UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056826 |
|---|---|
| Receipt number | R000064947 |
| Scientific Title | Innovative Treatment Study Using Preserved Acellular Descemet Membrane in Refractory Macular Hole Surgery |
| Date of disclosure of the study information | 2025/01/27 |
| Last modified on | 2026/01/28 10:35:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Innovative Treatment Using Preserved Acellular Descemet Membrane for Refractory Macular Hole
Acronym
PADM for Macular Hole Surgery
Scientific Title
Innovative Treatment Study Using Preserved Acellular Descemet Membrane in Refractory Macular Hole Surgery
Scientific Title:Acronym
PADM for Macular Hole Surgery
Region
| Japan |
Condition
Condition
Refractory macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The combination of vitrectomy and internal limiting membrane peeling has been established as a standard approach for the treatment of full-thickness macular hole, with a closure rate exceeding 90%. However, certain cases, such as large macular holes exceeding 0.4mm, chronic macular holes, high myopia, and diabetic retinopathy, may result in failure to achieve closure postoperatively. For such cases, the inverted ILM flap technique has been widely accepted as a promising method, offering a closure rate of over 90% even for large macular holes. Nevertheless, some refractory cases remain unclosed despite the use of this technique.
For cases where initial surgery fails to close the macular hole or recurrence occurs after closure, various surgical approaches have been attempted, including free ILM flap, autologous retina transplantation, lens capsular flap transplantation, and human amniotic membrane (hAM) transplantation. However, no universal consensus has been reached regarding the ideal surgical technique for refractory macular holes. In the past, treatments using fresh corneal-derived Descemet membrane grafts for refractory macular holes have been reported, demonstrating certain levels of success.
The purpose of this study is to evaluate the efficacy and safety of using preserved acellular Descemet membrane, derived from corneal tissue, as a graft material for refractory macular holes that have proven difficult to close using existing techniques.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence or absence of macular hole closure, as evaluated by optical coherence tomography (OCT), during a postoperative period (e.g., at the time of intraocular gas absorption, 1 month postoperatively, 3 months postoperatively, or 6 months postoperatively).
Key secondary outcomes
During the postoperative period (e.g., at the time of intraocular gas absorption, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, etc.), best-corrected visual acuity (BCVA; measured using a standard logarithmic visual acuity chart and converted to logMAR), macular sensitivity (evaluated based on thresholds measured using static perimetry and Micro Perimeter 3), changes in intraocular pressure (IOP), and macular structure analyzed using optical coherence tomography (OCT), among others.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone vitrectomy with Descemet membrane transplantation for refractory macular holes at Yokohama Minami Kyosai Hospital, Nihon University Itabashi Hospital, Yokohama City University Hospital, or Kikuna Yuda Eye Clinic, and for whom informed consent has been obtained.
Key exclusion criteria
Patients with poor compliance to follow-up or those unable to tolerate surgery due to systemic disease or severe ocular inflammation are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Mizuki |
Organization
Yokohama Minami Kyosai Hospital
Division name
Department of Ophthalmology
Zip code
236-0037
Address
1-21-1 Mutsuura Higashi, Kanazawa-ku, Yokohama City, Kanagawa Prefecture, Japan
TEL
0457822101
mizuki.yuk.xj@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mizuki |
Organization
Yokohama Minami Kyosai Hospital
Division name
Department of Ophthalmology
Zip code
236-0037
Address
1-21-1 Mutsuura Higashi, Kanazawa-ku, Yokohama City, Kanagawa Prefecture, Japan
TEL
0457822101
Homepage URL
mizuki.yuk.xj@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama Minami Kyosai Hospital
Institute
Department
Personal name
Yuki Mizuki
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nihon Univercity Itabashi Hospital, Yokohama City University Hospital, Kikuna Yuda Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama Minami Kyousai Hospital
Address
1-21-1 Mutsuura Higashi, Kanazawa-ku, Yokohama City, Kanagawa Prefecture, Japan
Tel
0457822101
mizuki.yuk.xj@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜南共済病院、日本大学医学部付属板橋病院、横浜市立大学附属病院、きくな湯田眼科
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The study is ongoing with participant enrollment and follow-up in progress. Results will be posted after completion of follow-up and final analyses/manuscript preparation.
Results date posted
| 2026 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study aimed at evaluating the safety and efficacy of a new treatment for macular holes.
This study has been approved by the ethics committee. No funding is provided for this research.
Recruitment ongoing.
Management information
Registered date
| 2025 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064947
