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

Stopped early · Not applicable

Conditions studied: Ocular Hypertension

In brief

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).

Key facts

Study ID

NCT02030886

Run by

Sensimed AG

People needed

20

Starts

2013-12-01

Expected to finish

2015-06-01

Last updated by the study team

2020-10-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale Medical School — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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