Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00494676
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2007-06-28
Brief Title:
Clinical Trial of Peripheral Prism Glasses for Hemianopia
Sponsor:
Alexandra Bowers
Organization:
Massachusetts Eye and Ear Infirmary
Study Overview
Official Title:
Community-based Multi-center Randomized Control Trial of Peripheral Prism Glasses for Hemianopia
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44EY014723 | NIH | None | httpsreporternihgovquickSearchR44EY014723 |