Between February 2002 and September 2004, healthy subjects were enrolled in the study at Shanghai First People’s Hospital. They were recruited from the staff or friends and relatives of the staff, outpatients requiring ametropia correction, and local residents included in an epidemiologic survey for eye fundus diseases. Inclusion criteria were set as: emmetropic refractive error (spherical equivalent between +0.50 and −0.50 D, astigmatism in minus cylinder up to 0.50 D) or low myopia (spherical equivalent up to −5.00 D, astigmatism in minus cylinder up to 1.50 D), age range between 21 and 50 years, clear ocular media or with mild cataract, no abnormal findings in slit lamp and funduscopic examinations, best spectacle corrected visual acuity 6/9 (20/25 or 0.8) or better, no systemic diseases (hypertension, diabetes mellitus), no previous ocular surgery, no ocular morbidity (uveitis, glaucoma, retinitis), and no anisometropia (both eyes are the same). All participants were Chinese. This study was conducted at a site that has no internal review board or ethics committee. However, it did not involve any invasive or irreversible interventions, and informed consent was obtained from all patients in accordance with the tenets of the Declaration of Helsinki.
The size (
n) of the group for comparing could be calculated as follows: Based on former work,
3 the known mean thickness in the white population at the foveola was 178 μm (μ
0), SD was 44 μm (σ), we set α at 0.05 and β at 0.1, then μ
1 = 178 · 0.90 = 160.2,
\[n\ {=}\ \frac{{[}{\sigma}(Z_{1{-}{\alpha}/2}\ {+}\ Z_{1{-}{\beta}/2}){]}^{2}}{({\mu}_{1}\ {-}\ {\mu}_{0})^{2}}\ {=}\ \frac{{[}44(2.81\ {+}\ 1.65){]}^{2}}{(160.2\ {-}\ 178)^{2}}\ {=}\ 121.54\ {\approx}\ 122.\]