Laser Assisted Treatment of Chronic Sinusitis With and Without Light Activated Agents
| Status: | Completed |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | May 2009 |
| End Date: | December 2011 |
| Contact: | Yosef Krespi, MD |
| Email: | hnsg@aol.com |
| Phone: | 12122624444 |
Laser Microbial Killing With Photo Activated Agents
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.
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.
A prospective randomized trial that will be performed over the period of 1 year or until 20
patients in each arm meeting inclusion criteria will be recruited. One arm will be treated
with a NIR laser (ARC Lasers Gmbh, Germany) alone and another arm will have an ICG+ NIR
laser treatment.
FDA approved NIR lasers in the range of 810- 980nm. FDA approved ICG (Akorn, Buffalo Grove,
IL) applied locally total application will not exceed 2.5 mg Randomization method: first
five volunteers will start the ICG+ laser followed by five from only laser treatment group.
This will be followed by allocating one volunteer to each study arm alternatively.
Data to be collected: demographical data including age and gender, approximate duration of
symptoms, culture results, SNOT 20 (QOL questionnaire) score.
Urine test will be done to rule out pregnancy prior to study enrollment. Treatment: 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.
Non-ICG arm: same as above but without ICG appliance. Follow up will consist of an office
visit upon end of treatment with an additional visit scheduled two weeks later Protective
equipment: specifically designed eye goggles, draping preventing clothes stains from the dye
patients in each arm meeting inclusion criteria will be recruited. One arm will be treated
with a NIR laser (ARC Lasers Gmbh, Germany) alone and another arm will have an ICG+ NIR
laser treatment.
FDA approved NIR lasers in the range of 810- 980nm. FDA approved ICG (Akorn, Buffalo Grove,
IL) applied locally total application will not exceed 2.5 mg Randomization method: first
five volunteers will start the ICG+ laser followed by five from only laser treatment group.
This will be followed by allocating one volunteer to each study arm alternatively.
Data to be collected: demographical data including age and gender, approximate duration of
symptoms, culture results, SNOT 20 (QOL questionnaire) score.
Urine test will be done to rule out pregnancy prior to study enrollment. Treatment: 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.
Non-ICG arm: same as above but without ICG appliance. Follow up will consist of an office
visit upon end of treatment with an additional visit scheduled two weeks later Protective
equipment: specifically designed eye goggles, draping preventing clothes stains from the dye
Inclusion Criteria:
- Patients over 18
- Patients with an established nasal culture of either
- Staph aureus,
- Strep species,
- Pseudo monasaureginosa,
- Proteus.mirabilis,
- H. influenza
- or other intranasal pathogens.
Exclusion Criteria:
- Patients without CRS,
- Patients known to have Iodide allergy or ICG allergy
- Patients scheduled for a thyroid scan
- Pregnant or breastfeeding.
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