Interim results of the United States investigational device study of the Ophtec capsular tension ring.
Ophthalmology
; 112(3): 460-5, 2005 Mar.
Article
em En
| MEDLINE
| ID: mdl-15745774
ABSTRACT
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 OUTCOMEMEASURES:
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. Neodymiumyttrium-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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Facoemulsificação
/
Implante de Lente Intraocular
/
Cápsula do Cristalino
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2005
Tipo de documento:
Article