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.

• Recruitment status: COMPLETED
• Target enrollment: 180 participants
• Primary outcome timeframe: 4 years
• Results posted on: 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=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants	41 Participants n=4 Participants	66 Participants n=27 Participants
Age, Categorical >=65 years	95 Participants n=93 Participants	19 Participants n=4 Participants	114 Participants n=27 Participants
Age, Continuous	68 years STANDARD_DEVIATION 9 • n=93 Participants	61 years STANDARD_DEVIATION 9 • n=4 Participants	64 years STANDARD_DEVIATION 9 • n=27 Participants
Sex: Female, Male Female	73 Participants n=93 Participants	43 Participants n=4 Participants	116 Participants n=27 Participants
Sex: Female, Male Male	47 Participants n=93 Participants	17 Participants n=4 Participants	64 Participants n=27 Participants
Region of Enrollment United States	120 Participants n=93 Participants	60 Participants n=4 Participants	180 Participants n=27 Participants

PRIMARY outcome

Timeframe: 4 years

Population: 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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 319-3380581

Email: michael-wall@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place