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Low recruitment rate
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| Name | Class |
|---|---|
| Yale University | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocular hypertension subjects | Other | All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensimed Triggersfish® (TF) | Device | All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji Liu, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Medical School | New Haven | Connecticut | 06510 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocular Hypertension Non Converters | Stable ocular hypertension patients monitored by Triggerfish (TF) for 24 hours. |
| FG001 | Ocular Hypertension Converters | Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Stable ocular hypertension patients and ocular hypertension patients who progressed to glaucoma, both monitored by TF for 24 hours.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocular Hypertension Non Converters | Stable ocular hypertension patients monitored by TF for 24 hours. |
| BG001 | Ocular Hypertension Converters | Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of participants | 24 hours |
|
Within the 24h recording
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ocular Hypertension Non Converters | Stable ocular hypertension patients monitored by TF for 24 hours. One subject was removed from the analysis because of invalid TF output. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper lid swelling | Eye disorders | Upper lid swelling | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr James Liu | Yale School of Medicine | +1 203 785 2020 | liu.ji@yale.edu |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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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. |
| 24 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Ocular Hypertension Converters | Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | hour | 24 hours |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mVEq | 24 hours |
|
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| 0 |
| 13 |
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Ocular Hypertension Converters | Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours | 0 | 6 | 0 | 6 | 0 | 6 |
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