Participants who meet inclusion and exclusion criteria will be enrolled into the study
after consenting. Patients will be interviewed and asked to provide their history of
present conditions, past medical history, if they are on disability or receiving
compensation for an injury, demographic information, and ethnic group (determined by
self-identification). Additionally, patients will undergo a physical examination. The
focus will be on the history of colorblindness and chronic pain. A pain assessment will
be conducted, and this will be obtained verbally from the patient. Physical examinations
will be obtained at the initial study visit and will be documented in the source
documents.
The participants will be instructed to use the GLED or the WLED devices as follows:
Before surgery - The participants will be instructed to choose rooms in their home. These
rooms must be dark and has no other source of light except the light device provided. The
participants will be instructed to place the devices in their fields of vision and keep
it between 3 feet away from their eyes. This distance is chosen based on the intensity of
the light from our clinical trial, which corresponds to 100 lux. The participants will be
asked not to stare directly at the light, but to rather allow it to enter their eyes from
the periphery and to treat it as they would treat any other light fixture. The
participants will be asked to have 2 hours of exposure every night. Given that
participants may have different preferred time to go to bed, we will ask them to start
the exposure any time after sunset when sunshine is no longer illuminating their chosen
rooms for exposure. We will encourage the participants to participate in any activities
that do not require additional lights so they do not fall asleep during the nightly light
exposure. For example, the participants may enjoy reading (100 lux provide enough
illumination for reading), listening to music, exercising, etc. The participants will be
exposed nightly to their light for 8 weeks prior to surgery.
After Surgery - On average, half the participants may be discharged home from the
hospital after they recover from anesthesia in the same day. The other half of the
participants may be admitted to the hospital for 1-3 days on average based on their
medical profile, the course of the surgery, and any complications or concerns of the
surgeons or the anesthesiologists. For patients that will be discharged home on the same
day, they will continue light exposure as they did before surgery. For patients who may
be admitted to the hospital, we have already secured the approval from the hospital
administrative staff as well as the nursing manager to allow the participants to utilize
the light devices in the patients' rooms. The light devices were examined by the Facility
Management (for electrical hazards) and Infection Control and both approved the use of
the light devices in the hospital setting. The participants will place the light devices
in their fields of vision in the patients' rooms. Patients and nurses are able to control
the ambient lights in the rooms and it will be kept dark except for the light from the
light devices for two hours every night. The participants will be exposed to the light
for 2 hours in the evening prior to sleeping. If the surgery is scheduled late at night
or if the participants has a slow emergence from anesthesia, they may not be awake during
the first night in the hospital to have the light exposure. Once participants are
discharged from the hospital, they will continue exposure to the light as they did before
surgery for the remainder of the two weeks postoperatively.
Data Management:
Data will be collected on standardized case report forms and entered into a
HIPPA-compliant electronic database (e.g. Microsoft Access) that provides an appropriate
interface with a robust statistical package . All study-related hard copy materials will
be stored in locked file cabinets.