Stratus OCT User Manual PN 2660021134133 A
Normative Database for Macula and RNFL Measurements
C-1
(C) Normative Database for Macula
and RNFL Measurements
Introduction
The Stratus OCT normative database study was designed to obtain normative data for
macular and RNFL thickness from healthy subjects ages 18 to 86. Six centers participated
in the prospective, non-comparative study. Enrolled subjects were representative of healthy
individuals with no history of eye disease and were carefully screened and evaluated for
eligibility. Generally, subjects presented to the clinical center for routine refraction analysis.
Medical and ophthalmic histories were taken prior to enrolling the subject in the study.
Subjects who had a history of diabetes, glaucoma, or ocular surgery (other than cataract or
refractive surgery more than 1 year ago) were disqualified from the study.
Selection Criteria
Subjects were given a complete ophthalmic examination (unless the subject was seen at
the clinic for a regular eye examination within the last 60 days); it included the following
tests:
A. Distance visual acuity using the Humphrey 24-2 SITA Standard threshold test,
bilaterally. Any defects found were verified with a second test.
B. Goldmann applanation tonometry.
C. Axial length measurement using an IOLMaster.
D. Slit lamp examination of the anterior segment of both eyes.
E. Dilated ophthalmoscopic examination, bilaterally.
F. Fundus photography of the maculas and the optic nerves of both eyes.
If the various ophthalmic examinations showed any abnormalities, the subject was
disqualified from the study. Excluded from the study were individuals with the following
characteristics:
A. Contraindications to dilation (including occludable anterior chamber angles), or
intolerance or hypersensitivity to topical anesthetics or mydriatics in either eye.
B. Ocular hypertension (IOP = 22 mm Hg in either eye) or glaucoma in either eye.
C. Evidence of reproducible visual field abnormality in either eye, defined as PSD
significant at p < 5% level, or abnormal Glaucoma Hemifield test result, or any
other pattern of loss which is consistent with ocular disease. The test must be
To Next Page
Loading...
