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

Study Overview
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Brief Summary
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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.

Official Title
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Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencing

Conditions
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Rhegmatogenous Retinal Detachment

Intervention / Treatment
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* Diagnostic Test: RPE cell collection and single cell heterogeneity study
* Procedure: Postoperative intervention
* Procedure: Conventional Surgery for Retinal Detachment


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: RD control group<br>Conventional Surgery for Retinal Detachment | Procedure: Conventional Surgery for Retinal Detachment<br>* Conventional Surgery for Retinal Detachment<br>|
| Experimental: RD treatment group1<br>Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study | Diagnostic Test: RPE cell collection and single cell heterogeneity study<br>* Study of initiating proliferative vitreoretinopathy (PVR)cell subtype (PVR initiating cells (PVR-IC) in RPE cells of rhegmatogenous retinal detachment (RRD) patients, the percentage of which decides the risk of serious PVR occurring after surgery.<br>Procedure: Conventional Surgery for Retinal Detachment<br>* Conventional Surgery for Retinal Detachment<br>|
| Active Comparator: RD treatment group2<br>Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study, postoperative intervention | Diagnostic Test: RPE cell collection and single cell heterogeneity study<br>* Study of initiating proliferative vitreoretinopathy (PVR)cell subtype (PVR initiating cells (PVR-IC) in RPE cells of rhegmatogenous retinal detachment (RRD) patients, the percentage of which decides the risk of serious PVR occurring after surgery.<br>Procedure: Postoperative intervention<br>* Early local steroids drug intervention in patients with severe postoperative PVR<br>Procedure: Conventional Surgery for Retinal Detachment<br>* Conventional Surgery for Retinal Detachment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retina reattachment rate | 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) | 3 months post operation | 
| Number of Severe PVR | 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) | 3 months post operation | 
| Best Corrected visual Acuity (BCVA） | Patients' best corrected visual acuity assessed by logarithmic visual acuity(0.5-1.0； For example, normal vision was 1.0) | 3 months post operation | 
| Intraocular pressure (IOP) | Patients' IOP(mmHg) assessed by noncontact tonometer | 3 months post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retina reattachment rate | 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) | 12 months post operation | 
| Number of Severe PVR | 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) | 12 months post operation | 
| Best Corrected visual Acuity (BCVA） | Patients' best corrected visual acuity assessed by logarithmic visual acuity(0.5-1.0； For example, normal vision was 1.0) | 12 months post operation | 
| Intraocular pressure (IOP) | Patients' IOP(mmHg) assessed by noncontact tonometer | 12 months post operation |