The Anatomic and Functional Outcomes of Ozurdex-Aided Vitrectomy in Proliferative Diabetic Retinopathy

Abstract

Purpose: To investigate the 3-months outcomes of patients who underwent intraoperative intravitreal injection of Ozurdex for proliferative diabetic retinopathy (PDR).

Methods: This is a prospective randomized controlled clinical trial (ChiCTR2100043399). Seventy-one patients with PDR who had indications for surgery without intravitreal injection history within 3 months preoperatively were enrolled. Patients were randomly divided into three groups based on the medicine injected intraoperatively: Ozurdex, Conbercept, and Control group. The primary outcome is the best-corrected visual acuity (BCVA) within 3 months postoperatively. The secondary outcomes include the intraocular pressure (IOP), mean sensitivity, central retinal thickness and vessels perfusion.

Results: The BCVA and the mean sensitivity improved in the three groups (F = 130.8, P < 0.0001; F = 34.18, P < 0.0001), but there was no statistical difference among the three groups (F = 0.858, P = 0.552; F = 0.964, P = 0.452). The IOP was no significant differences among the three groups within 3 months postoperatively (F = 0.881, P = 0.533). Compared with the other two groups, central retinal thickness (CRT) and outer retinal layer (ORL) thickness decreased significantly in patients of the Ozurdex group (F = 3.037, P = 0.008; F = 2.626, P = 0.018), especially in the diabetic macular edema (DME) patients (F = 2.761, P = 0.0164; F = 2.572, P = 0.0240). In macular region, superficial vascular plexus (SVP), intermediate capillary plexus (ICP) and deep capillary plexus (DCP) perfusion were not shown statistical difference at 3 months postoperatively in the all three groups compared with 1 day postoperatively (P > 0.05).

Conclusion: Compared with the other two groups, anatomical outcomes was improved significantly in Ozurdex group for DR patients. Ozurdex may help to improve the visual acuity and visual sensitivity, and there is no significant difference in the change of IOP and microvascular improvement.

Clinical trial registration: This trial is registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn, registration number ChiCTR2100043399).

Keywords: microperimetry; optical coherence tomography angiography; ozurdex; pars plana vitrectomy; proliferative diabetic retinopathy.

Figure 1

(A) Mean change of BCVA in patients from baseline to 3 months postoperatively. (B) Mean change of microperimetry mean sensitivity in patients from 1 day to 3 months postoperatively. (C) Mean change of CRT in patients from 1 day to 3 months postoperatively. (D) Mean change of ORL thickness in patients from 1 day to 3 months postoperatively. (E) Mean change of CCP in patients from 1 day to 3 months postoperatively. (✳Ozurdex, ^#Conbercept, ^##Control, *^##Ozurdex-Control, ^###Conbercept-Control).

Figure 2

(A) Mean change of BCVA in patients with DME from baseline to 3 months postoperatively. (B) Mean change of microperimetry mean sensitivity in patients with DME from 1 day to 3 months postoperatively. (C) Mean change of CRT in patients with DME from 1 day to 3 months postoperatively. (D) Mean change of ORL thickness in patients with DME from 1 day to 3 months postoperatively. (✳Ozurdex, ^#Conbercept, ^##Control,*^##Ozurdex-Control).

Figure 3

(A) Mean change of BCVA in patients without DME from baseline to 3 months postoperatively. (B) Mean change of microperimetry mean sensitivity in patients without DME from 1 day to 3 months postoperatively. (C) Mean change of GCC thickness in patients without from 1 day to 3 months postoperatively. (D) Mean change of the RNFL thickness in patients without DME from 1 day to 3 months postoperatively. (E) Mean change of CCP in patients without DME from 1 day to 3 months postoperatively. (✳Ozurdex, ^#Conbercept, ^##Control, *^##Ozurdex-Control, ^###Conbercept-Control).

Figure 4

(A) Retinal thickness stratification diagram. (B–D) Retinal vessels perfusion stratification diagram: from left to right, SVP, ICP, DCP. (E–P) Postoperative SS-OCT scans of patients with PDR undergoing vitrectomy plus intraoperative injection of Ozurdex or Conbercept.