Bendazac lysine in selected types of human senile cataract. A long-term double-masked placebo-controlled clinical trial with multilinear densitometric image analysis of Scheimpflug photographs.
A double-masked placebo-controlled clinical trial with hard data evaluation by image analysis of Scheimpflug photographs taken at baseline and 6, 12 and 18 months after starting treatment was performed to assess the efficacy of bendazac lysine in four different types of senile cataract. The study had a classical split-plot design. For statistical evaluation, the analysis of variance and covariance for repeated measures were used for three different lens sections: anterior capsule and superficial layer, anterior cortex and nucleus. In the entire group of 53 evaluable patients (without separation into cataract-type subgroups), there was a significantly less increase over time in light scattering (i.e. film blackening) of the anterior cortex and nucleus with bendazac lysine than with placebo. There was also a strong trend in favour of the active drug at the anterior capsular level. Patients with water clefts and spokes showed a significantly less light scattering of the anterior capsule and cortex when treated with bendazac lysine. Those with nuclear changes also showed significantly less light scattering of the anterior cortex and nuclear region with the active drug than with placebo. The number of patients with subcapsular and wedge-shaped (cuneiform) cataracts was too small to be adequately assessed by statistical procedures. Nevertheless, there were indications of a beneficial effect of bendazac lysine on all the lens sections in patients with subcapsular cataracts and on the anterior cortical region in those with wedge-shaped cataracts. In conclusion, this study showed that the increase in light scattering over time, i.e. the progression of cataract, is less in bendazac lysine-treated patients than in those treated with placebo.
Hockwin
O
O
Department of Experimental Ophthalmology, University of Bonn, FRG.
Laser
H
H
De Gregorio
M
M
Carrieri
M P
MP
D000328:Adult; D000368:Aged; D002386:Cataract / Q000145:classification / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D003720:Densitometry; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007091:Image Processing, Computer-Assisted; D007191:Indazoles / Q000627:therapeutic use*; D007903:Lens Capsule, Crystalline / Q000032:analysis; D007904:Lens Cortex, Crystalline / Q000032:analysis; D007907:Lens Nucleus, Crystalline / Q000032:analysis; D008297:Male; D008875:Middle Aged; D010781:Photography; D011720:Pyrazoles / Q000627:therapeutic use*; D011897:Random Allocation; D013997:Time Factors
D007191:Indazoles; D011720:Pyrazoles; C036067:bendazac lysine