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Molecular Taxonomy of Surgically-harvested Ocular Tissues Defined by Single-cell Transcriptomics (Eyesinglecell)

Primary Purpose

Diabetic Retinopathy, Proliferative Vitreoretinopathy, Pterygium

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ocular surgery
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with ocular diseases and require surgery intervention.
  2. The surgery intervention remove pathological tissue during surgery.
  3. Patients consent to the treatment and single-cell sequencing.

Exclusion Criteria:

1. Surgically removed eye tissue cannot meet with the quality control of single-cell sequencing (mainly the tissue weight and cell counts);

Sites / Locations

  • First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

surgically-removed eye tissue

Arm Description

Outcomes

Primary Outcome Measures

counts of each cell type
single-cell sequencing identify what cells and the counts within the eye tissue

Secondary Outcome Measures

Full Information

First Posted
December 7, 2020
Last Updated
December 20, 2020
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04682054
Brief Title
Molecular Taxonomy of Surgically-harvested Ocular Tissues Defined by Single-cell Transcriptomics
Acronym
Eyesinglecell
Official Title
Molecular Taxonomy of Surgically-harvested Ocular Tissues Defined by Single-cell Transcriptomics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The surgically-harvested eye tissue (ie. vitreous-retinal proliferative membrane, outflow pathway, retinas, and pterygium) is a complex tissue responsible for maintaining intraocular homeostasis or mediating ocular pathogenesis. Dysfunction of one or more resident cell types within the tissues results in different ocular disorder, leading to vision loss, or even blindness. In this study, we aim to use single-cell RNA sequencing to generate a comprehensive cell atlas of surgically-harvested eye tissues.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Proliferative Vitreoretinopathy, Pterygium, Glaucoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgically-removed eye tissue
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
ocular surgery
Intervention Description
surgery to remove the pathological eye tissue
Primary Outcome Measure Information:
Title
counts of each cell type
Description
single-cell sequencing identify what cells and the counts within the eye tissue
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ocular diseases and require surgery intervention. The surgery intervention remove pathological tissue during surgery. Patients consent to the treatment and single-cell sequencing. Exclusion Criteria: 1. Surgically removed eye tissue cannot meet with the quality control of single-cell sequencing (mainly the tissue weight and cell counts);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zizong Hu, PhD, MD
Phone
+8615195960100
Email
huzizhong@njum.edu.cn
Facility Information:
Facility Name
First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zizhong Hu, Dr
Phone
15195960100
Email
huzizhong@njmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The single-cell alts of IPD will be available with reasonable request.
Citations:
PubMed Identifier
33221324
Citation
Tan WJ, Wang MM, Castagnoli PR, Tang T, Chan ASY, Lim TS. Single B-Cell Genomic Analyses Differentiate Vitreoretinal Lymphoma from Chronic Inflammation. Ophthalmology. 2021 Jul;128(7):1079-1090. doi: 10.1016/j.ophtha.2020.11.018. Epub 2020 Nov 20.
Results Reference
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PubMed Identifier
33161127
Citation
Wynne N, Carroll J, Duncan JL. Promises and pitfalls of evaluating photoreceptor-based retinal disease with adaptive optics scanning light ophthalmoscopy (AOSLO). Prog Retin Eye Res. 2021 Jul;83:100920. doi: 10.1016/j.preteyeres.2020.100920. Epub 2020 Nov 6.
Results Reference
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PubMed Identifier
33022222
Citation
de Bruijn SE, Fiorentino A, Ottaviani D, Fanucchi S, Melo US, Corral-Serrano JC, Mulders T, Georgiou M, Rivolta C, Pontikos N, Arno G, Roberts L, Greenberg J, Albert S, Gilissen C, Aben M, Rebello G, Mead S, Raymond FL, Corominas J, Smith CEL, Kremer H, Downes S, Black GC, Webster AR, Inglehearn CF, van den Born LI, Koenekoop RK, Michaelides M, Ramesar RS, Hoyng CB, Mundlos S, Mhlanga MM, Cremers FPM, Cheetham ME, Roosing S, Hardcastle AJ. Structural Variants Create New Topological-Associated Domains and Ectopic Retinal Enhancer-Gene Contact in Dominant Retinitis Pigmentosa. Am J Hum Genet. 2020 Nov 5;107(5):802-814. doi: 10.1016/j.ajhg.2020.09.002. Epub 2020 Oct 5.
Results Reference
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PubMed Identifier
32341164
Citation
van Zyl T, Yan W, McAdams A, Peng YR, Shekhar K, Regev A, Juric D, Sanes JR. Cell atlas of aqueous humor outflow pathways in eyes of humans and four model species provides insight into glaucoma pathogenesis. Proc Natl Acad Sci U S A. 2020 May 12;117(19):10339-10349. doi: 10.1073/pnas.2001250117. Epub 2020 Apr 27.
Results Reference
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Molecular Taxonomy of Surgically-harvested Ocular Tissues Defined by Single-cell Transcriptomics

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