Abstract
Purpose: To compare the performance of nylon sutures to that of polyglactin sutures in pediatric patients undergoing cataract surgery.Setting: University of Campinas (UNICAMP), Campinas, São Paulo, BrazilDesign: A prospective, randomized, partially masked, single-site clinical trial. (https://clinicaltrials.gov/ct2/show/NCT03812640).Methods: A total of 80 eyes from 80 patients who underwent pediatric cataract surgery were randomized into two groups in block sizes of four. Group A consisted of 41 patients whose surgical incisions were sutured with polyglactin 10-0 material. Group B consisted of 39 patients whose surgical incisions were sutured with nylon 10-0 material. The primary outcome was frequency of suture-related complications in each group. Secondary outcomes were the frequency with which suture removal was necessary.Results: The incidence of suture-related complications within 6 months of follow up was 0 out of 41 eyes (0.00%) in the polyglactin group and 17 out of 39 eyes (43.59%) in the nylon control group (p < 0.001). In all of the eyes with suture-related complications, the sutures were promptly removed. The most frequent complications were vascularization near the suture (17.95%) and loose sutures (17.95%). No ocular or systemic study-related adverse events were observed.Conclusions: Polyglactin sutures were found to be safe and effective for pediatric patients undergoing cataract surgery. Their lower rate of complications and reduced likelihood of removal (and the subsequent need for general anesthesia) make their use preferrable to that of nylon sutures. This study represents the first controlled randomized clinical trial to compare nylon sutures to polyglactin sutures in pediatric patients undergoing cataract surgery.Clinical Trial Registration: URL: https://clinicaltrials.gov/ct2/show/, Identifier: NCT03812640.
Highlights
Though rare, pediatric cataracts are a major cause of childhood blindness
Group A consisted of 41 patients whose surgical incisions were sutured with polyglactin 10-0 material
Group B consisted of 39 patients whose surgical incisions were sutured with nylon 10-0 material
Summary
Pediatric cataracts are a major cause of childhood blindness. Children deprived of adequate treatment experience worsened quality of life, and the socioeconomic costs are higher overall. Pediatric cataracts generate ∼200,000 cases of blindness in children around the world each year as a result of unoperated cataracts, surgical complications, or consequences of diseases such as glaucoma and amblyopia [1,2,3,4]. Children’s sclera exhibits limited rigidity, resulting in poor integrity of the surgical incision if no sutures are made. This situation requires surgeons to systematically suture the surgical incision in order to guarantee the perfect closure of the eyeball and prevent complications such as leakage of the aqueous humor with postoperative hypotonia, iris prolapse, or anterior synechiae formation, as well as to prevent intraocular infection caused by the entrance of microorganisms into the incision. Due to the need for nylon suture removal, other materials are being considered
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