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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192722
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Samantha McIntosh, Nova Southeastern University

Brief 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.

Condition or disease Intervention/treatment Phase
Ocular Conditions Resulting in Visual Impairment Device: Colored near reading glasses Device: Lighting as determined by LuxIQ/2 or OttLite Cobra Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Low Vision Patients' Preference for Colored Filters and Illumination for Near Reading Determined by the LuxIQ/2
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021


Arm Intervention/treatment
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.

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.

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)

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)




Primary Outcome Measures :
  1. Changes in Ramulu's sustained reading test [ Time Frame: 12 weeks ]
    Measurement based on time taking to complete reading sections

  2. Reading domain of Activity inventory [ Time Frame: 12 weeks ]
    Measured based on scale of difficulty performing tasks


Secondary Outcome Measures :
  1. Changes in near visual acuity [ Time Frame: 12 weeks ]
    measured in M notation

  2. Changes in contrast sensitivity [ Time Frame: 12 weeks ]
    measured in log units



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192722


Contacts
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Contact: Samantha McIntosh, OD 404-455-3636 sm1554@nova.edu

Locations
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United States, Florida
Nova Southeastern University Recruiting
Fort Lauderdale, Florida, United States, 33328
Contact: Samantha McIntosh, OD    404-455-3636    sm1554@nova.edu   
Contact: Ava Bittner, OD, PHD         
Sponsors and Collaborators
Nova Southeastern University
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Responsible Party: Samantha McIntosh, Assistant Professor, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT03192722    
Other Study ID Numbers: 2017-512
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samantha McIntosh, Nova Southeastern University:
Filters
Illumination
Low vision
Reading
Additional relevant MeSH terms:
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Vision Disorders
Vision, Low
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms