Five-Year Postoperative Outcomes of Bilateral Aphakia and Pseudophakia in Children up to 2 Years of Age: A Randomized Clinical Trial

Purpose Comparative evaluation of complications and visual outcomes following bilateral congenital cataract surgery in children up to 2 years of age with and without primary intraocular lens (IOL) implantation at 5 years follow-up. Design Randomized controlled clinical trial. Methods Sixty children (120 eyes) up to 2 years of age undergoing bilateral congenital cataract surgery were randomized to Group 1, primary aphakia (n = 30), or Group 2, primary IOL implantation (pseudophakia) (n = 30). A single surgeon performed surgeries with identical surgical technique. All patients were followed up regularly until 5 years postoperatively. At each follow-up, glaucoma, visual axis obscuration (VAO) requiring surgery, and inflammation (cell deposits, posterior synechiae) were assessed. Visual acuity was assessed until 5 years follow-up. The first operated eye was selected for statistical analysis. Results Median age of the patients at time of surgery was 5.11 months (aphakia group) and 6.01 months (pseudophakia group) (P = .56). Five years postoperatively, incidence of glaucoma was 16% and 13.8% in Groups 1 and 2 (P = .82). Incidence of posterior synechiae was significantly higher in the pseudophakia group (27.6%) compared to the aphakia group (8%) (P = .004). VAO requiring surgery was seen in 8% and 10.3% of eyes in Groups 1 and 2 (P = .76). Mean logMAR visual acuity at 5 years follow-up was 0.59 ± 0.33 and 0.5 ± 0.23 in Groups 1 and 2, respectively (P = .79). However, more eyes in the pseudophakic group started giving documentable vision earlier in their postoperative follow-ups. Conclusions Incidence of postoperative complications was comparable between the groups, except for a higher incidence of posterior synechiae in pseudophakic eyes. Visual rehabilitation was faster in the pseudophakic group. Comparative evaluation of complications and visual outcomes following bilateral congenital cataract surgery in children up to 2 years of age with and without primary intraocular lens (IOL) implantation at 5 years follow-up. Randomized controlled clinical trial. Sixty children (120 eyes) up to 2 years of age undergoing bilateral congenital cataract surgery were randomized to Group 1, primary aphakia (n = 30), or Group 2, primary IOL implantation (pseudophakia) (n = 30). A single surgeon performed surgeries with identical surgical technique. All patients were followed up regularly until 5 years postoperatively. At each follow-up, glaucoma, visual axis obscuration (VAO) requiring surgery, and inflammation (cell deposits, posterior synechiae) were assessed. Visual acuity was assessed until 5 years follow-up. The first operated eye was selected for statistical analysis. Median age of the patients at time of surgery was 5.11 months (aphakia group) and 6.01 months (pseudophakia group) (P = .56). Five years postoperatively, incidence of glaucoma was 16% and 13.8% in Groups 1 and 2 (P = .82). Incidence of posterior synechiae was significantly higher in the pseudophakia group (27.6%) compared to the aphakia group (8%) (P = .004). VAO requiring surgery was seen in 8% and 10.3% of eyes in Groups 1 and 2 (P = .76). Mean logMAR visual acuity at 5 years follow-up was 0.59 ± 0.33 and 0.5 ± 0.23 in Groups 1 and 2, respectively (P = .79). However, more eyes in the pseudophakic group started giving documentable vision earlier in their postoperative follow-ups. Incidence of postoperative complications was comparable between the groups, except for a higher incidence of posterior synechiae in pseudophakic eyes. Visual rehabilitation was faster in the pseudophakic group.