NCT04682054

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

December 7, 2020

Last Update Submit

December 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • counts of each cell type

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

    1 month

Study Arms (1)

surgically-removed eye tissue

EXPERIMENTAL
Procedure: ocular surgery

Interventions

surgery to remove the pathological eye tissue

surgically-removed eye tissue

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (4)

  • 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.

    PMID: 33221324BACKGROUND
  • 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.

    PMID: 33161127BACKGROUND
  • 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.

    PMID: 33022222BACKGROUND
  • 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.

    PMID: 32341164BACKGROUND

MeSH Terms

Conditions

Diabetic RetinopathyVitreoretinopathy, ProliferativePterygiumGlaucoma

Interventions

Ophthalmologic Surgical Procedures

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesConjunctival DiseasesOcular Hypertension

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Zizong Hu, PhD, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2020

First Posted

December 23, 2020

Study Start

January 15, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 23, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

The single-cell alts of IPD will be available with reasonable request.

Shared Documents
CSR, ANALYTIC CODE

Locations