Low Vision Patients' Preference for Colored Filters and Illumination for Near Reading Determined by the LuxIQ/2

March 27, 2024 updated by: So Yeon Lee, Nova Southeastern University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Samantha McIntosh, OD
  • Phone Number: 404-455-3636
  • Email: sm1554@nova.edu

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33328
        • Nova Southeastern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects who express a desire to obtain filters in a pair of near reading glasses
  • Age 18 and older
  • Provide informed consent
  • Complaints of difficulty performing sustained reading tasks, such as reading books or magazines
  • Patients who are interested in obtaining preferred filters in a pair of reading glasses
  • Patients who have completed an evaluation in the low vision service of the NSU The Eye Care Institute or Lighthouse of Broward or UCLA Stein Eye Institute

Exclusion Criteria:

  • Subjects with a score less than 21 on the TICS-M
  • Subjects diagnosed with Dry Eye Syndrome determined by clinical signs, history of or current topical prescription medication (i.e., Restasis or Xiidra) usage, or the usage of other dry eye treatment including punctal plugs, instillation of artificial tears more than once per day and advanced dry eye treatment
  • Subjects with poor vision who would require electronic magnification or non-visual devices
  • Patients with poor vision for whom clinical management strategy would not involve tinted reading glasses and a lamp

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate exposure to near vision glasses with filters
Participants immediately provided with near vision glasses with colored filters
Device: Colored near reading glasses
Participants are provided with colored near vision glasses.
Other: Delayed exposure to near vision glasses with filters
Participants provided with near vision glasses with colored filters after 8 weeks of wearing clear near vision glasses
Device: Colored near reading glasses
Participants are provided with colored near vision glasses.
Other: Immediate exposure to LuxIQ/2
Participants are examined with LuxIQ/2 to determine preferred lighting as determined by device followed by examination with OttLite Cobra
Device: Lighting as determined by LuxIQ/2 or OttLite Cobra
Participants are provided preferred lighting (either OttLite or lamp with findings from LuxIQ/2)
Other: Immediate exposure to OttLite Cobra
Participants are examined with OttLite Cobra to determine preferred lighting followed by LuxIQ/2
Device: Lighting as determined by LuxIQ/2 or OttLite Cobra
Participants are provided preferred lighting (either OttLite or lamp with findings from LuxIQ/2)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Ramulu's sustained reading test
Time Frame: 12 weeks
Measurement based on time taking to complete reading sections
12 weeks
Reading domain of Activity inventory
Time Frame: 12 weeks
Measured based on scale of difficulty performing tasks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in near visual acuity
Time Frame: 12 weeks
measured in M notation
12 weeks
Changes in contrast sensitivity
Time Frame: 12 weeks
measured in log units
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Southeastern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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