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.