PURPOSE: To determine the foreign-body response to three intraocular lens (IOL) biomaterials (poly[methyl methacrylate] [PMMA], silicone, and AcrySof) and use this as an indicator of their comparative biocompatibility postoperatively within the eye. SETTING:A British teaching hospital eye department. METHODS:Ninety eyes were prospectively randomized to receive a PMMA, silicone, or AcrySof IOL. All lenses had 6.0 mm optics with PMMA haptics. A standardized surgical protocol was performed by a single surgeon using an extracapsular technique with capsulorhexis; eyes that experienced a surgical complication were excluded. All patients had standardized postoperative medication and follow-up. Specular microscopy of the anterior IOL surface was carried out after pupil dilation on days 1, 7, 30, 90, 180, 360, and 720 to assess small cell and giant cell reactions. RESULTS: All three IOL types produced a mild degree of nonspecific foreign-body response, which resolved over the study period without detrimental effect. The silicone group had significantly higher small cell counts than the PMMA and AcrySof groups (P = .02); the AcrySof group had significantly lower giant cell counts than the other two groups (P = .003). CONCLUSION: The three IOL types were sufficiently biocompatible to function in normal eyes with age-related cataracts. However, AcrySof IOLs were associated with lower giant cell counts than PMMA and silicone IOLs and might produce better results in eyes with pre-existing blood-aqueous barrier damage.
RCT Entities:
PURPOSE: To determine the foreign-body response to three intraocular lens (IOL) biomaterials (poly[methyl methacrylate] [PMMA], silicone, and AcrySof) and use this as an indicator of their comparative biocompatibility postoperatively within the eye. SETTING: A British teaching hospital eye department. METHODS: Ninety eyes were prospectively randomized to receive a PMMA, silicone, or AcrySof IOL. All lenses had 6.0 mm optics with PMMA haptics. A standardized surgical protocol was performed by a single surgeon using an extracapsular technique with capsulorhexis; eyes that experienced a surgical complication were excluded. All patients had standardized postoperative medication and follow-up. Specular microscopy of the anterior IOL surface was carried out after pupil dilation on days 1, 7, 30, 90, 180, 360, and 720 to assess small cell and giant cell reactions. RESULTS: All three IOL types produced a mild degree of nonspecific foreign-body response, which resolved over the study period without detrimental effect. The silicone group had significantly higher small cell counts than the PMMA and AcrySof groups (P = .02); the AcrySof group had significantly lower giant cell counts than the other two groups (P = .003). CONCLUSION: The three IOL types were sufficiently biocompatible to function in normal eyes with age-related cataracts. However, AcrySof IOLs were associated with lower giant cell counts than PMMA and silicone IOLs and might produce better results in eyes with pre-existing blood-aqueous barrier damage.
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