Homonymous HemianopiaNCT00494676
Clinical Trial of Peripheral Prism Glasses for Hemianopia
A study testing High power (57 prism diopter) peripheral prism glasses in people with Homonymous Hemianopia, run by Alexandra Bowers at 13 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homonymous Hemianopia
- What is being tested?
- High power (57 prism diopter) peripheral prism glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2007to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
- Diagnosis of dementia
- Diagnosis of visual neglect
- History of seizures in the last 6 months
- Incomplete hemianopia
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Emory Optical Low Vision
Atlanta, Georgia, 30322
UAB Center for Low Vision Rehabilitation
Birmingham, Alabama, 35294
Indiana University School of Optometry, Low Vision Rehabilitation and Primary Care Services
Bloomington, Indiana, 47404
Schepens Eye Research Institute
Boston, Massachusetts, 02114
Illinois Eye Institute
Chicago, Illinois, 60616
Academy Eye Associates
Durham, North Carolina, 27707
Visual Health@Jupiter Eye Center
Jupiter, Florida, 33458
Vista Center for the Blind and Visually Impaired
Palo Alto, California, 94306
University of Kansas Medical Center
Prairie Village, Kansas, 66208
Vision Care Specialists, P.C.
Southborough, Massachusetts, 01772
NSU Oklahoma College of Optometry,
Tahlequah, Oklahoma, 74464
Seven Lakes Eye Care
West End, North Carolina, 27376
About this study
Official title: Community-based Multi-center Randomized Control Trial of Peripheral Prism Glasses for Hemianopia
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.
Read the 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.
- Conditions
- Homonymous Hemianopia
- Being tested
- High power (57 prism diopter) peripheral prism glasses, Low power sham peripheral prism glasses
- Keywords
- Hemianopia, Mobility, Rehabilitation, Low vision
- Medical subject headings
- Hemianopsia, Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High power (57 prism diopter) peripheral prism glassesDevice
All patients will wear two pairs of prism glasses in a crossover design: the high power peripheral prism glasses and sham peripheral prism glasses. Each pair of prism glasses will be worn for four weeks
Low power sham peripheral prism glassesDevice
Low power (5 prism dioptre) prism glasses that provide only about 2 degrees of visual field expansion.
| Study group | Role | What they receive |
|---|---|---|
| Real prism glasses first, then sham | Experimental | Participants in this arm will receive high power (57 prism diopter) peripheral prism glasses in the first period of the crossover and low power sham peripheral prism glasses in the second period Receives: Device: High power (57 prism diopter) peripheral prism glasses; Device: Low power sham peripheral prism glasses |
| Sham prism glasses first, then real | Experimental | Participants in this arm will receive low power sham peripheral prism glasses in the first period of the crossover and high power (57 prism diopter) peripheral prism glasses in the second period Receives: Device: High power (57 prism diopter) peripheral prism glasses; Device: Low power sham peripheral prism glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Proportion Saying "Yes" to Real 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.
Measured: Evaluated after 4 weeks of wearing each type of prism glasses
Secondary outcomes (3)
Mobility Change Score (All Participants Who Completed Crossover)
Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).
Measured: Evaluated after 4 weeks of wearing each type of prism glasses
Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term)
Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).
Measured: Evaluated after 4 weeks of wearing each type of prism glasses
Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term)
Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility improvement scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).
Measured: Evaluated after 4 weeks of wearing each type of prism glasses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Homonymous HemianopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandra Bowers
- Sponsor type
- University, hospital or other
- Collaborators
- Chadwick Optical Inc., National Eye Institute (NEI)
- Responsible party
- Sponsor-investigator, Alexandra Bowers, Schepens Eye Research Institute
- Investigators
- Alex R Bowers, PhD, Principal investigator, Schepens Eye Research InstituteKaren Keeney, MSBA, Principal investigator, Chadwick Optical Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494676
- Sponsor's protocol ID
- 2006-016
- Other IDs
- R44EY014723
- Status last verified
- Apr 2017
- First submitted
- 28 Jun 2007
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Peli E. Field expansion for homonymous hemianopia by optically induced peripheral exotropia. Optom Vis Sci. 2000 Sep;77(9):453-64. doi: 10.1097/00006324-200009000-00006.
