Abstract:

BACKGROUND: After phacoemulsification combined with trabeculectomy in patients with cataract and glaucoma, blood lipid ratio and insulin sensitivity are associated with intraocular pressure, visual acuity and corneal endothelial cells, which may be used for the evaluation of efficacy. Interleukins are the main mediators of the inflammatory response and are involved in the pathogenesis of cataract.

OBJECTIVE: To examine the postoperative changes in interleukin-10, interleukin-2 and interleukin-1β levels in patients with cataract with glaucoma, and to analyze the correlation between insulin sensitivity and corneal endothelial cell density so as to assess whether inflammatory factors can be used to evaluate efficacy.

METHODS: This prospective, single-center, open-label, self-controlled clinical trial will include 160 patients with cataract combined with glaucoma, 35–65 years of age, from the Department of Ophthalmology, First Affiliated Hospital of Kunming Medical University in China. All patients will receive phacoemulsification and trabeculectomy, and will be followed up at 5 days and at 1 and 3 months postoperatively. Data collection and patient recruitment will begin on December 30, 2019 and end on December 30, 2020. Analysis of the results will be performed from May 1, 2021 to May 30, 2021. This study is scheduled to end on June 30, 2021. This study was approved by the Medical Ethics Committee, First Affiliated Hospital of Kunming Medical University, China, on December 15, 2013 (approval No. 20131215085), and will be performed in accordance with the principles of the Declaration of Helsinki, adopted by the World Medical Association. Written informed consent to participate will be obtained from the participants. This study was registered with the Chinese Clinical Trial Registry on September 10, 2019 (registration number: ChiCTR1900025837). Study protocol version is 1.0.

RESULTS AND CONCLUSION: The primary outcome measure will be serum interleukin-2 level, as an index of the inflammatory response, 3 months after surgery. Secondary outcome measures will include serum interleukin-2 level before and 5 days and 1 month after surgery, serum levels of interleukin-1β, interleukin-10, C-reactive protein and tumor necrosis factor-α, best corrected visual acuity, endothelial cell density, mean cell area, coefficient of variation, insulin sensitivity index and intraocular pressure before and 5 days and 1 and 3 months after surgery, and incidence of adverse reactions at 5 days and 1 and 3 months after surgery. From January 2014 to June 2017, our team undertook and completed a small-sample study of 80 cataract patients (95 eyes) with glaucoma. The best corrected visual acuity was significantly improved, endothelial cell density and intraocular pressure were significantly reduced, interleukin-1β, interleukin-2, interleukin-10, C-reactive protein and tumor necrosis factor-α levels were significantly decreased (P < 0.05), and mean cell area, coefficient of variation and insulin sensitivity index were significantly increased (P < 0.05) after phacoemulsification and trabeculectomy. None of the patients had adverse reactions during the treatment. The trial will attempt to explore whether phacoemulsification combined with trabeculectomy has a good therapeutic effect in patients with cataract combined with glaucoma, and clarify whether the effect is associated with the regulation of insulin sensitivity index, corneal endothelial cells and inflammatory factors.

Key words: insulin resistance, cataract, glaucoma, trabeculectomy, phacoemulsification, insulin sensitivity index, corneal endothelial cells, interleukin, C-reactive protein, tumor necrosis factor-α, tissue engineering