glaucoma increased intraocular pressure
Conditions
Interventions
None listed
Sponsors
Carl Zeiss Meditec, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Normal subjects: 1 Males or females of legal age. 2 Able and willing to make the required study visits. 3 Able and willing to give consent and follow study instructions. 4 Must have a normal visual field in both eyes. ;Glaucoma subjects: 1 Males or females of legal age. 2 Able and willing to make the required study visits. 3 Able and willing to give consent and follow study instructions. 4 Must have glaucoma diagnosis. 5 Must have a glaucomatous visual field abnormality in either eye.
Exclusion criteria
Exclusion criteria: Normal subjects: (Ophthalmic:) 1 Best corrected visual acuity in either eye worse than 20/40 on a Snellen or on a Snellen equivalent acuity chart. 2 Refractive error outside -10.00D to +5.00D range. 3 Glaucoma in either eye. 4 Ocular hypertension (IOP > 22 mm Hg) in either eye. 5 History of ocular hypertension in either eye. 6 Occludable angle with iridolenticular contact or evidence of iridolenticular contact or peripheral anterior synechia. 7 History of angle closure glaucoma in either eye. 8 Presence of disc hemorrhage. 9 Previous cataract surgery in either eye. 10 Previous laser trabeculoplasty in either eye. 11 Previous refractive or vitreoretinal surgery in either eye. 12 Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo-retinal disease in either eye upon dilated examination, or upon evaluation of retinal photos. (Systemic:) 13 History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension, dementia and multiple sclerosis. 14 A life threatening and debilitating disease. 15 Participation in any study involving a non-FDA approved investigational drug (IND) within the past month, or ongoing participation in a study with a non-FDA approved investigational device (IDE). 16 Current or recent (within the past 14 days) use of an agent with photosensitizing properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline, etc.). 17 Concomittant use of hydrochloroquine and chloroquine.;Glaucoma subjects: (Ophthalmic:) 1 Best corrected visual acuity in either eye worse than 20/40 on a Snellen or on a Snellen equivalent acuity chart. 2 Refractive error outside -10.00D to +5.00D range. 3 Secondary glaucomas except pigmentary and pseudoexfoliation glaucoma. 4 Evidence of a VF abnormality which is consistent with a disease other than glaucoma. 5 Previous cataract surgery in the study eye. 6 Previous refractive or vitreoretinal surgery in the study eye. 7 Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo-retinal disease in either eye upon dilated examination or upon evaluation of retinal photos. (Systemic:) 8 History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension, dementia and multiple sclerosis. 9 A life threatening and debilitating disease. 10 Participation in any study involving a non-FDA approved investigational drug (IND) within the past month, or ongoing participation in a study with a non-FDA approved investigational device (IDE). 11 Current or recent (within the past 14 days) use of an agent with photosensitizing properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline, etc.). 12 Concomitant use of hydrochloroquine and chloroquine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Normative limits for GDx parameters (protocol, p 17-18), and Thickness Map. GDx parameters (protocol, p 18) are going to be used to train NFI. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Accuracy of the NFI in classifying glaucoma and non-glaucoma subjects. 2 To compare the GDx RNFL measurements obtained using the ECC method and the standard imaging method (VCC) in normal and glaucoma subjects. 3 To optimize the screening exam protocol and to determine the specificity and the sensitivity of the screening protocol for glaucoma. | — |
Countries
Netherlands
Outcome results
None listed