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

NCT ID: NCT05386160

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-03-01

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.

Conditions

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Mild Non-proliferative Diabetic Retinopathy Cataract Diabetic Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cataract phacoemulsification combines Ranibizumab

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

Group Type ACTIVE_COMPARATOR

Ranibizumab Injection [Lucentis]

Intervention Type DRUG

intravitreal injection of Ranibizumab;

Cataract phacoemulsification

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

Group Type ACTIVE_COMPARATOR

Ranibizumab Injection [Lucentis]

Intervention Type DRUG

intravitreal injection of Ranibizumab;

Phacoemulsification

Intervention Type DEVICE

Phacoemulsification

Interventions

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Ranibizumab Injection [Lucentis]

intravitreal injection of Ranibizumab;

Intervention Type DRUG

Phacoemulsification

Phacoemulsification

Intervention Type DEVICE

Other Intervention Names

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Phacoemulsification

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zijian Yang, Dr

Role: STUDY_DIRECTOR

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

Locations

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

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zijian Yang, Dr.

Role: CONTACT

+862167888999 ext. 88024

Facility Contacts

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Zijian Yang, Dr.

Role: primary

18121261251

Huiping Yao, Dr.

Role: backup

Other Identifiers

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RuijinH202201

Identifier Type: -

Identifier Source: org_study_id

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