PubMed 11014672Bowers AR, Keeney K, Peli E. Community-based trial of a peripheral prism visual field expansion device for hemianopia. Arch Ophthalmol. 2008 May;126(5):657-64. doi: 10.1001/archopht.126.5.657.
PubMed 18474776Bowers AR, Keeney K, Peli E. Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia. JAMA Ophthalmol. 2014 Feb;132(2):214-22. doi: 10.1001/jamaophthalmol.2013.5636.
PubMed 24201760
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Multi-center Randomized Control Trial of Peripheral Prism Glasses for Hemianopia
- ClinicalTrials.gov ID
- NCT00494676
- Acronym / sponsor ID
- 2006-016
- Conditions
- Homonymous Hemianopia
- Keywords
- Hemianopia, Mobility, Rehabilitation, Low vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Alexandra BowersUniversity, hospital or other
- Collaborators
- Chadwick Optical Inc., National Eye Institute (NEI)
- Study start
- Sep 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Jul 2007 (estimated)
- Results
- Posted 13 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real prism glasses first, then sham | Experimental | Device: High power (57 prism diopter) peripheral prism glasses, Device: Low power sham peripheral prism glassesParticipants in this arm will receive high power (57 prism diopter) peripheral prism glasses in the first period of the crossover and low power sham peripheral prism glasses in the second period |
| Sham prism glasses first, then real | Experimental | Device: High power (57 prism diopter) peripheral prism glasses, Device: Low power sham peripheral prism glassesParticipants in this arm will receive low power sham peripheral prism glasses in the first period of the crossover and high power (57 prism diopter) peripheral prism glasses in the second period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Diagnosis of dementia
- Diagnosis of visual neglect
- History of seizures in the last 6 months
- Incomplete hemianopia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High power (57 prism diopter) peripheral prism glassesAll patients will wear two pairs of prism glasses in a crossover design: the high power peripheral prism glasses and sham peripheral prism glasses. Each pair of prism glasses will be worn for four weeks | Device | Real prism glasses first, then sham, Sham prism glasses first, then real |
| Low power sham peripheral prism glassesLow power (5 prism dioptre) prism glasses that provide only about 2 degrees of visual field expansion. | Device | Real prism glasses first, then sham, Sham prism glasses first, then real |
Primary outcome
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.
3 secondary outcomes
Mobility Change Score (All Participants Who Completed Crossover)
Time frame: Evaluated after 4 weeks of wearing each type of prism glasses
Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term)
Time frame: Evaluated after 4 weeks of wearing each type of prism glasses
Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term)
Time frame: Evaluated after 4 weeks of wearing each type of prism glasses
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11014672Peli E. Field expansion for homonymous hemianopia by optically induced peripheral exotropia. Optom Vis Sci. 2000 Sep;77(9):453-64. doi: 10.1097/00006324-200009000-00006.
- Background: PubMed 18474776Bowers AR, Keeney K, Peli E. Community-based trial of a peripheral prism visual field expansion device for hemianopia. Arch Ophthalmol. 2008 May;126(5):657-64. doi: 10.1001/archopht.126.5.657.
- Derived from this study: PubMed 24201760Bowers AR, Keeney K, Peli E. Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia. JAMA Ophthalmol. 2014 Feb;132(2):214-22. doi: 10.1001/jamaophthalmol.2013.5636.
- Dr Eli Peli's Vision Rehabilitation Lab at Schepens Eye Research InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex R Bowers, PhD principal investigator
Schepens Eye Research Institute
Karen Keeney, MSBA principal investigator
Chadwick Optical Inc.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High power (57 prism diopter) peripheral prism glasses in people with Homonymous Hemianopia, run by Alexandra Bowers at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Proportion Saying "Yes" to Real Prism Glasses (time frame: Evaluated after 4 weeks of wearing each type of prism glasses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00494676, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.