Evidence map›Paper›PMID 36574847›Full record

Observational studyOphthalmology2023

Validation of Rates of Mean Deviation Change as Clinically Relevant End Points for Glaucoma Progression.

Felipe A Medeiros, Alessandro A Jammal

Abstract readObservational Study
In one paragraph

Observational study in Ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Observational
  5. Article
  6. Article
  7. Observational
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Validating Trend-Based End Points for Neuroprotection Trials in Glaucoma.Translational vision science & technology · 2023
    Article
  14. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Felipe A MedeirosVision, Imaging and Performance Laboratory, Duke Eye Center, Duke University, Durham, North Carolina; Department of Electrical and Computer Engineering, Pratt School of Engineering, Duke University, Durham, North Carolina; Department of Biostatistics and Bioinformatics, Duke University School Medicine, Durham, North Carolina. Electronic address: felipe.medeiros@duke.edu.
Alessandro A JammalVision, Imaging and Performance Laboratory, Duke Eye Center, Duke University, Durham, North Carolina.

Funding

The BCI (Brain Computer Interface) Glaucoma Study: Objective Home-Based Detection of Progressive Visual Function Loss in GlaucomaR01EY029885 · NEI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI ASRANI, SANJAY, MEDEIROS, FELIPE · 2019 to 2022
$2.2M
Objective Quantification of Neural Damage for Screening, Diagnosis and Monitoring of Glaucoma with Fundus PhotographsR21EY031898 · NEI · DUKE UNIVERSITY · PI MEDEIROS, FELIPE · 2020 to 2021
$437k
NEI NIH HHS R01 EY029885NEI NIH HHS R21 EY031898
6 · The paper itself

Abstract

purposeTo investigate whether rates of standard automated perimetry (SAP) mean deviation (MD) over an initial 2-year follow-up period were predictive of events of visual field progression over an extended follow-up.

designLongitudinal, prospective, observational study.

participantsTwo hundred forty-six eyes of 168 patients with glaucoma followed up every 6 months for up to 5 years.

methodsPatients were required to have a minimum of 5 reliable SAP tests during the first 2 years of follow-up. Events of progression were evaluated using 2 methods: Guided Progression Analysis (GPA; Carl Zeiss Meditec, Inc) and a United States Food and Drug Administration (FDA)-suggested end point. The date of the first test showing progression after the first 2 years was considered to be the event date. Rates of change in SAP MD were calculated for the first 2 years of follow-up, and joint longitudinal survival models were used to assess the risk of faster initial MD loss for subsequent progression based on each event analysis.

main outcome measureRisk of having an event of progression based on initial rates of SAP MD change.

resultsFifty-six eye (22.8%) showed an event of progression by the GPA and 51 eyes (20.7%) did so by the FDA end point. Each 0.1-dB/year faster rate of SAP MD loss in the first 2 years was associated with a 26% increase in risk of a GPA progression end point developing (R

conclusionsRates of SAP MD change for eyes with glaucoma calculated over the initial 2 years of follow-up were strongly predictive of events of progression over subsequent follow-up. Our findings give support for the use of slopes of MD change as suitable end points of progression in clinical trials. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Indexed as

GlaucomaIntraocular PressureDisease ProgressionFollow-Up StudiesHumansProspective StudiesVision DisordersVisual Field TestsClinical trial end pointGlaucomaMean deviationPerimetry, Progression

Identifiers

PMID36574847
PMCPMC10278199

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Registered trials

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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.