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

Primary Purpose

Rhegmatogenous Retinal Detachment

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RPE cell collection and single cell heterogeneity study
Postoperative intervention
Conventional Surgery for Retinal Detachment
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rhegmatogenous Retinal Detachment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Sham Comparator

    Experimental

    Active Comparator

    Arm Label

    RD control group

    RD treatment group1

    RD treatment group2

    Arm Description

    Conventional Surgery for Retinal Detachment

    Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study

    Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study, postoperative intervention

    Outcomes

    Primary Outcome Measures

    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)
    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)
    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)
    Intraocular pressure (IOP)
    Patients' IOP(mmHg) assessed by noncontact tonometer

    Secondary Outcome Measures

    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)
    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)
    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)
    Intraocular pressure (IOP)
    Patients' IOP(mmHg) assessed by noncontact tonometer

    Full Information

    First Posted
    August 13, 2020
    Last Updated
    August 19, 2020
    Sponsor
    Shanghai 10th People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04520789
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai 10th People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhegmatogenous Retinal Detachment

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RD control group
    Arm Type
    Sham Comparator
    Arm Description
    Conventional Surgery for Retinal Detachment
    Arm Title
    RD treatment group1
    Arm Type
    Experimental
    Arm Description
    Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study
    Arm Title
    RD treatment group2
    Arm Type
    Active Comparator
    Arm Description
    Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study, postoperative intervention
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    RPE cell collection and single cell heterogeneity study
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Postoperative intervention
    Intervention Description
    Early local steroids drug intervention in patients with severe postoperative PVR
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional Surgery for Retinal Detachment
    Intervention Description
    Conventional Surgery for Retinal Detachment
    Primary Outcome Measure Information:
    Title
    Retina reattachment rate
    Description
    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)
    Time Frame
    3 months post operation
    Title
    Number of Severe PVR
    Description
    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)
    Time Frame
    3 months post operation
    Title
    Best Corrected visual Acuity (BCVA）
    Description
    Patients' best corrected visual acuity assessed by logarithmic visual acuity(0.5-1.0； For example, normal vision was 1.0)
    Time Frame
    3 months post operation
    Title
    Intraocular pressure (IOP)
    Description
    Patients' IOP(mmHg) assessed by noncontact tonometer
    Time Frame
    3 months post operation
    Secondary Outcome Measure Information:
    Title
    Retina reattachment rate
    Description
    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)
    Time Frame
    12 months post operation
    Title
    Number of Severe PVR
    Description
    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)
    Time Frame
    12 months post operation
    Title
    Best Corrected visual Acuity (BCVA）
    Description
    Patients' best corrected visual acuity assessed by logarithmic visual acuity(0.5-1.0； For example, normal vision was 1.0)
    Time Frame
    12 months post operation
    Title
    Intraocular pressure (IOP)
    Description
    Patients' IOP(mmHg) assessed by noncontact tonometer
    Time Frame
    12 months post operation
    Other Pre-specified Outcome Measures:
    Title
    RD treatment group1and RD treatment group2
    Description
    Proportion (%)of PVR-IC subtypes in RPE cells assessed by 10×Genomics single cell sequencing
    Time Frame
    1 weeks post operation,3 months post operation,12 months post operation
    Title
    RD treatment group2
    Description
    Patients' 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)
    Time Frame
    2 weeks post operation,3 months post operation,12 months post operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fang Wang, MD,phD
    Phone
    +86-18917683335
    Email
    18917683335@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Conghui Zhang, MD,phD
    Phone
    +86-13671886466
    Email
    linghui0224@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fang Wang, MD,phD
    Organizational Affiliation
    Department of ophthalmology, Shanghai Tenth People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    To complete the preliminary report of clinical research.evaluation of the clinical protocol.
    IPD Sharing Time Frame
    2022.12- completing follow-up. Summarizing and analyzing all test data.Comparison of efficacy and summary of adverse reactions.Statistical analysis.Overall outcome evaluation of the clinical protocol.
    IPD Sharing Access Criteria
    All access
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