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Clinical Effectiveness of Low Vision Rehabilitation in Glaucoma Patients (LOVIT)

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. Read our disclaimer for details. Identifier: NCT01262209
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : September 9, 2016
Information provided by (Responsible Party):
Cindy Hutnik, Lawson Health Research Institute

Brief Summary:

Our team is interested in what can be done to improve the functioning of patients who suffer from glaucoma, a chronic and irreversible eye disease. Patients with vision loss as a result of this disease may feel like they have been 'given up on', or lost to our medical system when no further interventions can be offered to treat their eye disease. It is our intent to investigate what alternatives we can provide our patients, instead of simply saying, 'nothing more can be done'. We have learned from studies done on other chronic eye diseases, like age related macular degeneration, that low vision rehabilitation can improve visual function.

What exactly is low vision? It can involve a loss of visual acuity, making activities such as reading or writing a challenge; it can involve loss of contrast sensitivity, making shapes and edges hard to discern, like those of a stair edge, or person's face. It could also involve a loss of peripheral, or side vision which is a symptom common to most glaucoma patients. Whatever the cause of low vision, doing day-to-day activities can become increasingly difficult, and many suffer from a loss of their independence and may even become depressed. Low vision rehabilitation involves helping patients to use their remaining vision in optimal, and sometimes even new, ways. This involves an assessment of a person's baseline vision, and an idea of what their needs are. Patients are then given low vision aids (such as magnifiers, telescopes, video screens which magnify images, and other tools) as well as instructions and support for adapting to living and functioning with altered vision.

Although there currently exists no cure for glaucoma, and we are certainly not promising a reversal of the damage done to the eyes from this chronic disease, we do believe that these types of rehabilitation services may offer some hope and potential visual benefit to patients living with vision loss. Our hypothesis is that the use of state-of-the-art low vision aids in patients with advanced glaucomatous visual loss will provide an improvement in visual tasks and thereby an improvement in quality of life.

Condition or disease Intervention/treatment Phase
Glaucoma Device: portable CCTV Device: Telescopes, telemicroscopes and microscopes Device: Absorptive filters Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Effectiveness of Low Vision Rehabilitation in Glaucoma Patients With Moderate or Severe Vision Loss
Study Start Date : May 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Low Vision Aids

All patients will receive:

  1. A low vision examination:

    1. Low vision refraction
    2. Distance best corrected visual acuity
    3. Near best corrected visual acuity
    4. Contrast Sensitivity
    5. Quality of life questionnaire
  2. Low vision therapy: to teach strategies for more effective use of remaining vision and use of low-vision devices
  3. Prescribed low vision devices including binocular telescope (2.1x or 3.5x), monocular telescope, 6x telemicroscopes, microscopes, magnifiers, portable CCTV and absorptive filters.
Device: portable CCTV
This is a small handheld mini screen intended to improve reading.

Device: Telescopes, telemicroscopes and microscopes
These are either worn like glasses, or held in one's hand and are intended to improve distance vision (like details of a hockey game), intermediate vision (like reading a sign), or 'up-close' vision (like reading small print).

Device: Absorptive filters
These are worn like glasses, and have tinted colour lenses. They are intended to improve contrast sensitivity, or being able to tell light from dark (like reading gray letters on a white background).

Primary Outcome Measures :
  1. Visual reading ability and visual mobility. [ Time Frame: 2 weeks ]
    The primary outcome measure will be visual reading ability and visual mobility.

Secondary Outcome Measures :
  1. Other visual ability domains. [ Time Frame: 2 weeks ]
    Mean changes in other visual ability domains (overall ability, visual information processing and visual motor skills) on the VA LV VFQ-48 from baseline to two weeks are the secondary outcome measures.

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:   Yes

Inclusion Criteria:

  1. Primary or secondary open angle glaucoma that has been stable for at least 12 months
  2. Presenting best corrected visual acuity (in the better seeing eye), measured at the screening visit, better than 20/400 but worse than 20/100 as a result of primary or secondary glaucoma.
  3. No surgical or laser procedures in the last 6 months
  4. The minimum number of degrees of central visual field (30-2 or 24-2 SITA threshold) should be no less than 20 degrees

Exclusion Criteria:

  1. Has no access to telephone
  2. Is unable to speak English
  3. Has previously received comprehensive low vision services
  4. Has English literacy screening less than 5th grade level (Dolch Basic Sight Words List)
  5. Has history of stroke with aphasia
  6. Has other health condition that would preclude follow-up (e.g., significant malignancy or life-threatening disease)
  7. Is unable or unwilling to attend clinic visits required for the study
  8. Has severe hearing impairment that interferes with participation in telephone questionnaire
  9. Reports significant loss of vision since last eye exam
  10. Has macular degeneration, vitreous hemorrhage, serous or hemorrhagic detachment of the macula, clinically significant macular edema or cystoid macular edema that is likely to result in further loss or improvement in vision after treatment in better-seeing eye
  11. Planned cataract extraction within the next six months

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 identifier (NCT number): NCT01262209

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Canada, Ontario
Ivey Eye Institute
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: Cindy ML Hutnik, Bsc(Hon), MD, PhD, FRCSC Ivey Eye Institute
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Responsible Party: Cindy Hutnik, Principal Investigator, Lawson Health Research Institute Identifier: NCT01262209    
Other Study ID Numbers: R-10-481
17356 ( Other Identifier: REB )
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Keywords provided by Cindy Hutnik, Lawson Health Research Institute:
Vision loss
Chronic glaucoma
Low vision rehabilitation
Additional relevant MeSH terms:
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Vision, Low
Ocular Hypertension
Eye Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases