Trial Outcomes & Findings for Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients (NCT NCT01828255)

Results Overview

24-hour measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

24-hour

Results posted on

2020-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Fast Progressors pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p\<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year	Slow Progressors VF MD rate of change more positive than -0.5 dB/year with no significant point defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p\<0.01wise progression
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Slow Progressors n=20 Participants VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield	Fast Progressors n=20 Participants pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p\<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year	Total n=40 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 8.3 • n=5 Participants	68.3 years STANDARD_DEVIATION 8.6 • n=7 Participants	67 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Visual field defect	-0.07 dB STANDARD_DEVIATION 0.12 • n=5 Participants	-1.88 dB STANDARD_DEVIATION 0.48 • n=7 Participants	-0.98 dB STANDARD_DEVIATION 1.3 • n=5 Participants

PRIMARY outcome

Timeframe: 24-hour

Population: POAG patients with slow or fast rate of VF glaucoma progression

24-hour measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.

Outcome measures

Outcome measures
Measure	Fast Progressors n=17 Participants Patients with a fast rate of progression (\<-1dB/y)	Slow Progressors n=17 Participants Patients with a slow rate of progression (\>-1dB/y)
Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.	410.1 mVeq Standard Deviation 138.4	334.6 mVeq Standard Deviation 119.4

SECONDARY outcome

Timeframe: 24-hour

Population: POAG patients with slow or fast rate of VF glaucoma progression

Measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression during wake vs sleep periods. The wake slope corresponds to the change in the TF signal from 1 hour before to 1 hour after the time the subject went to sleep. The sleep slope corresponds to the change from 1 hour before to 1 hour after the time the subject awoke.

Outcome measures

Outcome measures
Measure	Fast Progressors n=17 Participants Patients with a fast rate of progression (\<-1dB/y)	Slow Progressors n=17 Participants Patients with a slow rate of progression (\>-1dB/y)
Relationship Between TF Pattern and VF Progression According to TF Slope Wake slope	34.9 mVeq/hour Standard Deviation 55.7	34.6 mVeq/hour Standard Deviation 44.3
Relationship Between TF Pattern and VF Progression According to TF Slope Sleep slope	-33.5 mVeq/hour Standard Deviation 44.6	-35.7 mVeq/hour Standard Deviation 61.9

SECONDARY outcome

Timeframe: 24-hour

TF measurement during diurnal and nocturnal periods and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.

Outcome measures

Outcome measures
Measure	Fast Progressors n=17 Participants Patients with a fast rate of progression (\<-1dB/y)	Slow Progressors n=17 Participants Patients with a slow rate of progression (\>-1dB/y)
Relationship Between TF Pattern and VF Progression According to Day and Night Diurnal	84.0 mVeq Standard Deviation 37.2	93.9 mVeq Standard Deviation 40.6
Relationship Between TF Pattern and VF Progression According to Day and Night Nocturnal	30.8 mVeq Standard Deviation 9.6	42.3 mVeq Standard Deviation 16.0

SECONDARY outcome

Timeframe: 24-hour

Number of peaks in 24-Hours TF pattern, defined as the local maximum point in the smoothed TF profile.

Outcome measures

Outcome measures
Measure	Fast Progressors n=17 Participants Patients with a fast rate of progression (\<-1dB/y)	Slow Progressors n=17 Participants Patients with a slow rate of progression (\>-1dB/y)
Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak	13.1 Number of peaks Standard Deviation 3.0	14.1 Number of peaks Standard Deviation 4.9

SECONDARY outcome

Timeframe: 24-hour

Comparison (Spearman correlations) between 24-hour IOP-related fluctuations measured by TF and 24-hour blood pressure profiles (systolic, diastolic and mean arterial blood pressure) of POAG patients showing fast and slow rates of glaucoma visual field progression. The correlation between TF and blood pressure measurement was calculated within each subject then mean values were obtained for patients with slow vs fast glaucoma visual field progression.

Outcome measures

Outcome measures
Measure	Fast Progressors n=17 Participants Patients with a fast rate of progression (\<-1dB/y)	Slow Progressors n=17 Participants Patients with a slow rate of progression (\>-1dB/y)
24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression Systolic blood pressure	-0.08 coefficient of correlation Standard Deviation 0.32	-0.19 coefficient of correlation Standard Deviation 0.32
24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression Diastolic blood pressure	-0.06 coefficient of correlation Standard Deviation 0.36	-0.22 coefficient of correlation Standard Deviation 0.30
24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression Mean arterial blood pressure	-0.06 coefficient of correlation Standard Deviation 0.35	-0.21 coefficient of correlation Standard Deviation 0.28

Adverse Events

Fast Progressors

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Slow Progressors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fast Progressors n=20 participants at risk Pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p\<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year	Slow Progressors n=20 participants at risk VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield
Eye disorders Corneal abrasion	5.0% 1/20 • Number of events 1	0.00% 0/20

Additional Information

Dr Gustavo De Moraes

The New York Eye and Ear Infirmary

Phone: +1 212 477 7540

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place