IOP Patterns in Ocular Hypertensive Patients Newly Converted to Glaucoma vs Stable Ocular Hypertensive Patients
| Status: | Terminated |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/21/2016 |
| Start Date: | December 2013 |
| End Date: | June 2015 |
A Single-center, Open Label, Prospective Study Assessing the 24-hour IOP Patterns Using SENSIMED Triggerfish® in Ocular Hypertensive Patients Newly Converted to Glaucomatous Disease Versus Stable Ocular Hypertensive Patients
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).
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).
Inclusion Criteria:
- Diagnosis of OHT (IOP >21mmHg 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 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
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