Phacoemulsification Combined With Intravitreal Injection of Ranibizumab Prevent Postoperative Capillary Non-perfusion Zone Progress in Non-proliferative Diabetic Retinopathy

Last updated: May 18, 2022
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetic Retinopathy

Eye Disorders/infections

Eye Disease

Treatment

N/A

Clinical Study ID

NCT05386160
RuijinH202201
  • Ages 18-90
  • All Genders

Study Summary

Diabetic retinopathy has been found progress in 20-70% diabetic patient after cataract phacoemulsification surgery. Intravitreal injection of anti-VEGF Ranibizumab is an important treatment for diabetic retinopathy including non-proliferative diabetic retinopathy (NPDR). However, there is no research about phacoemulsification surgery combine Intravitreal injection of Ranibizumab on diabetic retinopathy. The research focus on the effect of phacoemulsification surgery combine intravitreal injection of Ranibizumab on mild non-proliferative diabetic retinopathy and explore the reasons for differences in treatment outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed and dated informed consent
  • Commitment to follow the research procedures and cooperate with the implementation ofthe whole process of research
  • No specific gender, 18+ years old
  • Diagnosed in line with NPDR,
  • Phacoemulsification combined with anti-VEGF therapy is planned
  • No obvious surgical contraindications

Exclusion

Exclusion Criteria:

  • Use of other investigational drug treatments or take part in other types of clinicalstudies
  • Allergy to anti-VEGF drugs
  • Patients with other macular and optic disc diseases
  • Patients with meaningful diabetic macular edema
  • Patient with surgical complications

Study Design

Total Participants: 96
Study Start date:
July 01, 2022
Estimated Completion Date:
March 01, 2023

Study Description

This research is a single-center prospective, randomized controlled study. Patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of Ranibizumab group. Eye examination including visual acuity, intraocular pressure(IOP), fundus fluoroscopy, macular optical coherence tomograph（OCT） examination, were taken before cataract surgery. The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group, and 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation. The aqueous humor concentrations of vascular endothelial growth factor（VEGF）, interleukin（IL）IL-2, IL-4, and Tumor Necrosis Factor（TNF） were checked by real-time polymerase chain reaction assay（RT-PCR） and ELISA analysis. The Best Corrected Visual Acuity（BCVA）, IOP and fundus lesions changes were observed in the two groups after operation. Diabetic retinopathy capillary non-perfusion zone were evaluated one year after phacoemulsification surgery.

Connect with a study center

  • Department of Ophthalmology, Ruijin Hospital Affiliated Medical,Shanghai Jiaotong University School

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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