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Trial record 3 of 36 for:    Recruiting, Not yet recruiting, Available Studies | "Vision, Low"

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

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ClinicalTrials.gov Identifier: NCT03192722
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ava Bittner, OD, PhD, 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.

Condition or disease Intervention/treatment Phase
Ocular Conditions Resulting in Visual Impairment Device: Colored near reading glasses Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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.




Primary Outcome Measures :
  1. Changes in Ramulu's sustained reading test [ Time Frame: 12 weeks ]
  2. Reading domain of Activity inventory [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Changes in near visual acuity [ Time Frame: 12 weeks ]
  2. Changes in contrast sensitivity [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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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

Exclusion Criteria:

  • Subjects who reside in areas outside of Broward and Palm Beach Counties
  • 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

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


Locations
United States, Florida
Nova Southeastern University Recruiting
Fort Lauderdale, Florida, United States, 33328
Contact: Samantha McIntosh, OD    561-309-3800    sm1554@nova.edu   
Contact: Ava Bittner, OD, PHD    954-262-1470      
Sponsors and Collaborators
Nova Southeastern University

Responsible Party: Ava Bittner, OD, PhD, Associate Professor, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT03192722     History of Changes
Other Study ID Numbers: 2017-512
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ava Bittner, OD, PhD, Nova Southeastern University:
Filters
Illumination
Low vision
Reading

Additional relevant MeSH terms:
Vision, Low
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors