Evidence map›Paper›PMID 37196877›Full record

ArticleBiomedical journal2024

Real-world effectiveness of intravitreal dexamethasone implants - Comparison between eyes eligible and ineligible for clinical trials and their associated outcomes.

Eugene Yu-Chuan Kang, Shih-Chieh Shao, Kai-Cheng Chang, Sunir J Garg, Tzu-Yi Lin, Kuan-Jen Chen, Wei-Chi Wu, Chi-Chun Lai, Yih-Shiou Hwang, Edward Chia-Cheng Lai

Abstract read
In one paragraph

Article in Biomedical journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
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

10 authors.

Eugene Yu-Chuan KangDepartment of Ophthalmology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan; Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Shih-Chieh ShaoDepartment of Pharmacy, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan; School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Electronic address: scshao@cgmh.org.tw.
Kai-Cheng ChangSchool of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Pharmacy, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
Sunir J GargMidAtlantic Retina, The Retina Service of Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA.
Tzu-Yi LinDepartment of Ophthalmology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
Kuan-Jen ChenDepartment of Ophthalmology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Wei-Chi WuDepartment of Ophthalmology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Chi-Chun LaiCollege of Medicine, Chang Gung University, Taoyuan, Taiwan; Department of Ophthalmology, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.
Yih-Shiou HwangDepartment of Ophthalmology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan; Department of Ophthalmology, Jen-Ai Hospital Dali Branch, Taichung, Taiwan.
Edward Chia-Cheng LaiSchool of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConcerns about the generalizability of pivotal randomized controlled trials (pRCTs) findings have been raised. We aimed to compare intravitreal dexamethasone implants' (IDIs) effectiveness for diabetic macular edema (DME) and central retinal vein occlusion (CRVO), between eyes eligible and ineligible for pRCTs.

methodsThis retrospective cohort study analyzed Taiwan's Chang Gung Research Database, including DME or CRVO eyes initiating IDIs during 2015-2020. We classified all treated eyes as eligible or ineligible for pRCTs following major selection criteria of the MEAD and GENEVA trials, and evaluated three-, six-, and twelve-month changes in central retinal thickness (CRT) and visual acuity (VA) after initiating IDIs.

resultsWe included 177 IDI-treated eyes (DME: 72.3%; CRVO: 27.7%), of which 39.8% and 55.1% were ineligible for DME and CRVO pRCTs, respectively. LogMAR-VA and CRT changes at different times were comparable in DME eyes eligible (LogMAR-VA difference: 0.11 to 0.16; CRT difference: -32.7 to -96.9 μm) and ineligible (LogMAR-VA difference: -0.01 to 0.15; CRT difference: -54.5 to -109.3 μm) for the MEAD trial. By contrast, CRVO eyes ineligible for the GENEVA trial had greater LogMAR-VA changes (0.37 ~ 0.50) than those eligible (0.05 ~ 0.13), with comparable CRT reductions (eligible eyes: -72.3 to -106.4 μm; ineligible eyes: -61.8 to -110.7 μm) (all p-values <0.05 of the mean differences between eligible and ineligible CRVO eyes for all follow-ups).

conclusionsIDIs had similar VA and CRT outcomes among DME eyes, regardless of pRCT-eligibility. However, among CRVO eyes, those ineligible for pRCTs showed greater deterioration in VA than those eligible.

Indexed as

Diabetic RetinopathyMacular EdemaRetinal Vein OcclusionDexamethasoneHumansRetrospective StudiesTomography, Optical CoherenceTreatment OutcomeVascular Endothelial Growth Factor ADexamethasoneVascular Endothelial Growth Factor ACentral retinal vein occlusionDiabetic macular edemaIntravitreal dexamethasone implantOutcomesTrial eligibilities

Identifiers

PMID37196877
PMCPMC10826172

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LicenceCC BY-NC-ND
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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.