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

NCT02030886 | Terminated Results

• 1 other identifier: TF-1302
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (2)

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

  24 hours

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

  24 hours

Study Arms (1)

Ocular hypertension subjects

OTHER

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

Device: Sensimed Triggersfish® (TF)

Interventions

Sensimed Triggersfish® (TF) DEVICE

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

Ocular hypertension subjects

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sensimed AG: lead
• Yale University: collaborator

Study Sites (1)

Yale Medical School

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Dr James Liu
• Organization: Yale School of Medicine

liu.ji@yale.edu

+1 203 785 2020

Study Officials

• Ji Liu, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 9, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 20, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-09

Locations

US (1)