Ophthalmology · 2005
Interim results of the United States investigational device study of the Ophtec capsular tension ring.
Клиническое исследованиеКлиническое исследование III фазыСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Price Francis W, Mackool Richard J, Miller Kevin M, Koch Paul, Oetting Thomas A, Johnson A Tim
Аннотация
PURPOSE: To evaluate the safety and efficacy of the Ophtec capsular tension ring (CTR) in providing capsular support during and/or after cataract extraction in cases of a weak or partially broken ciliary zonule.
DESIGN: Phase III multicenter, nonrandomized, investigational device study.
PARTICIPANTS: Twelve investigators at 9 sites enrolled 224 subjects and placed 255 CTRs.
METHODS: Capsular tension rings were placed in patients who were found to have a weakened or partially broken ciliary zonule comprising <34% of the circumference of the lens capsule. Two CTR models were evaluated, with noncompressed diameters of 12 mm and 13 mm. Patients were examined preoperatively, intraoperatively, and postoperatively at day 1 and months 1, 3, 6, and 12.
MAIN OUTCOME MEASURES: Rate of successful stabilization of the capsular bag and intraocular lens (IOL) centration, complications, and adverse events.
RESULTS: Interim results from this ongoing study indicate that immediately after surgery 98.8% of IOLs were centered and 1.2% of the IOLs implanted (3/251) were not centered. Subsequently, the prevalence of decentered IOLs was 1.7% (4/236) 3 months after surgery, 3.8% (8/211) 6 months after surgery, and 2.3% (4/172) 12 months after surgery. The primary complication was posterior capsular opacification, which is unlikely to be a complication of CTR insertion. Neodymium:yttrium-aluminum-garnet laser capsulotomies have been performed in 12.8% of eyes by 12 months (22/172).
CONCLUSIONS: Ophtec CTR models 275 and 276 safely provided capsular support during and after cataract surgery in cases where the zonule was weak or partially broken.
DESIGN: Phase III multicenter, nonrandomized, investigational device study.
PARTICIPANTS: Twelve investigators at 9 sites enrolled 224 subjects and placed 255 CTRs.
METHODS: Capsular tension rings were placed in patients who were found to have a weakened or partially broken ciliary zonule comprising <34% of the circumference of the lens capsule. Two CTR models were evaluated, with noncompressed diameters of 12 mm and 13 mm. Patients were examined preoperatively, intraoperatively, and postoperatively at day 1 and months 1, 3, 6, and 12.
MAIN OUTCOME MEASURES: Rate of successful stabilization of the capsular bag and intraocular lens (IOL) centration, complications, and adverse events.
RESULTS: Interim results from this ongoing study indicate that immediately after surgery 98.8% of IOLs were centered and 1.2% of the IOLs implanted (3/251) were not centered. Subsequently, the prevalence of decentered IOLs was 1.7% (4/236) 3 months after surgery, 3.8% (8/211) 6 months after surgery, and 2.3% (4/172) 12 months after surgery. The primary complication was posterior capsular opacification, which is unlikely to be a complication of CTR insertion. Neodymium:yttrium-aluminum-garnet laser capsulotomies have been performed in 12.8% of eyes by 12 months (22/172).
CONCLUSIONS: Ophtec CTR models 275 and 276 safely provided capsular support during and after cataract surgery in cases where the zonule was weak or partially broken.