Evidence map›Paper›PMID 33451297›Full record

Trial reportBMC ophthalmology2021

Title: efficacy of intravitreal dexamethasone implant on hard exudate in diabetic macular edema.

Chang Ki Yoon, Min Sagong, Jae Pil Shin, Sang Joon Lee, Joo Eun Lee, Ji Eun Lee, Inyoung Chung, Woo Jin Jeong, Kang Yeun Pak, Hyun Woong Kim

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC ophthalmology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02399657 (A Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Dexamethasone Implant), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT02399657 phase4unknown statusnot on this map

A Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Dexamethasone Implant (Ozurdex®) on Hard Exudates of Diabetic Macular Edema

TypeinterventionalSponsorInje UniversityRan2015 to 2016Enrolled48ConditionsDiabetes Mellitus, Macular Edema, Retinal Exudates and DepositsArmsIntravitreal dexamethasone 0.7mg implant
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Hard exudates in diabetic macular edema after intravitreal anti-VEGF therapy: a post-hoc analysis of the DRCR protocol T trial.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
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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.

Chang Ki YoonDepartment of Ophthalmology, Seoul National University Hospital, Seoul, Korea.
Min SagongDepartment of Ophthalmology, Yeungnam University College of Medicine, Daegu, Korea.
Jae Pil ShinDepartment of Ophthalmology, School of Medicine, Kyungpook National University, Daegu, Korea.
Sang Joon LeeDepartment of Ophthalmology, Kosin University college of medicine, Gospel Hospital, Busan, Korea.
Joo Eun LeeJ Eye Center, Busan, Korea.
Ji Eun LeeCollege of Medicine, Pusan National University, Yangsan, Korea.
Inyoung ChungInstitute of Health Sciences, Gyeongsang National University Hospital, Gyeongsang National University, Jinju, Korea.
Woo Jin JeongDong-A University Hospital, Busan, Korea.
Kang Yeun PakInje Univertisy, Haeundae Paik hospital, 875, Haeun-daero, Haeundae-gu, 48108, Busan, Korea.
Hyun Woong KimInje Univertisy, Haeundae Paik hospital, 875, Haeun-daero, Haeundae-gu, 48108, Busan, Korea. maekbak@gmail.com.ORCID http://orcid.org/0000-0003-2595-601X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo investigate the effect of intravitreal dexamethasone implant (DEX implant) on hard exudate (HE) accompanying diabetic macular edema (DME).

methodsThis study was a non-comparative non-randomized 1-year prospective interventional study. Patients with DME and HE were treated using DEX implant two or three times. Color fundus photography and optical coherence tomography (OCT) were performed at every visit. HE area was measured semi-automatically from the fundus photographs.

resultsThirty-five patients completed the study. Eleven patients (31.4%) received two injections, while the remaining received three times. HE area (primary outcome) significantly decreased from 1.404±2.094 mm2 (baseline) to 0.212±0.592 mm2 (last visit), which was 24% of the baseline HE area (P<0.001). HE1500 (HE within 1500 μm from the fovea) area also decreased significantly from 0.382±0.467 mm2 to 0.066±0.126 mm2 (P<0.001). Furthermore, anaverage best corrected visual acuity (BCVA) improvement of 4.4 Early Treatment Diabetic Retinopathy Study (ETDRS) letters was observed (from 49.9±18.3 to 54.3±20.4 letters) (P= 0.008). Central macular thickness (CMT) decreased from 455.8±23.6 μm to 366.8±31.1 μm (P=0.009). Repetitive measurements for entire study duration was analyzed using generalized estimating equations (GEE), where BCVA was related to age, CMT, and HE1500 area in multivariate analyses.

conclusionDEX implant could reduce and suppress HE in DME for one year with two or three injections. And centrally located HE area (HE1500 area) is related to vision.

trial registrationClinicalTrials.gov, NCT02399657 , Registered 26 March 2015.

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaDexamethasoneDrug ImplantsExudates and TransudatesGlucocorticoidsHumansIntravitreal InjectionsProspective StudiesTomography, Optical CoherenceVisual AcuityDexamethasoneDrug ImplantsGlucocorticoidsDexamethasoneDiabetic retinopathyExudateIntravitreal injectionMacular edema

Identifiers

PMID33451297
PMCPMC7811249

What OpenQuestion holds

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LicenceCC BY
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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.