Evidence map›Paper›PMID 36056443›Full record

ArticleTrials2022

The efficacy of micropulse laser combined with ranibizumab in diabetic macular edema treatment: study protocol for a randomized controlled trial.

Xuejing Mi, Xiaoya Gu, Xiaobing Yu

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03690947 (Randomized, Double-blinded, Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of Diabetic Macular Edema), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 35% 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.

NCT03690947 phase4completednot on this map

Randomized, Double-blinded, Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of Diabetic Macular Edema

TypeinterventionalSponsorBeijing HospitalRan2018 to 2021Enrolled72ConditionsDiabetic Macular EdemaArmsIntravitreal Ranibizumab, Micropulse Laser, Intravitreal Ranibizumab as needed
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
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

3 authors at 1 institution in 1 country.

Xuejing MiDepartment of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Xiaoya GuDepartment of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Xiaobing YuDepartment of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, 100730, China. yuxiaobing@sina.com.ORCID http://orcid.org/0000-0001-6480-6335
Chinese Academy of Medical Sciences & Peking Union Medical College · CN

Funding

Beijing Hospital BJ-2019-154Beijing Municipal Science and Technology Commission Z181100001718079
6 · The paper itself

Abstract

backgroundAt present, intraocular injection of anti-VEGF (vascular endothelial growth factor) drugs has replaced traditional laser therapy as the first-line treatment for DME (diabetic macular edema). However, ranibizumab, a commonly used anti-VEGF drug, is expensive and requires multiple intraocular injections. It places a heavy economic burden on patients with DME. Micropulse laser is safer than conventional laser and can reduce edema. Combined treatment with anti-VEGF may reduce the number of intraocular injections. This study will compare the efficacy of micropulse laser combined with ranibizumab treatment to ranibizumab monotherapy in the treatment of DME, providing a new regimen for future DME treatment.

methodsThis study is a prospective randomized double-blind controlled clinical trial (RCT) in patients with DME. After 1-year follow-up, visual acuity and macular edema regression will be compared between micropulse laser combined with ranibizumab group and ranibizumab monotherapy group to determine whether the efficacy of micropulse laser combined with ranibizumab treatment was not lower than that of ranibizumab monotherapy in the treatment of DME. Visual acuity measured by the ETDRS chart is the primary outcome measure. The secondary outcome measures are CMT (central macular thickness) measured by OCT (optical coherence tomography) and the number of injections of two groups. Changes in visual acuity and CMT of the two groups will be compared at 12-month follow-up. Before patients are recruited, we provide them with informed consent, in which we explain to them the purpose and process of the study. DISCUSSION: Micropulse laser combined with anti-VEGF drugs in the treatment of DME can reduce the number of intravitreal anti-VEGF injections, not only relieve the pain of the patients, but also ease the economic and psychological burden of patients, bringing great benefits. However, there is no treatment consensus for the parameters and specific methods of micropulse laser treatment for DME. There is a lack of clinical research data reference of micropulse laser combined with anti-VEGF therapy in clinical practice. This study intends to provide a new direction for clinical DME treatment and also provide a realistic consideration for the application of micropulse laser in DME treatment.

trial registrationClinicalTrials.gov NCT03690947. Registered on 1 October 2018.

Indexed as

Diabetes MellitusDiabetic RetinopathyLaser TherapyMacular EdemaAngiogenesis InhibitorsAntibodies, MonoclonalCombined Modality TherapyHumansProspective StudiesRandomized Controlled Trials as TopicRanibizumabTomography, Optical CoherenceTreatment OutcomeVascular Endothelial Growth Factor AAngiogenesis InhibitorsAntibodies, MonoclonalRanibizumabVascular Endothelial Growth Factor AAnti-VEGF injectionsDiabetic macular edemaMicropulse laserProtocol

Identifiers

PMID36056443
PMCPMC9438173
OpenAlexW4294219215

What OpenQuestion holds

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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.