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Clinical Trial of Peripheral Prism Glasses for Hemianopia
This study is currently recruiting participants.
Verified by Schepens Eye Research Institute, January 2009
Sponsors and Collaborators: Schepens Eye Research Institute
Chadwick Optical Inc.
Information provided by: Schepens Eye Research Institute
ClinicalTrials.gov Identifier: NCT00494676
  Purpose

The purpose of this study is to evaluate the functional utility for general mobility (walking) of new high power permanent peripheral prism glasses, which provide visual field expansion device for patients with homonymous hemianopia (the complete loss of half the field of vision on the same side in both eyes).


Condition Intervention
Homonymous Hemianopia
Device: High power (57 prism diopter) peripheral prism glasses

MedlinePlus related topics: Eye Wear Methamphetamine Rehabilitation
Drug Information available for: Amphetamine Methamphetamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title: Community-Based Multi-Center Randomized Control Trial of Peripheral Prism Glasses for Hemianopia

Further study details as provided by Schepens Eye Research Institute:

Primary Outcome Measures:
  • Clinical success: the proportion of participants fitted with each type of prism glasses for whom the clinical decision is to continue using the glasses (i.e. participants who find the glasses helpful for obstacle avoidance when walking). [ Time Frame: Evaluated after 4 weeks of wearing each type of prism glasses ] [ Designated as safety issue: No ]
  • Rating of how helpful each type of prism glasses are in avoidance of obstacles when walking [ Time Frame: Evaluated after 4 weeks of wearing each type of prism glasses ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ratings of mobility difficulties in various situations without and with each type of prism glasses [ Time Frame: Evaluated at baseline and after 4 weeks of wearing each type of prism glasses ] [ Designated as safety issue: No ]
  • Long-term clinical success: proportion of participants fitted with each type of prism glasses who continue to use and find them helpful for mobility after 6 months [ Time Frame: Evaluated 6 months after the clinical decision to continue with the prism glasses ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All
There are no "arms" as such for this trial. It is a cross-over design; all participants receive both the real prism glasses and the sham prism glasses
Device: High power (57 prism diopter) peripheral prism glasses
All patients will wear two pairs of prism glasses in a cross-over design: the high power peripheral prism glasses and sham peripheral prism glasses. Each pair of prism glasses will be worn for four weeks

Detailed Description:

Patients with hemianopic field loss are unaware of objects in their blind (non-seeing) hemi-field and often experience difficulties with mobility and navigation, such as walking into obstacles on the side of the field loss. In 2000, Peli (2000) described a new peripheral-prism design of prismatic correction for hemianopia, which addresses many of the inadequacies of existing designs of hemianopic visual aids, and produces true field expansion (i.e. the simultaneously seen field is larger with the device than without). In collaboration with the Schepens Eye Research Institute (Boston, MA), Chadwick Optical Inc (White River Junction, VT) has developed a permanent form of Fresnel prism segments, which are made from an acrylic material and can be embedded in a plastic spectacle lens. These permanent prisms offer better cosmesis, optical quality and durability than the temporary 40 prism-diopter press-on Fresnel prism segments used in previous evaluations of the peripheral prism system.

In this study we will evaluate new high-power (57 prism diopter) permanent peripheral prism glasses. Two designs will be evaluated - the "oblique" design and the "horizontal" design. Each design provides expansion in a different area of the visual field. The functional utility of the two designs for general mobility will be assessed.

Each participant will wear both designs of glasses in a cross-over fashion; one pair will contain real prisms and the other pair will contain sham, low power prisms, that provide little field expansion. Real prisms and sham prisms will appear similar. Participants will have either the "oblique" or the "horizontal" design in their real prism glasses and the other design in their sham prism glasses. Prism glasses will be fitted by Low Vision Practitioners at community-based Vision Rehabilitation Clinics.

