T Kohnen1, R J Lambert, D D Koch. 1. Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA.
Abstract
OBJECTIVE: The purpose of the study is to determine the minimal incision sizes required for implantation of a variety of different foldable intraocular lenses (IOLs) and to evaluate the effect of incision size on tissue damage. DESIGN: Randomized experimental study. PARTICIPANTS: Sixty-nine fresh human cadaveric eyes: 15 (pilot study), 48 (main study), and 6 (scanning electron microscopy study). INTERVENTION: Implantation of foldable IOLs into cadaveric eyes. MAIN OUTCOME MEASURES: In 48 fresh human cadaveric eyes, limbal corneal tunnel incisions were made, and in a randomized fashion, 8 different foldable IOLs of 20.5 diopters (D) were inserted: 4 silicone (SI-30NB, Allergan Medical Optics, Irvine, CA; C10UB, Chiron Ophthalmics, Inc, Irvine, CA; LI41U, IOLAB, Chiron Ophthalmics, Inc, Irvine, CA; AA-4203, Staar Surgical Company, Monrovia, CA); two soft acrylic (MA60BM and MA30BA, both Alcon Laboratories, Inc, Ft. Worth, TX); and two hydrogel models (SH30BC, Alcon; H60M, Storz Ophthalmics, Inc, St. Louis, MO). For each IOL model, six insertions were performed with a recommended implantation device. Using calipers, the authors measured internal and external incision sizes before and after insertion. Scanning electron microscopy was performed on selected incisions in six additional human cadaveric eyes. RESULTS:Incision sizes after insertion ranged from 3.2 to 3.8 mm. The smallest incisions permitting IOL insertion were associated with the injectors. However, these incisions enlarged after insertion by approximately 11% and then were similar to the incision sizes after forceps insertion of the high-refractive-index silicone, the 5.5-mm optic acrylic, and the one-piece hydrogel IOL. The largest incisions were associated with the 6-mm acrylic IOL and the three-piece silicone IOL with a lower refractive index. The scanning electron microscopy showed tearing of corneal tissue after implantation through the smallest incision; this was more pronounced with injectors than with forceps. CONCLUSIONS:Corneal tunnel incisions enlarged up to 11% after insertion of foldable IOLs through the smallest possible incision. With current technology, the smallest postinsertion incision size of a 20.5-D foldable IOL is 3.2 mm.
RCT Entities:
OBJECTIVE: The purpose of the study is to determine the minimal incision sizes required for implantation of a variety of different foldable intraocular lenses (IOLs) and to evaluate the effect of incision size on tissue damage. DESIGN: Randomized experimental study. PARTICIPANTS: Sixty-nine fresh human cadaveric eyes: 15 (pilot study), 48 (main study), and 6 (scanning electron microscopy study). INTERVENTION: Implantation of foldable IOLs into cadaveric eyes. MAIN OUTCOME MEASURES: In 48 fresh human cadaveric eyes, limbal corneal tunnel incisions were made, and in a randomized fashion, 8 different foldable IOLs of 20.5 diopters (D) were inserted: 4 silicone (SI-30NB, Allergan Medical Optics, Irvine, CA; C10UB, Chiron Ophthalmics, Inc, Irvine, CA; LI41U, IOLAB, Chiron Ophthalmics, Inc, Irvine, CA; AA-4203, Staar Surgical Company, Monrovia, CA); two soft acrylic (MA60BM and MA30BA, both Alcon Laboratories, Inc, Ft. Worth, TX); and two hydrogel models (SH30BC, Alcon; H60M, Storz Ophthalmics, Inc, St. Louis, MO). For each IOL model, six insertions were performed with a recommended implantation device. Using calipers, the authors measured internal and external incision sizes before and after insertion. Scanning electron microscopy was performed on selected incisions in six additional human cadaveric eyes. RESULTS: Incision sizes after insertion ranged from 3.2 to 3.8 mm. The smallest incisions permitting IOL insertion were associated with the injectors. However, these incisions enlarged after insertion by approximately 11% and then were similar to the incision sizes after forceps insertion of the high-refractive-index silicone, the 5.5-mm optic acrylic, and the one-piece hydrogel IOL. The largest incisions were associated with the 6-mm acrylic IOL and the three-piece silicone IOL with a lower refractive index. The scanning electron microscopy showed tearing of corneal tissue after implantation through the smallest incision; this was more pronounced with injectors than with forceps. CONCLUSIONS: Corneal tunnel incisions enlarged up to 11% after insertion of foldable IOLs through the smallest possible incision. With current technology, the smallest postinsertion incision size of a 20.5-D foldable IOL is 3.2 mm.