Trial Outcomes & Findings for Clinical Trial of Peripheral Prism Glasses for Hemianopia (NCT NCT00494676)
NCT ID: NCT00494676
Last Updated: 2017-04-04
Results Overview
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.
COMPLETED
NA
73 participants
Evaluated after 4 weeks of wearing each type of prism glasses
2017-04-04
Participant Flow
Participants were recruited at 13 study sites, including Dr. Peli's lab at Schepens, 11 vision rehabilitation clinics in the US, and one in the UK. The clinics included university, hospital and private-practice clinics. Each site recruited a median of 7 participants (range 3 to 12). Data were collected in the period October 2007 to January 2010.
97 subjects were screened for eligibility of which 73 met the study criteria and were enrolled. The main reasons for not meeting the inclusion criteria were incomplete hemianopia and spatial neglect.
Participant milestones
| Measure |
Real Prism Glasses Then Sham
Real prism glasses for 4 weeks followed by sham prism glasses for 4 weeks
|
Sham Prism Glasses Then Real
Sham prism glasses for 4 weeks followed by real prism glasses for 4 weeks
|
|---|---|---|
|
Allocation
STARTED
|
37
|
36
|
|
Allocation
COMPLETED
|
35
|
32
|
|
Allocation
NOT COMPLETED
|
2
|
4
|
|
First Intervention
STARTED
|
35
|
32
|
|
First Intervention
COMPLETED
|
34
|
29
|
|
First Intervention
NOT COMPLETED
|
1
|
3
|
|
Second Intervention
STARTED
|
34
|
29
|
|
Second Intervention
COMPLETED
|
33
|
28
|
|
Second Intervention
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Real Prism Glasses Then Sham
Real prism glasses for 4 weeks followed by sham prism glasses for 4 weeks
|
Sham Prism Glasses Then Real
Sham prism glasses for 4 weeks followed by real prism glasses for 4 weeks
|
|---|---|---|
|
Allocation
Withdrawal by Subject
|
2
|
4
|
|
First Intervention
Withdrawal by Subject
|
1
|
3
|
|
Second Intervention
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Clinical Trial of Peripheral Prism Glasses for Hemianopia
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=73 Participants
Includes groups allocated to receive real prism glasses first and sham prism glasses first
|
|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Duration of hemianopia
|
18 Months
n=5 Participants
|
|
Side of hemianopia
Right hemianopia
|
25 Participants
n=5 Participants
|
|
Side of hemianopia
Left hemianopia
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluated after 4 weeks of wearing each type of prism glassesPopulation: Only participants who completed the crossover were included in this analysis
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.
Outcome measures
| Measure |
Entire Study Population
n=61 Participants
Includes groups allocated to receive real prism glasses first and sham prism glasses first
|
|---|---|
|
Overall Proportion Saying "Yes" to Real Prism Glasses
Said yes to real prism glasses
|
39 participants
|
|
Overall Proportion Saying "Yes" to Real Prism Glasses
Said yes to sham prism glasses
|
22 participants
|
SECONDARY outcome
Timeframe: Evaluated after 4 weeks of wearing each type of prism glassesPopulation: Only participants who completed the crossover were included in this analysis
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).
Outcome measures
| Measure |
Entire Study Population
n=61 Participants
Includes groups allocated to receive real prism glasses first and sham prism glasses first
|
|---|---|
|
Mobility Change Score (All Participants Who Completed Crossover)
Mobility change score for real prisms
|
1.9 logits
Standard Deviation 3.3
|
|
Mobility Change Score (All Participants Who Completed Crossover)
Mobility change score for sham prisms
|
1.3 logits
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Evaluated after 4 weeks of wearing each type of prism glassesPopulation: This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and continued to wear prism glasses 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).
Outcome measures
| Measure |
Entire Study Population
n=25 Participants
Includes groups allocated to receive real prism glasses first and sham prism glasses first
|
|---|---|
|
Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term)
Mobility change score for real prisms
|
3.0 logits
Standard Deviation 3.2
|
|
Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term)
Mobility change score for sham prisms
|
1.1 logits
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Evaluated after 4 weeks of wearing each type of prism glassesPopulation: This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and then discontinued wearing prism glasses.
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).
Outcome measures
| Measure |
Entire Study Population
n=35 Participants
Includes groups allocated to receive real prism glasses first and sham prism glasses first
|
|---|---|
|
Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term)
Mobility change score for real prisms
|
1.1 logits
Standard Deviation 3.3
|
|
Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term)
Mobility change score for sham prisms
|
1.6 logits
Standard Deviation 2.7
|
Adverse Events
Entire Study Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place