PURPOSE: To compare the centration and fixation of silicone plate-haptic intraocular lenses (IOLs) with different-sized positioning holes. SETTING:Eye Clinic of the Johannes Gutenberg-University Mainz, Mainz, Germany. METHODS: In a prospective randomized study, 51 Chiroflex C10 and 56 Chiroflex C11 IOLs were implanted under standardized conditions by the same surgeon. The IOL position was documented at the end of surgery and by retroillumination on the first day and 5 months postoperatively. The positioning-hole area was evaluated by ultrasound biomicroscopy (50 MHz) 5 months postoperatively. RESULTS: One day postoperatively, no IOL in either group was decentered more than 1.0 mm. After 5 months, 33% of the C10 and 42% of the C11 IOLs were decentered between 0.5 and 1.0 mm, and 11% of the C10 and 8% of the C11 IOLs were decentered more than 1.0 mm (maximum 1.23 mm and 1.41 mm, respectively). Up to the first postoperative day, 20% of the C10 and 22% of the C11 lenses were rotated more than 15 degrees. At 5 months, an additional 15% of the C10 and 19% of the C11 lenses were rotated. Ultrasound biomicroscopy showed no tissue or capsule adhesion in the holes in most cases (85% C10 group; 71% C11 group). No difference was statistically significant. CONCLUSIONS: Larger positioning holes did not prevent IOL decentration or rotation; thus, this IOL design appears unsuitable for correcting astigmatism. Because tissue in the positioning hole was rare with both lens types, it is doubtful that enlarged plate-haptic perforations will prevent IOL luxation into the vitreous cavity after capsulotomy.
RCT Entities:
PURPOSE: To compare the centration and fixation of silicone plate-haptic intraocular lenses (IOLs) with different-sized positioning holes. SETTING: Eye Clinic of the Johannes Gutenberg-University Mainz, Mainz, Germany. METHODS: In a prospective randomized study, 51 Chiroflex C10 and 56 Chiroflex C11 IOLs were implanted under standardized conditions by the same surgeon. The IOL position was documented at the end of surgery and by retroillumination on the first day and 5 months postoperatively. The positioning-hole area was evaluated by ultrasound biomicroscopy (50 MHz) 5 months postoperatively. RESULTS: One day postoperatively, no IOL in either group was decentered more than 1.0 mm. After 5 months, 33% of the C10 and 42% of the C11 IOLs were decentered between 0.5 and 1.0 mm, and 11% of the C10 and 8% of the C11 IOLs were decentered more than 1.0 mm (maximum 1.23 mm and 1.41 mm, respectively). Up to the first postoperative day, 20% of the C10 and 22% of the C11 lenses were rotated more than 15 degrees. At 5 months, an additional 15% of the C10 and 19% of the C11 lenses were rotated. Ultrasound biomicroscopy showed no tissue or capsule adhesion in the holes in most cases (85% C10 group; 71% C11 group). No difference was statistically significant. CONCLUSIONS: Larger positioning holes did not prevent IOL decentration or rotation; thus, this IOL design appears unsuitable for correcting astigmatism. Because tissue in the positioning hole was rare with both lens types, it is doubtful that enlarged plate-haptic perforations will prevent IOL luxation into the vitreous cavity after capsulotomy.