Evidence map›Paper›PMID 39356386›Full record

Trial reportJapanese journal of ophthalmology2024

Comprehensive combined analysis of physician-initiated phase II and III clinical trials on a cultured human corneal endothelial cell product for treating bullous keratopathy.

Morio Ueno, Kojiro Imai, Yasufumi Tomioka, Go Horiguchi, Takanori Kameda, Satoshi Teramukai, Akitaka Tsujikawa, Tsutomu Inatomi, Chie Sotozono, Shigeru Kinoshita

Abstract readMulticenter StudyClinical Trial, Phase IIClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Japanese journal of ophthalmology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Trial
  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

10 authors.

Morio UenoDepartment of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Kojiro ImaiDepartment of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Yasufumi TomiokaDepartment of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Go HoriguchiDepartment of Biostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Takanori KamedaDepartment of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Satoshi TeramukaiDepartment of Biostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Akitaka TsujikawaDepartment of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Tsutomu InatomiDepartment of Ophthalmology, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan.
Chie SotozonoDepartment of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Shigeru KinoshitaDepartment of Frontier Medical Science and Technology for Ophthalmology, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto, 602-0841, Japan. shigeruk@koto.kpu-m.ac.jp.

Funding

Japan Agency for Medical Research and Development JP16bm0504002Japan Agency for Medical Research and Development JP19bk0104084
6 · The paper itself

Abstract

To evaluate the efficacy and safety of a cultured human corneal endothelial cell (cHCEC) product in eyes with bullous keratopathy (BK). Combined analysis of multicenter phase II and III clinical trials. This analysis involved 15 BK eyes in the phase II trial and 12 BK eyes in the phase III trial that underwent cHCEC transplant therapy. Safety was assessed in all the cases. Efficacy was assessed in 17 cases with exclusion of the low- and medium-dose groups in the phase II trial. The primary endpoint was a corneal endothelial cell density of 1000 cells/mm

Indexed as

Corneal DiseasesEndothelium, CornealVisual AcuityAdultAgedAged, 80 and overCell CountCells, CulturedCorneal TransplantationFemaleFollow-Up StudiesHumansMaleMiddle AgedTreatment OutcomeBullous keratopathyCell transplant therapyCultured corneal endothelial cellsPhysician-initiated multicenter clinical trialRho-associated protein kinase inhibitor

Identifiers

PMID39356386

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

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.