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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Mild Non-proliferative Diabetic Retinopathy, Cataract Diabetic, Diabetic Retinopathy

Intervention / Treatment
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* Drug: Ranibizumab Injection [Lucentis]
* Device: Phacoemulsification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cataract phacoemulsification combines Ranibizumab<br>0.05 ml of ranibizumab was injected into the vitreous immediately after the operation | Drug: Ranibizumab Injection [Lucentis]<br>* intravitreal injection of Ranibizumab；<br>* Other names: Phacoemulsification;|
| Active Comparator: Cataract phacoemulsification<br>0.05 ml of ranibizumab was injected into the vitreous immediately after the operation | Drug: Ranibizumab Injection [Lucentis]<br>* intravitreal injection of Ranibizumab；<br>* Other names: Phacoemulsification;Device: Phacoemulsification<br>* Phacoemulsification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| capillary non-perfusion zone of non-proliferative diabetic retinopathy | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of inflammatory factors in anterior aqueous humor | 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. | before cataract phacoemulsification | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phaco, VEGF, diabetic retinopathy