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

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05386160

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mild Non-proliferative Diabetic Retinopathy Cataract Diabetic Diabetic Retinopathy	Drug: Ranibizumab Injection [Lucentis] Device: Phacoemulsification	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cataract phacoemulsification combines Ranibizumab 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation	Drug: Ranibizumab Injection [Lucentis] intravitreal injection of Ranibizumab； Other Names: Phacoemulsification
Active Comparator: Cataract phacoemulsification 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation	Drug: Ranibizumab Injection [Lucentis] intravitreal injection of Ranibizumab； Other Names: Phacoemulsification Device: Phacoemulsification Phacoemulsification

Arm

Intervention/Treatment

Active Comparator: Cataract phacoemulsification combines Ranibizumab

0.05 ml of ranibizumab was injected into the vitreous immediately after the operation

Drug: Ranibizumab Injection [Lucentis]

intravitreal injection of Ranibizumab；

Other Names:

Phacoemulsification

Active Comparator: Cataract phacoemulsification

0.05 ml of ranibizumab was injected into the vitreous immediately after the operation

Drug: Ranibizumab Injection [Lucentis]

intravitreal injection of Ranibizumab；

Other Names:

Phacoemulsification

Device: Phacoemulsification

Phacoemulsification

Outcome Measures

Primary Outcome Measures

capillary non-perfusion zone of non-proliferative diabetic retinopathy [1 year]
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 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 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.

Secondary Outcome Measures

Determination of inflammatory factors in anterior aqueous humor [before cataract phacoemulsification]
The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group. The aqueous humor concentrations of VEGF, IL-2, IL-4, and TNF were checked by RT-PCR and ELISA analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed and dated informed consent
Commitment to follow the research procedures and cooperate with the implementation of the 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 Criteria:

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