bacteria. A recent systematic review evidenced a postoperative endophthalmitis rate of 0.265% from 2000 to 2003, compared with 0.087% in the previous decade. There are numerous theories to the increase in incidence, including a move to topical anaesthesia and change in wound construction techniques. It is difficult for prospective studies to be detect differences in the rate of endophthalmitis as the incidence is low. Currently, only topical povidone-iodine and intracameral antibiotics (cefuroxime, vancomycin, and moxifloxacin) have been shown to decrease the rate of endophthalmitis.

Prior to cataract surgery while in the preoperative area, patients receive a number of eye drops, frequently including antibiotics, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anaesthetics and mydriatics/cycloplegics. Many surgical centres, including the Regional Eye Institute at the St. Joseph's Centre for Ambulatory Care have a pharmacy-prepared combination of the above medications in a viscous gel, such that the medications remain on the ocular surface for a prolonged period of time thus enhancing efficacy.

Topical lidocaine gel is an anaesthetic that is used prior to cataract surgery in many institutions.Studies demonstrating that the antiseptic effect of topical povidone-iodine may be inhibited by topical lidocaine gel have been published. Boden et al. performed a basic science study inoculating culture media with bacteria and then exposing them to topical lidocaine gel, topical povidone-iodine or topical povidone-iodine after lidocaine gel. Their results revealed that the antiseptic effect of povidone-iodine was inhibited by previous treatment with lidocaine gel. Moreover, a retrospective observational case series found that 2 of 7 cases of postoperative endophthalmitis occurred after topical lidocaine gel use. Most recently, Doshi et al. in the laboratory setting confirmed the inhibitory effect of lidocaine gel prior to povidone-iodine and also revealed that if povidone-iodine was applied prior to lidocaine gel, the iodine was able to act as an antiseptic as usual.

The previous studies reveal that there may be an inhibition of the antiseptic effect of povidone-iodine when topical lidocaine gel is applied first in the laboratory setting. This has not been shown clinically.

Conditions
Cataracts
Being tested
topical povidone-iodine after premedication with topical liquid eye drops, topical povidone-iodine after premedication with topical gel
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • topical povidone-iodine after premedication with topical liquid eye dropsDrug

  • topical povidone-iodine after premedication with topical gelDrug

Study groups in NCT01898728
Study groupRoleWhat they receive
Liquid preoperative medicationsActive comparatorLiquid preoperative medications
Receives: Drug: topical povidone-iodine after premedication with topical liquid eye drops
Gel preoperative medicationsActive comparatorGel preoperative medications
Receives: Drug: topical povidone-iodine after premedication with topical gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of Colony Forming Units (CFUs)

    Measured: Period before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01898728
Sponsor's protocol ID
Lidocaine gel vs drops
Status last verified
Jul 2013
First submitted
7 Jul 2013
Last updated
22 Mar 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing topical povidone-iodine after premedication with topical liquid eye drops and topical povidone-iodine after premedication with topical gel in people with Cataracts, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of Colony Forming Units (CFUs) (time frame: Period before surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.

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