AcrySof phakic angle-supported intraocular lens for the correction of moderate-to-high myopia: one-year results of a multicenter European study.
OBJECTIVE
To investigate the safety and effectiveness of the AcrySof phakic angle-supported intraocular lens (IOL) (Alcon Laboratories, Inc., Fort Worth, TX) for correction of moderate-to-high myopia in adults.


METHODS
One-year interim analysis of a phase 3, nonrandomized, open-label, prospective, multicenter European clinical study.


METHODS
A total of 190 subjects (190 eyes) with moderate-to-high myopia. The preoperative mean manifest refraction spherical equivalent (MRSE) was -10.38 diopters (D) +/-2.43 standard deviation (SD).


METHODS
Unilateral implantation of the AcrySof phakic angle-supported IOL.


METHODS
Best spectacle-corrected visual acuity (BSCVA), uncorrected distance visual acuity (UCVA), predictability and stability of MRSE, adverse events, and endothelial cell density.


RESULTS
Of 190 subjects enrolled, 161 completed the 1-year postoperative visit. No subjects lost > or =2 lines BSCVA. A UCVA of 20/20 or better was achieved by 57.8%; 99.4% had 20/40 or better. A BSCVA of 20/32 or better was achieved by 100% of subjects; 85.7% had 20/20 or better. The mean MRSE was -0.23 D (+/-0.50 D: -2.50 to 0.75 D). Residual refractive error was within +/-1.0 D from the target for 95.7% of subjects and within +/-0.5 D for 72.7% of subjects. The overall mean percentage change in central endothelial cell density 1 year after surgery was -4.77+/-8.04% (n = 139). No pupil ovalization, pupillary block, or retinal detachment events were observed.


CONCLUSIONS
The AcrySof phakic angle-supported IOL yielded excellent refractive correction and predictability with acceptable safety in subjects with moderate-to-high myopia. These 1-year interim analysis findings demonstrate preliminary support for the safety and efficacy of this IOL.
Kohnen
Thomas
T
Johann Wolfgang Goethe-University, Department of Ophthalmology, Frankfurt/Main, Germany. kohnen@em.unifrankfurt.de
Knorz
Michael C
MC
Cochener
Béatrice
B
Gerl
Ralf H
RH
Arné
Jean-Louis
JL
Colin
Joseph
J
Alió
Jorge L
JL
Bellucci
Roberto
R
Marinho
Antonio
A
D000180:Acrylic Resins; D000293:Adolescent; D000328:Adult; D000869:Anterior Eye Segment / Q000601:surgery*; D002452:Cell Count; D004728:Endothelium, Corneal / Q000473:pathology; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019654:Lens Implantation, Intraocular / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000601:surgery*; D054120:Phakic Intraocular Lenses; D011183:Postoperative Complications; D011446:Prospective Studies; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
D000180:Acrylic Resins