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

NCT ID: NCT02030886

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-06-30

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).

Conditions

Ocular Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ocular hypertension subjects

All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours.

Group Type: OTHER

Sensimed Triggersfish® (TF)

Intervention Type: DEVICE

All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours.

Interventions

Sensimed Triggersfish® (TF)

All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Sensimed AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ji Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Medical School

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

TF-1302

Identifier Type: -

Identifier Source: org_study_id