Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03192722 |
| Other study ID # |
2017-512 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2017 |
| Est. completion date |
May 31, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Nova Southeastern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The effect of tinted filters and illumination on the visual performance of patients with low
vision (i.e., individuals with reduced vision that is uncorrectable with glasses, surgery or
treatments) has been a topic of research and discussion for many years, yet there is no
current consensus or practice standard for the evaluation and recommendation of colored
filters and/or illumination intensity. Anecdotally, there have been many subjective reports
of improvement in visual function and comfort with the use of tinted lenses. Previous studies
have attempted to elucidate the subjective improvements observed using vision tests, such as
visual acuity and contrast sensitivity, and the findings have been inconsistent.
Traditionally, filters and optimal illumination are prescribed clinically through a trial and
error method, which involves trying various filters and lamps haphazardly to determine which
if any are preferred by the patient. The investigators are proposing to evaluate whether the
illumination and filters chosen in office by participants using a new assessment tool the
LuxIQ/2 translate to overall patient comfort and improved speed, accuracy and print size
while reading, and to evaluate whether participants have the same illumination and colored
filter preference determined by the LuxIQ/2 in a clinical office setting and in their home
environment. The investigators will evaluate whether participants prefer lighting determined
by the new assessment tool the LuxIQ/2 in comparison to lighting determined by the OttLite
Cobra in office.
Description:
All eligible patients with complaints of difficulty performing sustained reading tasks, such
as reading books or magazines, will be evaluated for their preference for filter color and
lighting using the LuxIQ/2.
Baseline distance visual acuity, contrast sensitivity, and near visual acuity, will be
evaluated during initial presentation to the clinic as part of usual care using validated
tests that are routinely performed during a low vision examination. Best-corrected distance
visual acuity will be determined using the ETDRS (Early Treatment for Diabetic Retinopathy
Study) chart. Contrast sensitivity will be evaluated using the MARS contrast sensitivity
chart. Best-corrected near visual acuity will be evaluated using the Lighthouse Continuous
Text Card. The LuxIQ/2 will be administered 3 times at 15-minute intervals. Lighting
preferences will be evaluated 3 times using the Ott Lite Cobra. Each subject will be asked to
choose between their preferred lighting conditions as determined by the OttLite Cobra and the
LuxIQ/2, i.e each participant ill choose which lighting conditions is preferred for reading.
The assessment tool (OTTLite Cobra or LuxIQ/2) which is performed first will be randomized
for each participant. Microperimetry (a type of visual field test) will be conducted on all
participants using the MAIA microperimeter at the NSU site only.
For subjects who do not appreciate an improvement in reading ability with a colored filter in
office, we will obtain their written informed consent to include data collected during the
clinical examination. For participants who do not appreciate an improvement in reading
ability with a colored filter, but who appreciate an improvement in reading ability with
white light as determined by the LuxIQ/2 in comparison to the OttLite Cobra, appropriate
light bulb and desk lanp will be provided as determined by the LuxIQ/2. For participants who
prefer the lighting determined using the Ottlite Cobra, they will be provided with an Ottlite
Cobra desk lamp as well as their preferred settings on the device as determined through the
in-office evaluation to be used at home. Participants to whom light bulb recommendations were
provided or the Ottlite Cobra was recommended to improve lighting for their reading tasks,
will be contacted by a research assistant 1 week after the in office assessment to complete a
telephone interview which will consist of an Activity inventory questionnaire which will
inquire about their difficulty performing near tasks using their previous light source as
well as Ramulu's sustained reading test. The Ramulu sustained reading test will be performed
twice during the phone interview, once with their previous lighting they were using at home
before they obtained the new reading lamp (where they do most of their reading) and again
with their new desk lamp. After 1 month, the research assistant will call the participant to
repeat the Activity questionnaire inquiring about ability to perform near tasks using the new
recommended lighting.
For participants who appreciate an improvement in reading ability with colored reading
glasses, we will obtain their written informed consent to join the longer-term study.
- Reading materials will be provided to participants in an enclosed envelope in office.
Participants will be asked to refrain from opening envelope until contacted by research
assistant. Other individuals who decide to participate at a later time after
contemplating the requirements of the research, will be sent the reading material in the
mail.
- A research assistant will contact subject 1 week after in office assessment to complete
telephone interview which will consist of the reading domain of the Activity Inventory
questionnaire and the modified Telephone Interview of Cognitive Status (TICS-M) and
silent reading test. During the call, subject will be asked to read several pages of a
short story to themselves, silently using their current reading glasses, not the new
ones that will be ordered. Subjects will be asked to answer a few questions about the
stories. This call should take about 30-60 minutes.
- Subjects will be provided with new prescription clear reading glasses. After 1 month a
research assistant will contact participant to repeat the same questionnaires and silent
reading test using a different short story.
- Within a month after the phone questionnaires, the PI will make an appointment to come
to the subject's home to test near vision and contrast sensitivity and determine
preference for filter in home environment. At this time, the PI may ask for the new pair
of clear reading glasses to take them to our optical to tint the lenses to the color
that is preferred by the subject.
- One group will obtain near vision glasses with color filter/tinted lenses immediately,
while the other group (controls) will continue to wear the clear reading glasses for
another 4 weeks and will then will crossover to obtain near vision glasses with the
filter/tinted lenses.
- About a month after wearing near reading glasses with the colored lenses, one of our
research assistants will call participant to repeat the same questionnaires and silent
reading test again using a different short story. This call should take about 30-45
minutes.
- At the end a low vision optometrist on the research team will contact participants to
ask some open-ended questions about what the participant thought about using the near
reading glasses with the colored lenses. This call should take about 15-30 minutes.
