Laser Assisted Treatment of Chronic Sinusitis With and Without Light Activated Agents

Summary

Chronic rhinosinusitis (CRS) is common disorder which affects up to 13% of the US population. CRS affects numerous Quality of Life (QOL) factors including smell, sleep and communication. The common treatment for medically noncompliant CRS is Functional Endoscopic Sinus Surgery (FESS).

As the disease course is generally idle, prolonged medical treatment guidelines are for antibiotic treatment, prescribed accordingly following appropriately obtained nasal cultures, lasting weeks with or without additional topical or oral steroid treatment. While FESS success rate is a general notion, a failure rate of primary FESS is as high as 2-24%2, with a Cochrane review even suggesting that FESS though a safe procedure is of no benefit more than medical management.

With that in mind as we address the failed FESS, new bacteria emerge. The new bacteria in CRS are Coagulase-negative staphylococci were the most common isolates (36%), followed by Staphylococcus aureus (25%), Streptococcus viridans (8.3%), Corynebacterium (4.6%), and anaerobes (6.4%).

Patients not relieved by primary FESS demonstrate a significant rise in Pseudomonas and MRSA bacteria positive cultures. Moreover surgical success for patients with Staphylococcus aureus and Pseudomonas aeruginosa positive cultures is usually reduced.

Bacterial killing, by usage of light-activated agents such as Indocyanine Green (ICG) with exposure to the specific wavelength, eventually produces bacterial killing. Mechanisms primarily involved are production of reactive oxygen species (i.e. singlet oxygen and free radicals) which can then kill bacteria. ICG by itself does not have any bacterial killing effect.

Low level laser therapy (LLLT) was shown to be effective as a bactericidal by single and multiple wave exposures.

The study purpose is to treat CRS with an alternative to antibiotics, thus sparing volunteers from prolonged antibiotics use and its possible side effects, not to mention the cost and growth of resistant bacteria. We believe that by combining ICG with light or even by light alone we can produce you a beneficial effect. Although this has been shown to kill bacteria in lab or animal studies it is still investigational for humans. The study will have two arms: ICG + laser and laser only arm. ICG will be applied locally in the nasal passage (internally) followed by laser activation with a power setting of 6W. The laser will be activated with a diffuser mode meaning light of a specific known wavelength will be delivered evenly in the nasal cavity and not as a beam. Laser only treatment plan will be the same only without ICG. Volunteers will be assigned to one of the groups randomly meaning you have a 50% chance of enrolling to each treatment group. Volunteers will not know to which group. Weekly visits with a total of three visits will follow. With each visit Volunteers will receive additional treatment as the initial treatment was and a nasal culture will be taken. Volunteers will have to fill a questionnaire with each visit.

Conditions

• Rhinosinusitis

Interventions

DEVICE

Laser + ICG

ICG arm- will be defined as local application on a pledget soaked with ICG with a concentration of 200µg, upon removal of the pledget a NIR diode laser set at 6W with light emittance introduced intranasally with a 30mm diffuser fiber capable of radiating light circumferentially allowing the light energy to reach all treatable areas. Laser will be activated for 180 seconds. Assuming an approximate radius of the nasal cavity is 3mm, energy density will be around 200J/cm². Treatment will be repeated twice, 5-7 day apart. Cultures will be collected at the end of all treatments

DEVICE

Laser only

same only without ICG

Sponsors & Collaborators

• Valam Corp.

  collaborator INDUSTRY

• New York Head & Neck Institute

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-05-31

Primary Completion

2011-12-31

Completion

2011-12-31

Countries

• United States

Study Locations