Babizhayev
MA, Deyev AI, Yermakova VN, Semiletov YA, Davydova
NG, Doroshenko VS, Zhukotskii AV, Goldman IM.
PURPOSE: To
evaluate the effects of 1% N-acetylcarnosine (NAC)
solution on lens clarity over 6 and 24 months
in patients with cataracts. TRIAL DESIGN: Randomised,
placebo-controlled study.
PARTICIPANTS:
49 subjects (76 affected eyes) with an average
age of 65.3 +/- 7.0 years with a diagnosis of
senile cataract with minimum to advanced opacification
in various lens layers. METHODS: 26 patients (41
eyes) were allocated to topical NAC 1% eyedrops
twice daily.
The control group consisted of
13 patients (21 eyes) who received placebo eyedrops
and 10 patients (14 eyes) who did not receive
eyedrops.
MAIN OUTCOME MEASURES:
All patients were evaluated at entry and followed
up every 2 months for a 6-month period (trial
1), or at 6-month intervals for a 2-year period
(trial 2), for best-corrected visual acuity and
glare testing. In addition, cataract was measured
using stereocinematographic slit-images and retro-illumination
examination of the lens. Digital analysis of lens
images displayed light scattering and absorbing
centres in two- and three-dimensional scales.
RESULTS: The
overall intra-reader reproducibility of cataract
measurements (image analysis) was 0.830, and glare
testing 0.998. After 6 months, 90% of NAC-treated
eyes showed improvement in best corrected visual
acuity (7 to 100%) and 88.9% showed a 27 to 100%
improvement in glare sensitivity.
Topographic studies indicated
fewer areas of posterior subcapsular lens opacity
and 41.5% of treated eyes had improvement in image
analysis characteristics. The overall ratios of
image analysis characteristics at 6 months compared
with baseline measures were 1.04 and 0.86 for
the control and NAC-treated group, respectively
(p < 0.001). The apparent benefits of treatment
were sustained after 24 months' treatment.
No treated eyes demonstrated
worsening of vision. The overall visual outcome
in the control group showed significant worsening
after 24 months in comparison with both baseline
and the 6-month follow-up examination. The overall
clinical results observed in the NAC-treated group
by the 24-month period of examination differed
significantly (p < 0.001) from the control
group in the eyes with cortical, posterior subcapsular,
nuclear or combined lens opacities. Tolerability
of NAC eyedrops was good in almost all patients,
with no reports of ocular or systemic adverse
effects.
CONCLUSION:
Topical NAC shows potential for the treatment
and prevention of cataracts.
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