IOP Patterns in Ocular Hypertensive Patients Newly Converted to Glaucoma vs Stable Ocular Hypertensive Patients

Not Applicable

Terminated

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ocular hypertension subjects	Sensimed Triggersfish® (TF)	All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.