TF for the Prediction of Visual Field Progression

NCT03047239 | Withdrawn

• 1 other identifier: TF-1701
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Baseline 24-hour SENSIMED Triggerfish (TF) recordings as well as functional and structural vision tests measured prospectively every 3 months over a 2-year period, will be used to model TF's ability to serve as a risk factor for individual progression rates.

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Diagnostic odds ratio (DOR) for a SENSIMED Triggerfish based model for the prediction of visual field annual progression rate (24-2 SITA Standard) measured as Mean Deviation (MD) slope

  2 years

Study Arms (1)

Open angle glaucoma

EXPERIMENTAL

SENSIMED Triggerfish

Device: SENSIMED Triggerfish

Interventions

SENSIMED Triggerfish DEVICE

Smart contact lens based device indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours

Open angle glaucoma

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For glaucoma subjects, a clinical diagnosis of OAG\* in the study eye with an abnormal optic disc defined as:
• diffuse or focal narrowing, or notching, of the optic disc rim, or
• progressive narrowing of the neuroretinal rim with an associated increase in cupping of the optic disc increased cupping of the optic disc, or
• diffuse or localized abnormalities of the parapapillary RNFL, or
• disc rim, parapapillary RNFL, or lamina cribrosa hemorrhages, or
• optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue, or
• large extent of parapapillary atrophy and an abnormal VF defined as
• VF damage consistent with RNFL damage (e.g., nasal step, arcuate field defect, or paracentral depression in clusters of test sites) based on the presence of a cluster of 3 or more non-edge points on the pattern deviation plot at p \< 5% with 1 point at p \< 1%, or
• Glaucoma Hemifield Test (GHT) outside normal limits.
• OAG\*:
• Primary open angle glaucoma (POAG; includes normal tension glaucoma (NTG), i.e.: POAG with all known untreated IOP measurements \< 22 mmHg using Goldmann applanation tonometry): defined by the presence of open angles on gonioscopy in the absence of other causes of glaucomatous optic neuropathy and VF defects; or
• Exfoliative glaucoma (XFG): defined by the presence of exfoliative material on the pupil border and/or on the surface of the lens capsule except the central zone; or
• Pigmentary glaucoma (PEG): defined by the presence of pigment dispersed on the trabecular meshwork, Schwalbe's line, the iris surface, the lens equator, the corneal endothelium, and/or characteristic trans-illumination defects of the mid-peripheral iris.
• For glaucoma subjects, MD not worse than -12.00 dB at enrollment in the study eye
• For glaucoma subjects, no IOP-lowering treatment or stable IOP-lowering treatment regimen in the study eye in the 3 months prior to the screening visit

You may not qualify if:

• Ocular pathology other than glaucoma in the study eye affecting VF test and OCT-RNFL results
• Glaucoma surgery in the study eye prior to the screening visit
• Cataract surgery or glaucoma laser treatment in the study eye within 3 months of the screening visit
• Subjects with allergy to corneal anesthetic
• Subjects with contraindications for TF wear: active eye disease, eye injury or eye abnormality affecting the cornea, conjunctiva, or eyelids, subject history of eye or eyelid infections including styes or history of AEs associated with wearing contact lenses, or intolerance, or abnormal ocular response to contact lenses, active inflammation of the eye, active infection of the eye, corneal vascularization, insufficiency of lacrimal secretion, corneal hypoesthesia, known allergy to silicone
• Subjects unable or unwilling to comply with the study procedures and who are unlikely to be able to complete the 24-month follow-up period.
• Participation in other interventional clinical research within the last 4 weeks

Sponsors & Collaborators

• Sensimed AG: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 8, 2017
• Study Start: June 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share