Ocular Hypertension
Conditions
Brief summary
The purpose of the study is to assess the relationship between IOP pattern as recorded over 24 hours by using Triggerfish and quantified by acrophase scored dichotomously, and conversion to glaucoma in OHT patients (conversion status). Elevation of IOP above normal range is called ocular hypertension (OHT). In a previous study, it has been shown that OHT patients who progress to glaucoma (converters) have at baseline and prior to any conversion, IOP patterns that more closely resemble those of established early primary open-angle glaucoma (POAG) patients, while stable OHT patients (non-converters) have IOP patterns closer to those of healthy control subjects. The study has been planned to recruit at least 48 eligible patients (24 converters and 24 non-converters).
Interventions
DEVICESensimed Triggersfish® (TF)
All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours.
Sponsors
Yale University
Sensimed AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of OHT (IOP \>21 mmHg on 2 consecutive visits) in the study eye * No IOP-lowering drug treatment in the study eye; otherwise, a 4-week wash-out period prior to study day 0 (SD0) and throughout the study * Aged ≥ 18 years, of either sex * Not more than 6 diopters spherical equivalent in the study eye * Having given written informed consent, prior to any investigational procedures
Exclusion criteria
* Narrow iridocorneal angle or any other concomitant ocular conditions (except cataract) in the study eye * History of ocular surgery on the study eye (except cataract extraction) * History of laser treatment on the study eye * Corneal or conjunctival abnormality in the study eye, precluding contact lens adaptation * Severe dry eye syndrome * Subjects with irregular sleep schedules * Subjects who are current smokers * Subjects with allergy to corneal anesthetic * Subjects with contraindications for silicone contact lens wear * Subjects not able to understand the character and individual consequences of the investigation * Participation in other clinical research within the last 4 weeks * Any other contra-indication listed in the TF user manual
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status) | 24 hours | For each subject, TF acrophase (ie. time when peak occured) was scored dichotomously (before and after 7 am) and compared between OHT converters and non converters patients. One subject was removed from the analysis because of invalid TF output. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence) | 24 hours | Mean TF acrophase (ie. actual time when peak occured) was compared between OHT converters and non converters. One subject was removed from the analysis because of invalid TF output. |
| Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements | 24 hours | This represents an estimate of the magnitude of 24-hour IOP-related variation. One subject was removed from the analysis because of invalid TF output. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ocular Hypertension Non Converters Stable ocular hypertension patients monitored by TF for 24 hours. | 14 |
| Ocular Hypertension Converters Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours. | 6 |
| Total | 20 |
Baseline characteristics
| Characteristic | Ocular Hypertension Non Converters | Ocular Hypertension Converters | Total |
|---|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 10.9 | 59.3 years STANDARD_DEVIATION 6.7 | 58.7 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 14 participants | 6 participants | 20 participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 6 |
| other Total, other adverse events | 1 / 13 | 0 / 6 |
| serious Total, serious adverse events | 0 / 13 | 0 / 6 |
Outcome results
Primary
Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status)
For each subject, TF acrophase (ie. time when peak occured) was scored dichotomously (before and after 7 am) and compared between OHT converters and non converters patients. One subject was removed from the analysis because of invalid TF output.
Time frame: 24 hours
Population: Stable ocular hypertension patients and ocular hypertension patients who progressed to glaucoma both monitored by TF for 24 hours. One subject was removed from the analysis because of invalid TF output.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocular Hypertension Non Converters | Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status) | Before 7 am | 92.3 percentage of participants |
| Ocular Hypertension Non Converters | Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status) | After 7 am | 7.7 percentage of participants |
| Ocular Hypertension Converters | Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status) | Before 7 am | 66.7 percentage of participants |
| Ocular Hypertension Converters | Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status) | After 7 am | 33.3 percentage of participants |
Secondary
Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence)
Mean TF acrophase (ie. actual time when peak occured) was compared between OHT converters and non converters. One subject was removed from the analysis because of invalid TF output.
Time frame: 24 hours
Population: Stable ocular hypertension patients and ocular hypertension patients who progressed to glaucoma both monitored by TF for 24 hours.~One subject was removed from the analysis because of invalid TF output.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocular Hypertension Non Converters | Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence) | 5.35 hour | Standard Deviation 2.01 |
| Ocular Hypertension Converters | Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence) | 6.30 hour | Standard Deviation 3.55 |
Secondary
Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements
This represents an estimate of the magnitude of 24-hour IOP-related variation. One subject was removed from the analysis because of invalid TF output.
Time frame: 24 hours
Population: Stable ocular hypertension patients and ocular hypertension patients who progressed to glaucoma, both monitored by TF for 24 hours.~One subject was removed from the analysis because of invalid TF output.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocular Hypertension Non Converters | Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements | 126.9 mVEq | Standard Deviation 52.6 |
| Ocular Hypertension Converters | Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements | 128.0 mVEq | Standard Deviation 49.5 |