Trial Outcomes & Findings for Low Vision Intervention Trial II (LOVIT II) (NCT NCT00958360)
NCT ID: NCT00958360
Last Updated: 2016-08-25
Results Overview
The range of scores for the Visual Reading Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
323 participants
Primary outcome timeframe
changes from baseline to 4 months later
Results posted on
2016-08-25
Participant Flow
A total of 2,051 patients were screened, of whom 1,728 were excluded (1,706 ineligible per chart review and 22 ineligible after screening).
Participant milestones
| Measure |
Interdisciplinary Low Vision Rehabilitation Group
Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
|
Basic Low Vision Care Group
Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
160
|
|
Overall Study
COMPLETED
|
152
|
150
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
Interdisciplinary Low Vision Rehabilitation Group
Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
|
Basic Low Vision Care Group
Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Death
|
6
|
7
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Low Vision Intervention Trial II (LOVIT II)
Baseline characteristics by cohort
| Measure |
Interdisciplinary Low Vision Rehabilitation Group
n=163 Participants
Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
|
Basic Low Vision Care Group
n=160 Participants
Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80.1 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
79.2 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
79.7 years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
158 Participants
n=99 Participants
|
156 Participants
n=107 Participants
|
314 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
157 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
309 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
148 Participants
n=99 Participants
|
144 Participants
n=107 Participants
|
292 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: changes from baseline to 4 months laterThe range of scores for the Visual Reading Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
Outcome measures
| Measure |
Interdisciplinary Low Vision Rehabilitation Group
n=163 Participants
Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
|
Basic Low Vision Care Group
n=160 Participants
Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
|
|---|---|---|
|
Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
|
1.29 logits
Standard Deviation 1.66
|
0.95 logits
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: changes from baseline to 4 months laterThe range of scores for the Mobility subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
Outcome measures
| Measure |
Interdisciplinary Low Vision Rehabilitation Group
n=163 Participants
Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
|
Basic Low Vision Care Group
n=160 Participants
Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
|
|---|---|---|
|
Comparison of Changes in Mobility From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
|
0.31 logits
Standard Deviation 1.15
|
0.12 logits
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: changes from baseline to 4 months laterThe range of scores for the Visual Information Processing subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
Outcome measures
| Measure |
Interdisciplinary Low Vision Rehabilitation Group
n=163 Participants
Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
|
Basic Low Vision Care Group
n=160 Participants
Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
|
|---|---|---|
|
Comparison of Changes in Visual Information Processing From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
|
0.67 logits
Standard Deviation 1.21
|
0.40 logits
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: changes from baseline to 4 months laterThe range of scores for the Visual Motor Skills subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
Outcome measures
| Measure |
Interdisciplinary Low Vision Rehabilitation Group
n=163 Participants
Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
|
Basic Low Vision Care Group
n=160 Participants
Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
|
|---|---|---|
|
Comparison of Changes in Visual Motor Skills From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
|
0.77 logits
Standard Deviation 1.47
|
0.40 logits
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: changes from baseline to 4 months laterThe range of scores for the Overall Visual Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
Outcome measures
| Measure |
Interdisciplinary Low Vision Rehabilitation Group
n=163 Participants
Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
|
Basic Low Vision Care Group
n=160 Participants
Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
|
|---|---|---|
|
Comparison of Overall Visual Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
|
0.70 logits
Standard Deviation 1.06
|
0.43 logits
Standard Deviation 0.89
|
Adverse Events
Interdisciplinary Low Vision Rehabilitation Group
Serious events: 27 serious events
Other events: 10 other events
Deaths: 0 deaths
Basic Low Vision Care Group
Serious events: 29 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interdisciplinary Low Vision Rehabilitation Group
n=163 participants at risk
Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
|
Basic Low Vision Care Group
n=160 participants at risk
Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
|
|---|---|---|
|
General disorders
Non-study related Death
|
4.3%
7/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
5.0%
8/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
Cardiac disorders
Non-study related Prolonged Hospitalization
|
2.5%
4/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
1.2%
2/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
Endocrine disorders
Non-study related Prolonged Hospitalization
|
0.00%
0/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
0.62%
1/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
Eye disorders
Non-study related Prolonged Hospitalization
|
0.00%
0/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
0.62%
1/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
Gastrointestinal disorders
Non-study related Prolonged Hospitalization
|
1.2%
2/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
0.62%
1/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
General disorders
Non-study related Prolonged Hospitalization
|
3.1%
5/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
5.6%
9/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
Injury, poisoning and procedural complications
Non-study related Prolonged Hospitalization
|
0.61%
1/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
1.9%
3/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-study related Prolonged Hospitalization
|
0.00%
0/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
0.62%
1/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
Renal and urinary disorders
Non-study related Prolonged Hospitalization
|
1.2%
2/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
0.00%
0/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
Respiratory, thoracic and mediastinal disorders
Non-study related Prolonged Hospitalization
|
1.8%
3/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
1.2%
2/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
Vascular disorders
Non-study related Prolonged Hospitalization
|
1.8%
3/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
0.62%
1/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
Other adverse events
| Measure |
Interdisciplinary Low Vision Rehabilitation Group
n=163 participants at risk
Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
|
Basic Low Vision Care Group
n=160 participants at risk
Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
|
|---|---|---|
|
Eye disorders
eye hemorrhage
|
1.8%
3/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
0.00%
0/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
Eye disorders
CME
|
4.3%
7/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
0.00%
0/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
|
General disorders
other health reason
|
0.00%
0/163 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
0.62%
1/160 • Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place