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

Primary Purpose

Ocular Hypertension

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sensimed Triggersfish® (TF)

About this trial

This is an interventional other trial for Ocular Hypertension

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale Medical School

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ocular hypertension subjects

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02030886

First Posted

December 30, 2013

Last Updated

September 28, 2020

Sponsor

Sensimed AG

Collaborators

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT02030886

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment rate

Study Start Date

December 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sensimed AG

Collaborators

Yale University

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ocular Hypertension

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ocular hypertension subjects

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Sensimed Triggersfish® (TF)

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence)

Description

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.

Time Frame

24 hours

Title

Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements

Description

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.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ji Liu, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale Medical School

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

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

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