Evidence map›Paper›PMID 32019699›Full record

Trial reportOphthalmology2020

Beyond Performance Metrics: Automatic Deep Learning Retinal OCT Analysis Reproduces Clinical Trial Outcome.

Jessica Loo, Traci E Clemons, Emily Y Chew, Martin Friedlander, Glenn J Jaffe, Sina Farsiu

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01949324 (A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
3.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01949324 phase2completednot on this map

A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)

TypeinterventionalSponsorNeurotech PharmaceuticalsRan2014 to 2017Enrolled67ConditionsMacular Telangiectasia Type 2ArmsCiliary neurotrophic factor (CNTF), Sham procedure, NT-501 Implant, NT-501 Implant procedure
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 34 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 1 country.

Jessica LooDepartment of Biomedical Engineering, Duke University, Durham, North Carolina.
Traci E ClemonsOphthalmology, Emmes, Rockville, Maryland.
Emily Y ChewDivision of Epidemiology and Clinical Applications, National Eye Institute, Bethesda, Maryland.
Martin FriedlanderDepartment of Molecular Medicine, The Scripps Research Institute, La Jolla, California; The Lowy Medical Research Institute, La Jolla, California.
Glenn J JaffeDepartment of Ophthalmology, Duke University Medical Center, Durham, North Carolina.
Sina FarsiuDepartment of Biomedical Engineering, Duke University, Durham, North Carolina; Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina. Electronic address: sina.farsiu@duke.edu.
Duke University · USDuke Medical Center · USEmmes (United States) · USNational Eye Institute · USScripps Research Institute · US

Funding

VISION RESEARCHP30EY005722 · NEI · DUKE UNIVERSITY · PI Vadim Y Arshavsky · 1985 to 2026
$19.3M
NEI Intramural Biorepository for Retinal Diseases (12-EI-0042)ZIAEY000514 · NEI · NATIONAL EYE INSTITUTE · PI KEENAN, TIARNAN · 2012 to 2025
$2.0M
Computer Aided Classification of Diabetic Macular EdemaR01EY022691 · NEI · DUKE UNIVERSITY · PI FARSIU, SINA · 2012 to 2016
$1.9M
NEI NIH HHS P30 EY005722NEI NIH HHS R01 EY022691
6 · The paper itself

Abstract

purposeTo validate the efficacy of a fully automatic, deep learning-based segmentation algorithm beyond conventional performance metrics by measuring the primary outcome of a clinical trial for macular telangiectasia type 2 (MacTel2).

designEvaluation of diagnostic test or technology.

participantsA total of 92 eyes from 62 participants with MacTel2 from a phase 2 clinical trial (NCT01949324) randomized to 1 of 2 treatment groups

methodsThe ellipsoid zone (EZ) defect areas were measured on spectral domain OCT images of each eye at 2 time points (baseline and month 24) by a fully automatic, deep learning-based segmentation algorithm. The change in EZ defect area from baseline to month 24 was calculated and analyzed according to the clinical trial protocol.

main outcome measureDifference in the change in EZ defect area from baseline to month 24 between the 2 treatment groups.

resultsThe difference in the change in EZ defect area from baseline to month 24 between the 2 treatment groups measured by the fully automatic segmentation algorithm was 0.072±0.035 mm

conclusionsThe fully automatic segmentation algorithm was as accurate as semiautomatic expert segmentation to assess EZ defect areas and was able to reliably reproduce the statistically significant primary outcome measure of the clinical trial. This approach, to validate the performance of an automatic segmentation algorithm on the primary clinical trial end point, provides a robust gauge of its clinical applicability.

Indexed as

Deep LearningTomography, Optical CoherenceCiliary Neurotrophic FactorDrug ImplantsFemaleFluorescein AngiographyHumansMaleReproducibility of ResultsRetinal Photoreceptor Cell Inner SegmentRetinal Photoreceptor Cell Outer SegmentRetinal TelangiectasisRetinal VesselsTreatment OutcomeVisual AcuityVisual FieldsCiliary Neurotrophic FactorDrug Implants

Identifiers

PMID32019699
PMCPMC7246171
OpenAlexW2997639937

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.