Evidence map›Paper›PMID 30165894›Full record

ArticleTrials2018

Inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment in high myopia: study protocol for a randomized controlled clinical trial.

Ying Zheng, Mei Kang, Hong Wang, Haiyun Liu, Tao Sun, Xiaodong Sun, Fenghua Wang

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

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03383731 (A Single Center, Randomized and Controlled Clinical Study of Inverted Internal Limiting Membrane Insertion Combined With Air Tamponade in the Treatment of Macular Hole Retinal Detachment in High Myopia), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 24% 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.

NCT03383731 naunknown statusnot on this map

A Single Center, Randomized and Controlled Clinical Study of Inverted Internal Limiting Membrane Insertion Combined With Air Tamponade in the Treatment of Macular Hole Retinal Detachment in High Myopia

TypeinterventionalSponsorShanghai General Hospital, Shanghai Jiao Tong University School of MedicineRan2017 to 2020Enrolled38ConditionsMacular Holes, Retinal Detachment, High MyopiaArmsGroup 1, Group 2
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. 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

7 authors at 1 institution in 1 country.

Ying ZhengDepartment of Ophthalmology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Building 1, No.100, Haining Road, Shanghai, 200080, China.
Mei KangClinical Research Center, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Hong WangDepartment of Ophthalmology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Building 1, No.100, Haining Road, Shanghai, 200080, China.
Haiyun LiuDepartment of Ophthalmology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Building 1, No.100, Haining Road, Shanghai, 200080, China.
Tao SunDepartment of Ophthalmology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Building 1, No.100, Haining Road, Shanghai, 200080, China.
Xiaodong SunDepartment of Ophthalmology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Building 1, No.100, Haining Road, Shanghai, 200080, China.
Fenghua WangDepartment of Ophthalmology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Building 1, No.100, Haining Road, Shanghai, 200080, China. shretina@sjtu.edu.cn.ORCID http://orcid.org/0000-0001-9670-1036
Shanghai First People's Hospital · CN

Funding

Clinical Research Innovation Plan of Shanghai General Hospital CTCCR-2016B02
6 · The paper itself

Abstract

backgroundMacular hole retinal detachment (MHRD) occurs most commonly in high myopia and causes severe visual impairment and greatly reduces the quality of life. The aim of this study is to evaluate the efficacy and safety of inverted internal limiting membrane insertion combined with air tamponade in the treatment of MHRD in high myopia, and also to compare the treatment efficacy with that of the conventional "vitrectomy plus internal limiting membrane peeling plus silicone oil tamponade" method for high myopia-associated MHRD. METHODS/

designIn this clinical trial, 38 patients with MHRD in high myopia will be randomly assigned to two groups (Group 1: standard 3-port 23-gauge pars plana vitrectomy plus internal limiting membrane peeling plus air-fluid exchange plus silicone oil infusion; Group 2: standard 3-port 23-gauge pars plana vitrectomy plus internal limiting membrane peeling plus inverted internal limiting membrane insertion plus air-fluid exchange). The primary outcome is macular hole closure rate in 3 months after the initial surgery. The secondary outcomes are best corrected visual acuity (BCVA), reattachment rate of retinal detachment, and postoperative complication rate. DISCUSSION: The study results may help to evaluate the efficacy and safety of inverted internal limiting membrane insertion combined with air tamponade in the treatment of MHRD in high myopia, and also compare the efficacy of the new treatment with the conventional "vitrectomy plus internal limiting membrane peeling plus silicone oil tamponade" method. This trial may provide a novel surgical treatment for MHRD in high myopia with more effectiveness and less pain.

trial registrationClinicalTrials.gov, NCT03383731 . Registered on 19 December 2017. Retrospectively registered.

Indexed as

AdultAgedChinaEpiretinal MembraneFemaleHumansMaleMiddle AgedMyopiaProspective StudiesRandomized Controlled Trials as TopicRecovery of FunctionRetinal DetachmentRetinal PerforationsSilicone OilsTreatment OutcomeSilicone OilsAir tamponadeHigh myopiaInverted internal limiting membrane insertionMacular hole retinal detachment

Identifiers

PMID30165894
PMCPMC6117933
OpenAlexW2889447299

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.