UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000027586 |
| Receipt No. | R000031619 |
| Scientific Title | A prospective study of the outcomes of Descemet membrane endothelial keratoplasty (DMEK) |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2020/07/12 (Ver. 10) |
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| Basic information | ||
| Public title | A prospective study of the outcomes of Descemet membrane endothelial keratoplasty (DMEK) | |
| Acronym | A prospective study of Descemet membrane endothelial keratoplasty (DMEK) | |
| Scientific Title | A prospective study of the outcomes of Descemet membrane endothelial keratoplasty (DMEK) | |
| Scientific Title:Acronym | A prospective study of Descemet membrane endothelial keratoplasty (DMEK) | |
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| Condition | ||
| Condition | Bullous keratopathy | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | Descemet membrane endothelial keratoplasty
(DMEK) involving transplantation of only one layer of the endothelium and the thin Descemet membrane, results in quick and excellent improvement in postoperative visual acuity due to less irregularity on the anterior and posterior surfaces of the cornea, and to the very low incidence of post-operative graft rejection. Many ophthalmologists in Europe and the United States have started to perform DMEK in patients with Fuchs corneal endothelial dystrophy. However, it is thought to be a difficult procedure for Asian eyes, which tend to have a shorter axial length, narrower anterior chamber, darkly colored iris, and more advanced corneal edema resulting from various etiologies of bullous keratopathy, compared to Caucasian eyes. A prospective study of the efficacy of DMEK in Asian eye is necessary. BBG 250 (BBG; Sigma-Aldrich, St. Louis, MO, USA) was dissolved in balanced saline solution (BSS or BSS-plus; Alcon, Osaka, Japan) to 0.1% (w/v). All grafts were peeled as described previously. BBG (0.1%, w/v) was used to stain the graft edges during peeling. The donor membrane graft stained with 0.1% (w/v) BBG (1.0 mg/ml) was placed into an intraocular lens injector (model WJ-60M 1 or 2; Santen Pharmaceuticals, Osaka, Japan) and inserted into the anterior chamber. After the donor graft disc was loaded on an intraocular lens inserter (WJ-60M;Santen) with a small amount of OVD(Opegan; Santen) between the graft and the tip of the plunger |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Others |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | Visual acuity(logMAR),Endothelial Cell Density(ECD), Central Corneal Thickness(CCT),High-order Abberattions(HOAs), and VFQ-25 were assessed preoperatively, and at1,3, 6 months, 1, 2, 3, 4, and 5 years postoperatively. |
| Key secondary outcomes | Central retinal thickness, Cystoid macula edema(CME), posteior synechia, iris abnormality, operative time, graft unfolding timewere assessed preoperatively, and at1,3, 6 months, 1, 2, 3, 4, and 5 years postoperatively. |
| Base | |
| Study type | Observational |
| Study design | |
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| Blinding | |
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| Dynamic allocation | |
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| Blocking | |
| Concealment | |
| Intervention | |
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| Eligibility | ||||
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| Gender | Male and Female | |||
| Key inclusion criteria | Bullous keratopathy, Fuchs endothelial dystrophy, pseudo-exfoliation syndrome, birth injury, corneal endothelitis, eye with low corneal endothelial cell density, because of unknown factors | |||
| Key exclusion criteria | patient who dont agree with the research | |||
| Target sample size | 100 | |||
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| Organization | Yokohama Minami Kyosai Hospital | ||||||
| Division name | Department of Ophthalmology | ||||||
| Zip code | 236-0037 | ||||||
| Address | 1-21-1 Mutuurahigashi, kanazawa-ku, Yokohama, kanagawa, Japan | ||||||
| TEL | +81457872101 | ||||||
| htakahiko-aikou@unim.ac.jp | |||||||
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| Organization | Medical Techno | ||||||
| Division name | Department of Ophthalmology | ||||||
| Zip code | 2360037 | ||||||
| Address | Kanazawa-ku | ||||||
| TEL | +817038502167 | ||||||
| Homepage URL | https://www.minamikyousai.jp/ | ||||||
| takamed@gmail.com | |||||||
| Sponsor | |
| Institute | Department of Ophthalmology, Yokohama Minami Kyosai Hospital |
| Institute | |
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| Funding Source | |
| Organization | None |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
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| IRB Contact (For public release) | |
| Organization | Yokohama Minami Kyosai Hospital |
| Address | 1-21-1, Mutsuura-Higashi |
| Tel | +81457872101 |
| takamed@gmail.com | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
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| IND to MHLW | |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | https://journals.lww.com/corneajrnl/Abstract/2018/09000/Double_Bubble_Technique_in_Descemet_Membrane |
| Publication of results | Partially published |
| Result | |||||||
| URL related to results and publications | https://journals.lww.com/corneajrnl/Abstract/2018/09000/Double_Bubble_Technique_in_Descemet_Membrane | ||||||
| Number of participants that the trial has enrolled | 50 | ||||||
| Results | https://journals.lww.com/corneajrnl/Abstract/2018/09000/Double_Bubble_Technique_in_Descemet_Membrane |
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| Baseline Characteristics | DMEK patients |
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| Participant flow | DMEK patients |
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| Adverse events | Nothing |
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| Outcome measures | BCVA, ECD,rebubbling,graft failure, rejection rates, corneal nerve |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Other | |
| Other related information | Prospective, observatiol study |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031619 |
