Interim results of the United States investigational device study of the Ophtec capsular tension ring.

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.