To obtain clinical data from normal individuals to establish significance limits for the GDx RNFL measurements using the ECC method and to collect GDx RNFL measurements in subjects with early, moderate and advanced glaucoma using the ECC method to…
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
An objective method to assess the retinal nerve fiber layer (RNFL) is through
scanning laser polarimetry (SLP). To improve the ability of SLP to detect small
changes at low retardance, a new enhanced imaging method, enhanced corneal
compensation (ECC), with improved signal/noise ratio has been developed for
RNFL measurements with GDx. This method employs modified software used during
imaging but is otherwise identical to the original hardware.
Study objective
To obtain clinical data from normal individuals to establish significance
limits for the GDx RNFL measurements using the ECC method and to collect GDx
RNFL measurements in subjects with early, moderate and advanced glaucoma using
the ECC method to train a machine learning classifier, the Nerve Fiber
Indicator (NFI).
Study design
This is an open-label, prospective, multicenter study. After undergoing a
general ophthalmic examination, qualifying subjects will undergo scans of their
retinal nerve fiber layers with the GDx. This study is designed in a way to
support a longitudinal data collection if the PIs or the Study Sponsor decide
to reconsent the same subjects for further longitudinal data collection.
Study burden and risks
For the purpose of this study, normal and glaucoma subjects are required.
Burden is considered to be limited, risk is similar to that of a full eye
examination in a doctor's office. Participants do not benefit from this study
(45 Euro excepted).
5160 Hacienda Drive
Dublin, CA 94568
USA
5160 Hacienda Drive
Dublin, CA 94568
USA
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13416.078.06 |