Primary Open-angle Glaucoma (POAG) Patient
Conditions
Brief summary
The purpose of this study is to investigate how the intraocular pressure (IOP) varies in time and if the IOP variations are associated with the worsening of glaucoma. IOP patterns will be recorded continuously over 24 hours with SENSIMED Triggerfish® (TF) a portable investigational device using a contact lens sensor. After completing the Triggerfish lens placement and removal; the patient will complete a formal Polysomnography.
Interventions
DEVICESENSIMED Triggerfish®
Sponsors
Sensimed AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Age between 40 and 89 years old * Diagnosis of treated POAG (including normal tension glaucoma (NTG)) * All IOP measurements during the VF period (to be described further) equal or lower than 18 mmHg and/or on average equal or lower than 16 mmHg in the same period * Documented glaucomatous VF damage at baseline, characterized by glaucoma hemifield test result outside normal limits on at least 2 consecutive VF tests or the presence of at least 3 contiguous test points within the same hemifield on the pattern deviation plot at p\<0.01, with at least 1 point at p \< 0.005 * At least 8 visual field tests carried out within at least 2 years, all with fixation losses and false positive/negative results equal or less than 33% * For fast progressing eyes, 1) 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 2) a global rate of VF change based on mean deviation (MD) more negative than -1.0 dB/year * For slowly or minimally progressing eyes a VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression as described above * Not more than 6 diopters spherical equivalent on the study eye * Have given written informed consent, prior to any investigational procedures
Exclusion criteria
* Baseline VF MD more negative than -15 dB. The rationale here is that in severely damaged visual fields, one may not be able to detect and measure rates of progression due to a 'floor effect' * Corneal or conjunctival abnormality precluding contact lens adaptation * Severe dry eye syndrome or other ocular disease * Patients with angle closure glaucoma, traumatic glaucoma or uveitic glaucoma * Patients with previous intraocular surgery in the enrolled eye, including cataract surgery * Patients with allergy to corneal anesthetic * Patients with contraindications for silicone contact lens wear * Patients not able to understand the character and individual consequences of the investigation * Participation in unrelated clinical research within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG. | 24-hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship Between TF Pattern and VF Progression According to TF Slope | 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 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. |
| Relationship Between TF Pattern and VF Progression According to Day and Night | 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. |
| Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak | 24-hour | Number of peaks in 24-Hours TF pattern, defined as the local maximum point in the smoothed TF profile. |
| 24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Slow Progressors 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 | 20 |
| 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 | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Total | Slow Progressors | Fast Progressors |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 8.5 | 65.4 years STANDARD_DEVIATION 8.3 | 68.3 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment United States | 40 participants | 20 participants | 20 participants |
| Sex: Female, Male Female | 27 Participants | 15 Participants | 12 Participants |
| Sex: Female, Male Male | 13 Participants | 5 Participants | 8 Participants |
| Visual field defect | -0.98 dB STANDARD_DEVIATION 1.3 | -0.07 dB STANDARD_DEVIATION 0.12 | -1.88 dB STANDARD_DEVIATION 0.48 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.
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.
Time frame: 24-hour
Population: POAG patients with slow or fast rate of VF glaucoma progression
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast Progressors | Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG. | 410.1 mVeq | Standard Deviation 138.4 |
| Slow Progressors | Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG. | 334.6 mVeq | Standard Deviation 119.4 |
Secondary
24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression
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.
Time frame: 24-hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fast Progressors | 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 |
| Fast Progressors | 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 |
| Fast Progressors | 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 |
| Slow Progressors | 24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression | Systolic blood pressure | -0.19 coefficient of correlation | Standard Deviation 0.32 |
| Slow Progressors | 24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression | Mean arterial blood pressure | -0.21 coefficient of correlation | Standard Deviation 0.28 |
| Slow Progressors | 24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression | Diastolic blood pressure | -0.22 coefficient of correlation | Standard Deviation 0.3 |
Secondary
Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak
Number of peaks in 24-Hours TF pattern, defined as the local maximum point in the smoothed TF profile.
Time frame: 24-hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast Progressors | Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak | 13.1 Number of peaks | Standard Deviation 3 |
| Slow Progressors | Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak | 14.1 Number of peaks | Standard Deviation 4.9 |
p-value: <0.005t-test, 2 sided
Secondary
Relationship Between TF Pattern and VF Progression According to Day and Night
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.
Time frame: 24-hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fast Progressors | Relationship Between TF Pattern and VF Progression According to Day and Night | Diurnal | 84.0 mVeq | Standard Deviation 37.2 |
| Fast Progressors | Relationship Between TF Pattern and VF Progression According to Day and Night | Nocturnal | 30.8 mVeq | Standard Deviation 9.6 |
| Slow Progressors | Relationship Between TF Pattern and VF Progression According to Day and Night | Diurnal | 93.9 mVeq | Standard Deviation 40.6 |
| Slow Progressors | Relationship Between TF Pattern and VF Progression According to Day and Night | Nocturnal | 42.3 mVeq | Standard Deviation 16 |
Secondary
Relationship Between TF Pattern and VF Progression According to TF Slope
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.
Time frame: 24-hour
Population: POAG patients with slow or fast rate of VF glaucoma progression
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fast Progressors | Relationship Between TF Pattern and VF Progression According to TF Slope | Sleep slope | -33.5 mVeq/hour | Standard Deviation 44.6 |
| Fast Progressors | Relationship Between TF Pattern and VF Progression According to TF Slope | Wake slope | 34.9 mVeq/hour | Standard Deviation 55.7 |
| Slow Progressors | Relationship Between TF Pattern and VF Progression According to TF Slope | Sleep slope | -35.7 mVeq/hour | Standard Deviation 61.9 |
| Slow Progressors | Relationship Between TF Pattern and VF Progression According to TF Slope | Wake slope | 34.6 mVeq/hour | Standard Deviation 44.3 |