Collamer intraocular lens: clinical results from the US FDA core study.

PURPOSE: To assess the safety and efficacy of the Staar Collamer intraocular lens (IOL) 1 year postoperatively. SETTING: Fifteen private ophthalmology practices geographically distributed throughout the United States. METHODS: Six hundred eighty-six cases with a mean age of 72.1 years were enrolled in a 2-phase U.S. Food and Drug Administration (FDA) clinical study of the Collamer IOL implanted during phacoemulsification for cataract removal. The 12 month follow-up comprised data from 502 cases. RESULTS: Twelve months postoperatively, 96.2% of all cases and 95.6% without preexisting pathology achieved 20/40 or better best corrected visual acuity. Both results were better than FDA Grid values. No persistent sight-threatening complications, IOL dislocations, or IOL removals were reported. CONCLUSIONS: Results show that the Collamer IOL is safe and effective for use in small incision cataract surgery.

Staar Collamer intraocular lens: clinical results from the phase I FDA core study.

PURPOSE: To assess the early postoperative efficacy and safety of the Staar Collamer intraocular lens (IOL) in small incision cataract surgery. SETTING: Six private ophthalmology practices geographically distributed throughout the United States. METHODS: One hundred twenty-five patients with a mean age of 72.1 years were enrolled in the U.S. Food and Drug Administration (FDA) Phase 1 clinical study of the Staar Collamer IOL after having cataract removal by phacoemulsification. Of these, 107 completed 4 to 6 months of follow-up. RESULTS: At 4 to 6 months postoperatively, 97.1% of patients achieved 20/40 or better corrected visual acuity; 100% of patients without pre-existing pathology (best case) achieved the same result; both results were better than FDA grid values. No persistent sight-threatening complications were reported. Through 6 months, 4.7% of patients required a neodymium:YAG capsulotomy. No IOL dislocations or removals were reported. CONCLUSION: Results indicate that the Collamer material is safe and effective for platehaptic IOLs used in small incision cataract surgery.

The "deroofing" of Schlemm's canal in patients with open-angle glaucoma through placement of a collagen drainage device.

BACKGROUND AND OBJECTIVES: A preliminary study was conducted to examine a new surgical approach for the management of patients with open-angle glaucoma in which Schlemm's canal is opened to restore drainage in a nonpenetrating fashion. The authors compared the results of the surgical procedure including the new glaucoma drainage device with the results of standard trabeculectomy. PATIENTS AND METHODS: The authors performed a new type of surgical procedure on 58 consecutive patients with open-angle glaucoma. The procedure entails "deroofing" Schlemm's canal to facilitate the drainage of aqueous without penetrating the eye. This is done by exposing the canal after a partial-thickness sclerectomy and keratectomy along a 5-mm arc. After the canal was deroofed, a new type of collagen glaucoma drainage device was placed in the surgical site to maintain drainage postoperatively. Patient data, including intraocular pressure (IOP), complications, and the number of medications required to maintain adequate pressures, were analyzed for 1 year postoperatively. RESULTS: Within 1 to 2 months postoperatively, 80.9% of the patients achieved an IOP lower than 21 mm Hg. This improved to 88.9% at 3 to 6 months postoperatively and 87.5% at 6 to 12 months postoperatively. The only major complications were microperforations (8.6%) related to surgical technique and a few cases of high IOP that required repeat operations (10.3%). CONCLUSIONS: The nonpenetrating technique for deroofing the canal effectively allows the drainage of aqueous to acceptable levels (in the range of 15 to 17 mm Hg) without the complications associated with penetrating trabeculectomy. Complications are rare, and the collagen drainage device appears to be effective for allowing the drainage site to remain patent after its dissolution.

Results of secondary anterior chamber intraocular lens implants with iridoplasty and pars plana vitrectomy.

A combined three-part procedure to permit aphakic patients with full iridectomies to receive secondary anterior chamber intraocular lens implants is described. Pars plana vitrectomy leaves the anterior chamber free of vitreous, thus preparing the eye for the iridoplasty and implant. Iridoplasty is performed using a special micro needle that permits good visualization in the eye. The results of ten cases are discussed.