NL-OMON30646CompletedNot Applicable
Collection of Normative and Glaucoma Data Using GDx VCC Scanning Laser Polarimetry - Normative and Glaucoma Data Using GDx VCC
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Carl Zeiss Meditec, Inc.
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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.
Investigators
Similar Trials
Completed
Not Applicable
Advanced glaucoma studyGlaucomaJPRN-UMIN000001004Japan Glaucoma Society200
Not yet recruiting
Not Applicable
Early Detection of Glaucoma(Human Eye Disease) using Intraocular pressure (IOP), Fundus and Optical coherence tomography (OCT) images of patientCTRI/2018/07/014902Kasturba Medical College and Hospital
Completed
Not Applicable
Data collection in Non-diseased Eyes with Long Axial Length and Development of Software using RS-3000Healthy individualsJPRN-UMIN000004377Kyoto University Graduate School of Medicine288
Completed
Not Applicable
Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the EyeOcular PhysiologyNCT01663688Nidek Co. LTD.279
Recruiting
Not Applicable
Disease registry of glaucoma patientsGlaucomaJPRN-UMIN000037627Tohoku University Hospital3,000