Clinical trial NCT04520789: Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencingvitreoretinopathy
Official title: Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhegmatogenous Retinal Detachment
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Retina reattachment rate
timeFrame: 3 months post operation
measure: Number of Severe PVR
timeFrame: 3 months post operation
measure: Best Corrected visual Acuity (BCVA）
timeFrame: 3 months post operation
measure: Intraocular pressure (IOP)
timeFrame: 3 months post operation
Secondary outcomes:
measure: Retina reattachment rate
timeFrame: 12 months post operation
measure: Number of Severe PVR
timeFrame: 12 months post operation
measure: Best Corrected visual Acuity (BCVA）
timeFrame: 12 months post operation
measure: Intraocular pressure (IOP)
timeFrame: 12 months post operation
Other outcomes:
measure: RD treatment group1and RD treatment group2
timeFrame: 1 weeks post operation,3 months post operation,12 months post operation
measure: RD treatment group2
timeFrame: 2 weeks post operation,3 months post operation,12 months post operation
Locations:
Study officials:
affiliation: Department of ophthalmology, Shanghai Tenth People's Hospital
name: Fang Wang, MD,phD
role: PRINCIPAL_INVESTIGATOR
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