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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