UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031737 |
|---|---|
| Receipt number | R000036237 |
| Scientific Title | Evaluating the efficiency of Custom-made Scleral Contact lens for severe limbal stem cell deficiency. |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2023/03/21 12:15:50 |
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Basic information
Public title
Evaluating the efficiency of Custom-made Scleral Contact lens for severe limbal stem cell deficiency.
Acronym
Evaluating the efficiency of Custom-made Scleral Contact lens
Scientific Title
Evaluating the efficiency of Custom-made Scleral Contact lens for severe limbal stem cell deficiency.
Scientific Title:Acronym
Evaluating the efficiency of Custom-made Scleral Contact lens
Region
| Japan |
Condition
Condition
Severe limbal stem cell deficiency.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with severe stem cell deficiency,the long-term prognosis of penetrating keratoplasty,lamelar keratoplasty,and limbal transplantation is for,and the severe corneal opacity leads to severe visual dysfunction.
To date,there is no standardized treatment to obtain visual improvement in case soft every stem cell deficiency,
We developed a gimbal supported scleral contact lens used non-surgical method.
The aim of this study was to evaluate the efficacy of custom-maid scleral lens for severe limbal stem cell deficiency.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The best corrective visual acuity with scleral lens.
Key secondary outcomes
The pollution of contact lens.
The time and frequency of contact lens -wearing
The change of anterior and posterior curve of cornea with scleral lens wearing.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
We check the corrective visual acuity with scleral lens in every 3-6 month.
We ask the condition about the use of of lens with in every 3-6 month.
We measured the curve of cornea by corneal topography in every 3-6 month.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who can continue using the scleral lens for severe stem cell deficiency includingSteven-Jhonsons=syndrome.
Over 16 years old.
Key exclusion criteria
Under 15 years old
the patient who judged as inappropriate for this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Sotozono |
Organization
Kyoto prefectural university of medicine
Division name
Ophthalmology
Zip code
602-8566
Address
465 kajiicho kamigyoku kyoto japan
TEL
075-251-5578
csotozon@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Sotozono |
Organization
Kyoto peprfectual university of medicine
Division name
Ophthalmology
Zip code
602-8566
Address
465 kajiicho kamigyoku kyoto japan
TEL
075-251-5578
Homepage URL
csotozon@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto peprfectual university of medicine
Institute
Department
Personal name
Funding Source
Organization
SUN CONTACT Co
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address
465 Kajiicho Kamigyo-ku Kyoto
Tel
075-251-5337
rinri@koto.kpu-m.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32513522/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32513522/
Number of participants that the trial has enrolled
59
Results
Reported on 10 cases during the process.
The results are shown below
After 3 months of CL use, BCVA improved significantly (LogMAR: 0.76-0.15) compared to baseline (P=0.0039), all NEI VFQ-25 scores improved, and eye pain and mental status also improved significantly (P=0.0078 and 0.0039). No serious adverse events were observed during the follow-up period.
Results date posted
| 2022 | Year | 09 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Chronic SJS/TEN eyes that were fitted with a limbal-supported CL.
Participant flow
After prescribing scleral lenses, the effectiveness and long-term follow-up of the lenses were verified.
Adverse events
There were 2 adverse events involving conjunctival epithelial erosion. In those 2 eyes, the small conjunctival epithelial erosion was healed within several days after the removal of the CL. No other complications or infections occurred as a result of the CL wear.
Outcome measures
The main outcome measure was BCVA at baseline (i.e. obtained via the use of spectacles prior to the fitting of the CL) and at post 3-months use of the CL (i.e. with the fitted CL being worn). The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) score was defined as the secondary outcome.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036237
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