The current study seeks to explore the SDOCT potential in a large group of patients in a clinical setting, and to compare it to existing, standard techniques.
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Structural measurements of optic nerve head and surrounding retinal nerve fibre
layer, functional measurements of visual fields, diagnostic accuracy,
measurement reproducibility, progression rates.
Secondary outcome
See protocol.
Background summary
Glaucoma is a leading cause of blindness in the world. Treatment will slow the
disease considerably; in some cases it may even halt disease progression.
Objective measurements to detect the disease early, and to determine any
worsening, currently have their limitations. Spectral Domain Optical Coherence
Tomography (SDOCT) holds a promise to replace all currently existing test
strategies. SDOCT has, however, not been explored on a large scale in a
clinical setting.
Study objective
The current study seeks to explore the SDOCT potential in a large group of
patients in a clinical setting, and to compare it to existing, standard
techniques.
Study design
Observational cross-sectional and longitudinal cohort-study
Study burden and risks
Imaging with commercially available low-luminance ophthalmic camera*s and
scanning devices, functional testing with standard perimetry (usual care),
measurements of intraocular pressure (usual care). Added burden will be 1.5
hours per annum for patients with glaucoma or ocular hypertension and 2 hours
per annum for healthy controls. No risks. Benefits: better detection and
follow-up of glaucoma, and therefore earlier treatment.
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
All 3 groups:
Age >= 18 years and < 85 years.
Informed consent.;Group 1:
Normal VF in both eyes.;Group 2:
Glaucoma diagnosis.
VF defects must be reproducible on at least one occasion.;Group 3:
Ocular hypertension. Untreated IOP on Goldmann applanation tonometry is 24-32 mm Hg. The appearance of the ONH is no selection criterion. There are no significant VF defects.
Exclusion criteria
All 3 groups:
Ophthalmic:
BCVA > 0.3 (LogMAR).
Refractive error ouside -10.0 to +5.0 D range.
Cataract surgery in previous 12 months.
Previous refractive or vitreoretinal surgery.
Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo-retinal disease.
Previous keratoplastic surgery.
Systemic:
Diabetes, leukemia, AIDS, uncontrolled systemic hypertension, multiple sclerosis or life threatening disease.;Group 1:
Glaucoma in either eye.
IOP >= 22 mm Hg in either eye.
Untreated occludable angle with iridolenticular contact or evidence of iridolenticular contact or peripheral anterior synechia.
Presence of disc hemorrhage.;Group 2:
Secondary glaucomas except pigmentary.
Evidence of SAP VF abnormality consistent with other disease. ;Group 3:
Evidence of SAP VF abnormality consistent with other disease.
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 | NL22466.078.08 |