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Status unknownNCT04682054EyesinglecellUpdated Dec 23, 2020

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

An interventional study of ocular surgery in Diabetic Retinopathy, Proliferative Vitreoretinopathy and Pterygium, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-12-23.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Diabetic Retinopathy
  • Proliferative Vitreoretinopathy
  • Pterygium
  • Glaucoma
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In context

Diabetic Retinopathy

778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.

This study's planned enrollment of 80 is close to the median of 80 across 481 interventional studies indexed under Diabetic Retinopathy.

Browse Diabetic Retinopathy studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.

Browse The First Affiliated Hospital with Nanjing Medical University studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    surgically-removed eye tissue

    Procedure: ocular surgery

Interventions

  • Procedureocular surgery

    surgery to remove the pathological eye tissue

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What researchers measure

Primary outcomes

  1. counts of each cell type

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

    Time frame: 1 month

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Study locations

1 site
  • First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210029, China
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References and documents

Publications

  • 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. PubMed 33221324 ↗
  • 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. PubMed 33161127 ↗
  • 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. PubMed 33022222 ↗
  • 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. PubMed 32341164 ↗

Individual participant data

Plan to share: Yes — The single-cell alts of IPD will be available with reasonable request.

Supporting information: Clinical study report, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04682054
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Dec 23, 2020
Start date
Jan 15, 2021 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Dec 23, 2020

Study contacts

Zizong Hu, PhD, MD
Contact
huzizhong@njum.edu.cn
+8615195960100

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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