Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencingvitreoretinopathy

Not Applicable

• Conditions: Rhegmatogenous Retinal Detachment
• Interventions: Procedure: Conventional Surgery for Retinal Detachment; Diagnostic Test: RPE cell collection and single cell heterogeneity study; Procedure: Postoperative intervention

• Registration Number: NCT04520789
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

Study of initiating proliferative vitreoretinopathy (PVR)cell subtype (PVR initiating cells (PVR-IC) in RPE cells of rhegmatogenous retinal detachment (RRD) patients; to prove the percentage of PVR-IC decides the risk of serious PVR occurring after surgery; to investigate the safety and efficacy of early local steroids drug intervention in patients with severe postoperative PVR.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Study First Posted: 2020-08-20
• Last Update Posted: 2020-08-20
• Study Start: 2020-09-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• (1) Age: 18-60 years old, regardless of gender; (2) Clinical diagnosis of with rhegmatogenic retinal detachment (RRD); (3) Surgery for Retinal Detachment is required; (4) Myopia < = 800 degrees; (4) PVR classification: no restrictions; (5) Patients undergoing the first or second operation. (6) Patients volunteered to participate in this study and signed informed consent.

Exclusion Criteria

• (1) Exudative detachment of retina; (2) Those who are allergic to the drugs used in the study; (3) Combined with other eye diseases: other fundus diseases, glaucoma, corneal opacity diseases, genetic diseases); (4) history of internal eye surgery >=3 times; (5) Postoperative follow-up could not be scheduled; (6) Patients with systemic diseases (such as asthma, heart failure, myocardial infarction, liver failure, kidney failure and other major diseases).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RD control group	Conventional Surgery for Retinal Detachment	Conventional Surgery for Retinal Detachment
RD treatment group2	Postoperative intervention	Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study, postoperative intervention
RD treatment group2	RPE cell collection and single cell heterogeneity study	Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study, postoperative intervention
RD treatment group2	Conventional Surgery for Retinal Detachment	Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study, postoperative intervention
RD treatment group1	RPE cell collection and single cell heterogeneity study	Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study
RD treatment group1	Conventional Surgery for Retinal Detachment	Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study

Primary Outcome Measures

Name	Time	Method
Number of Severe PVR	3 months post operation	Number of participants whose fundus achieved the following conditions simultaneously (B-mode ultrasound showed proliferative band height exceeded 0mm, OCT showed proliferative band exceeded 0um)
Best Corrected visual Acuity (BCVA）	3 months post operation	Patients' best corrected visual acuity assessed by logarithmic visual acuity(0.5-1.0； For example, normal vision was 1.0)
Intraocular pressure (IOP)	3 months post operation	Patients' IOP(mmHg) assessed by noncontact tonometer
Retina reattachment rate	3 months post operation	Percentage of participants whose fundus achieved the following conditions simultaneously (B-mode ultrasound showed retinal detachment band height was 0mm, OCT showed subretinal fluid height was 0um)

Secondary Outcome Measures

Name	Time	Method
Retina reattachment rate	12 months post operation	Percentage of participants whose fundus achieved the following conditions simultaneously (B-mode ultrasound showed retinal detachment band height was 0mm, OCT showed subretinal fluid height was 0um)
Best Corrected visual Acuity (BCVA）	12 months post operation	Patients' best corrected visual acuity assessed by logarithmic visual acuity(0.5-1.0； For example, normal vision was 1.0)
Intraocular pressure (IOP)	12 months post operation	Patients' IOP(mmHg) assessed by noncontact tonometer
Number of Severe PVR	12 months post operation	Number of participants whose fundus achieved the following conditions simultaneously (B-mode ultrasound showed proliferative band height exceeded 0mm, OCT showed proliferative band exceeded 0um)