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

• Published in: American journal of ophthalmology 2018-09, Vol.193, p.33-44
• Main Authors: Vasavada, Abhay R., Vasavada, Vaishali, Shah, Sajani K., Praveen, M.R., Vasavada, Viraj A., Trivedi, Rupal H., Rawat, Farida, Koul, Archana
• Format: Article
• Language: English
• Subjects: Age; Anesthesia; Cataracts; Clinical trials; Evidence-based medicine; Eye surgery; Glaucoma; Laboratories; Morphology; Ophthalmology; Patients; Pediatrics; Surgeons; Ultrasonic imaging
• ISSN: 0002-9394; 1879-1891
• DOI: 10.1016/j.ajo.2018.06.005

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.