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Clinical Trials/NCT00494676
NCT00494676CompletedNot Applicable

Community-based Multi-center Randomized Control Trial of Peripheral Prism Glasses for Hemianopia

Alexandra Bowers26 sites in 2 countries73 target enrollmentStarted: September 1, 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
73
Locations
26
Primary Endpoint
Overall Proportion Saying "Yes" to Real Prism Glasses

Study Overview

Brief Summary

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). The efficacy of real peripheral prism glasses will be assessed relative to sham peripheral prism glasses.

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. The study will employ a crossover design in which each participant will wear a pair of real prism glasses (high-power, 57 prism diopter) and a pair sham prism glasses (low-power, 5 prism diopters, that provide little field expansion) in counterbalanced order. The efficacy of the real prism glasses relative to the sham prism glasses will be assessed for general mobility (walking). We expect that participants will prefer the real prism glasses over the sham prism glasses as the former will be more helpful for obstacle detection when walking.

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 real 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 -5 dioptre to +5 dioptre 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

Outcomes

Primary Outcomes

Overall Proportion Saying "Yes" to Real Prism Glasses

Time Frame: Evaluated after 4 weeks of wearing each type of prism glasses

At the end of each crossover period, participants were asked a yes/no question: "If the study were to end today, would you want to continue with these prism glasses (i.e. the prism glasses worn in that period)?" The primary outcome was the overall difference, across the two periods of the crossover, between the proportion of participants saying "yes" to real prism glasses and the proportion saying "yes" to sham prism glasses.

Secondary Outcomes

  • Mobility Change Score (All Participants Who Completed Crossover)(Evaluated after 4 weeks of wearing each type of prism glasses)
  • Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term)(Evaluated after 4 weeks of wearing each type of prism glasses)
  • Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term)(Evaluated after 4 weeks of wearing each type of prism glasses)

Investigators

Sponsor
Alexandra Bowers
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Alexandra Bowers

Principal Investigator

Schepens Eye Research Institute

Study Sites (26)

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