MedPath

Spectral Domain Optical Coherence Tomography for Glaucoma Diagnostics

Completed
Conditions
10018307
glaucoma
ocular hypertension
Registration Number
NL-OMON39104
Lead Sponsor
Oogziekenhuis Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
600
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.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Structural measurements of optic nerve head and surrounding retinal nerve fibre<br /><br>layer, functional measurements of visual fields, diagnostic accuracy,<br /><br>measurement reproducibility, progression rates.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>See protocol.</p><br>
© Copyright 2025. All Rights Reserved by MedPath