After wearing the first pair of glasses for 4 weeks, participants will return for an in-office follow up visit, at which a questionnaire will be administered to record their experiences of wearing the glasses. The second pair of prism glasses will then be fitted. Another questionnaire will be administered 4 weeks later to record the experiences of wearing the second set of glasses.

At the end of the period of wearing the second pair of prism glasses, a clinical decision will be made as to whether the participant should continue to use the prism glasses (e.g. if a participant finds the prism glasses helpful for obstacle avoidance when walking). For participants who continue with the prism glasses, a final telephone follow-up interview will be conducted after about 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age.
  • Sighted in both eyes, with monocular visual acuity (best corrected vision), of at least 20/50 in each eye.
  • Complete homonymous hemianopia of more than 3 months duration
  • Refractive error within the -5D to +5D range
  • No significant cognitive impairment
  • No history of wearing the Peli system of peripheral prisms for hemianopic field expansion (patients who have worn another type of prismatic correction for hemianopia such as yoked prisms or the Gottlieb VAS system can participate in the study)
  • No physical or mental disabilities, including cognitive dysfunction, balance problems or other deficits that could impair ability to walk or use the peripheral prism spectacles.
  • Able to walk (using a cane or walker is OK) or control the movements of their own wheelchair.
  • In sufficiently good health to attend four in-office visits.

Exclusion Criteria:

  • Diagnosis of dementia
  • Diagnosis of visual neglect
  • History of seizures in the last 6 months
  • Incomplete hemianopia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494676

Contacts
Contact: Alex R Bowers, PhD 617-912-2512 alex.bowers@schepens.harvard.edu

Locations
United States, Alabama
UAB Center for Low Vision Rehabilitation Recruiting
Birmingham, Alabama, United States, 35294
United States, California
Vista Center for the Blind and Visually Impaired Completed
Palo Alto, California, United States, 94306
United States, Florida
Visual Health@Jupiter Eye Center Recruiting
Jupiter, Florida, United States, 33458
United States, Georgia
Emory Optical Low Vision Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Illinois Eye Institute Recruiting
Chicago, Illinois, United States, 60616
United States, Indiana
Indiana University School of Optometry, Low Vision Rehabilitation and Primary Care Services Recruiting
Bloomington, Indiana, United States, 47404
United States, Kansas
University of Kansas Medical Center Recruiting
Prairie Village, Kansas, United States, 66208
United States, Massachusetts
Vision Care Specialists, P.C. Recruiting
Southborough, Massachusetts, United States, 01772
Schepens Eye Research Institute Recruiting
Boston, Massachusetts, United States, 02114
United States, North Carolina
Seven Lakes Eye Care Recruiting
West End, North Carolina, United States, 27376
Academy Eye Associates Recruiting
Durham, North Carolina, United States, 27707
United States, Ohio
United Disability Services / Low Vision Withdrawn
Akron, Ohio, United States, 44311
United States, Oklahoma
NSU Oklahoma College of Optometry, Recruiting
Tahlequah, Oklahoma, United States, 74464
United Kingdom
Manchester Royal Eye Hospital Recruiting
Manchester, United Kingdom, M60 1QD
Sponsors and Collaborators
Schepens Eye Research Institute
Chadwick Optical Inc.
Investigators
Principal Investigator: Alex R Bowers, PhD Schepens Eye Research Institute
Principal Investigator: Karen Keeney, MSBA Chadwick Optical Inc.
  More Information

Dr Eli Peli's Vision Rehabilitation Lab at Schepens Eye Research Institute  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Schepens Eye Research Institute ( Alex Bowers )
Study ID Numbers: 2006-016, R44 - EY014723
Study First Received: June 28, 2007
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00494676  
Health Authority: United States: Institutional Review Board

Keywords provided by Schepens Eye Research Institute:
Hemianopia
Mobility
Rehabilitation
Low vision

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Methamphetamine
Dopamine
Vision Disorders
Eye Diseases
Neurologic Manifestations
Amphetamine
Blindness
Hemianopsia
Vision, Low

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Sympathomimetics
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Stimulants
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009