Clinical Effectiveness of Low Vision Rehabilitation in Glaucoma Patients

NCT01262209 | Completed

• 2 other identifiers: R-10-48117356
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Vision loss; Chronic glaucoma; Low vision rehabilitation

Outcome Measures

Primary Outcomes (1)

• Visual reading ability and visual mobility.

  The primary outcome measure will be visual reading ability and visual mobility.

  2 weeks

Secondary Outcomes (1)

• Other visual ability domains.

  2 weeks

Study Arms (1)

Low Vision Aids

EXPERIMENTAL

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; Device: Telescopes, telemicroscopes and microscopes; Device: Absorptive filters

Interventions

portable CCTV DEVICE

This is a small handheld mini screen intended to improve reading.

Low Vision Aids

Telescopes, telemicroscopes and microscopes DEVICE

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).

Low Vision Aids

Absorptive filters DEVICE

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).

Low Vision Aids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary or secondary open angle glaucoma that has been stable for at least 12 months
• 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.
• No surgical or laser procedures in the last 6 months
• The minimum number of degrees of central visual field (30-2 or 24-2 SITA threshold) should be no less than 20 degrees

You may not qualify if:

• Has no access to telephone
• Is unable to speak English
• Has previously received comprehensive low vision services
• Has English literacy screening less than 5th grade level (Dolch Basic Sight Words List)
• Has history of stroke with aphasia
• Has other health condition that would preclude follow-up (e.g., significant malignancy or life-threatening disease)
• Is unable or unwilling to attend clinic visits required for the study
• Has severe hearing impairment that interferes with participation in telephone questionnaire
• Reports significant loss of vision since last eye exam
• 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
• Planned cataract extraction within the next six months

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Pfizer: collaborator

Study Sites (1)

Ivey Eye Institute

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Glaucoma; Vision Disorders

Interventions

Telescopes

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies

Study Officials

• Cindy ML Hutnik, Bsc(Hon), MD, PhD, FRCSC

  Ivey Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: May 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

CA (1)