Trial Outcomes & Findings for Variability in Perimetry Study (NCT NCT01051739)
NCT ID: NCT01051739
Last Updated: 2017-03-21
Results Overview
Perimetric method that most efficiently detects visual field change. secondary outcome: number of subjects progressing in each group using pointwise linear regression Linear regression was used to determine visual field worsening (progression) at each of 52 test locations. We required 3 or more worsening test locations at a p = 0.05 significance level for their to be significant progression.
COMPLETED
180 participants
4 years
2017-03-21
Participant Flow
We completed recruitment in the first three years of the grant period at out Visual Field Laboratory at the University of Iowa
see inclusion and exclusion criteria
Participant milestones
| Measure |
Group 1
glaucoma patients
|
Group 2
normal ocular healthy controls
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
60
|
|
Overall Study
COMPLETED
|
92
|
47
|
|
Overall Study
NOT COMPLETED
|
28
|
13
|
Reasons for withdrawal
| Measure |
Group 1
glaucoma patients
|
Group 2
normal ocular healthy controls
|
|---|---|---|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
25
|
10
|
Baseline Characteristics
Variability in Perimetry Study
Baseline characteristics by cohort
| Measure |
Group 1
n=120 Participants
glaucoma with mean deviation from 0 to -25 dB
|
Group 2
n=60 Participants
normal - healthy observers with no eye pathology other than refractive error less than 6 diopters of correction.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
95 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 9 • n=99 Participants
|
61 years
STANDARD_DEVIATION 9 • n=107 Participants
|
64 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
120 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: Those that completed study
Perimetric method that most efficiently detects visual field change. secondary outcome: number of subjects progressing in each group using pointwise linear regression Linear regression was used to determine visual field worsening (progression) at each of 52 test locations. We required 3 or more worsening test locations at a p = 0.05 significance level for their to be significant progression.
Outcome measures
| Measure |
Glaucoma
n=92 Participants
mean deviation 0 to -25 dB
|
Control
n=47 Participants
Age-matched healthy observers were tested at baseline and then every six months for 4 years
|
|---|---|---|
|
Number of Subjects Progressing in Each Group Using Pointwise Linear Regression
|
0 participants
|
0 participants
|
Adverse Events
Group 1
Group 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Wall, M.D.
Iowa City Veterans Administration Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place