PURPOSE: To compare the incidence of inflammatory giant-cell deposits (IGCDs) on various foldable intraocular lenses (IOLs) after combined cataract and glaucoma surgery. SETTING: The Phillips Eye Institute, Minneapolis, Minnesota, USA. METHODS: In this prospective randomized clinical trial, 128 patients were randomized to receive a single-piece, first-generation silicone lens (n = 36); a 3-piece acrylic lens (n = 40); or 3-piece, second-generation silicone lens (n = 52). All patients had combined phacoemulsification and trabeculectomy with mitomycin-C by 1 surgeon using a standardized technique. Dilated biomicroscopy was used to identify and quantitate IGCDs on the surface of the IOLs using a 6-point grading scale. RESULTS:Inflammatory giant-cell deposits were identified on 21 of 128 IOLs. Lens design was the most significant risk factor for deposit formation (P =.004). Inflammatory giant-cell deposits were most common in the first-generation silicone plate lens group (33%), less common in the acrylic lens group (15%), and least common in the 3-piece, second-generation silicone group (5.8%). Density of the deposits was significantly greater on the plate lens than the acrylic or the 3-piece silicone lenses (P <.0001). Although IOL design was the most significant risk factor for IGCD formation, other significant risk factors included intraoperative pupil stretch (P =.02) and preoperative miotic use (P =.04). CONCLUSION:Inflammatory giant-cell deposit formation was significantly greater on first-generation silicone plate IOLs than on acrylic or second-generation silicone IOLs. The deposits were somewhat more common on acrylic IOLs than on second-generation silicone IOLs. However, this difference was not clinically or statistically significant.
RCT Entities:
PURPOSE: To compare the incidence of inflammatory giant-cell deposits (IGCDs) on various foldable intraocular lenses (IOLs) after combined cataract and glaucoma surgery. SETTING: The Phillips Eye Institute, Minneapolis, Minnesota, USA. METHODS: In this prospective randomized clinical trial, 128 patients were randomized to receive a single-piece, first-generation silicone lens (n = 36); a 3-piece acrylic lens (n = 40); or 3-piece, second-generation silicone lens (n = 52). All patients had combined phacoemulsification and trabeculectomy with mitomycin-C by 1 surgeon using a standardized technique. Dilated biomicroscopy was used to identify and quantitate IGCDs on the surface of the IOLs using a 6-point grading scale. RESULTS: Inflammatory giant-cell deposits were identified on 21 of 128 IOLs. Lens design was the most significant risk factor for deposit formation (P =.004). Inflammatory giant-cell deposits were most common in the first-generation silicone plate lens group (33%), less common in the acrylic lens group (15%), and least common in the 3-piece, second-generation silicone group (5.8%). Density of the deposits was significantly greater on the plate lens than the acrylic or the 3-piece silicone lenses (P <.0001). Although IOL design was the most significant risk factor for IGCD formation, other significant risk factors included intraoperative pupil stretch (P =.02) and preoperative miotic use (P =.04). CONCLUSION: Inflammatory giant-cell deposit formation was significantly greater on first-generation silicone plate IOLs than on acrylic or second-generation silicone IOLs. The deposits were somewhat more common on acrylic IOLs than on second-generation silicone IOLs. However, this difference was not clinically or statistically significant.