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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04520789
Enrollment
60
Registered
2020-08-20
Start date
2020-09-01
Completion date
2022-12-31
Last updated
2020-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhegmatogenous Retinal Detachment

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.

Interventions

DIAGNOSTIC_TESTRPE cell collection and single cell heterogeneity study

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.

PROCEDUREPostoperative intervention

Early local steroids drug intervention in patients with severe postoperative PVR

PROCEDUREConventional Surgery for Retinal Detachment

Conventional Surgery for Retinal Detachment

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Intraocular pressure (IOP)3 months post operationPatients' IOP(mmHg) assessed by noncontact tonometer
Best Corrected visual Acuity (BCVA)3 months post operationPatients' best corrected visual acuity assessed by logarithmic visual acuity(0.5-1.0; For example, normal vision was 1.0)
Retina reattachment rate3 months post operationPercentage 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)
Number of Severe PVR3 months post operationNumber of participants whose fundus achieved the following conditions simultaneously (B-mode ultrasound showed proliferative band height exceeded 0mm, OCT showed proliferative band exceeded 0um)

Secondary

MeasureTime frameDescription
Intraocular pressure (IOP)12 months post operationPatients' IOP(mmHg) assessed by noncontact tonometer
Retina reattachment rate12 months post operationPercentage 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)
Number of Severe PVR12 months post operationNumber 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)12 months post operationPatients' best corrected visual acuity assessed by logarithmic visual acuity(0.5-1.0; For example, normal vision was 1.0)

Other

MeasureTime frameDescription
RD treatment group1and RD treatment group21 weeks post operation,3 months post operation,12 months post operationProportion (%)of PVR-IC subtypes in RPE cells assessed by 10×Genomics single cell sequencing
RD treatment group22 weeks post operation,3 months post operation,12 months post operationPatients' IOP (mmHg)assessed by noncontact tonometer; len's opacity(Grade1-4) assessed by PENTACAM; number of participants who occurred subconjunctival chemosis and hemorrhage(area 1/4-1)

Contacts

Primary ContactFang Wang, MD,phD
18917683335@163.com+86-18917683335
Backup ContactConghui Zhang, MD,phD
linghui0224@126.com+86-13671886466

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026