TF for the Prediction of Visual Field Progression

This is an interventional diagnostic trial for Open Angle Glaucoma Read More

Inclusion Criteria:

1. 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.
2. For glaucoma subjects, MD not worse than -12.00 dB at enrollment in the study eye
3. 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
4. For glaucoma subjects, at least 1 year of experience with VF testing
5. For healthy subjects, normal optic disc, normal VF, IOP ≤ 21 mmHg and open anterior chamber angle in the study eye and no known family history of glaucoma
6. Best corrected visual acuity (BCVA) 20/25 in the study eye at time of screening
7. Aged 22 to 80 years
8. Spherical and cylinder equivalent in the study eye between ±6.00 and ±3.00 diopters, respectively
9. Having given written informed consent, prior to any investigational procedures

Exclusion Criteria:

1. Ocular pathology other than glaucoma in the study eye affecting VF test and OCT-RNFL results
2. Glaucoma surgery in the study eye prior to the screening visit
3. Cataract surgery or glaucoma laser treatment in the study eye within 3 months of the screening visit
4. Subjects with allergy to corneal anesthetic
5. 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
6. 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.
7. Participation in other interventional clinical research within the last 4 weeks