UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041141 |
|---|---|
| Receipt number | R000046987 |
| Scientific Title | Evaluation of the pre- and postoperative visual outcomes of phacoemulsification in patients with uveitis-associated cataract. |
| Date of disclosure of the study information | 2020/07/17 |
| Last modified on | 2020/07/17 20:24:22 |
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Basic information
Public title
Evaluation of the pre- and postoperative visual outcomes of phacoemulsification in patients with uveitis-associated cataract.
Acronym
Evaluation of the pre- and postoperative visual outcomes of phacoemulsification in patients with uveitis-associated cataract.
Scientific Title
Evaluation of the pre- and postoperative visual outcomes of phacoemulsification in patients with uveitis-associated cataract.
Scientific Title:Acronym
Evaluation of the pre- and postoperative visual outcomes of phacoemulsification in patients with uveitis-associated cataract.
Region
| Japan |
Condition
Condition
Uveitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pre- and postoperative outcomes of phacoemulsification, such as aqueous flares in the anterior chamber objectively as intraocular inflammation in patients with uveitis-associated cataract during remission, and compare to control subjects.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraocular inflammation measured by laser flare cell meter
Key secondary outcomes
Clinical findings
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
/The patients aged older than 50 years who were required cataract surgery with IOL implantation were included. Before surgery, quiescence of intraocular inflammation for more than 3 months with absence of systemic immunosuppressive therapy was a pre-requisite for eligibility for the surgery in patients with uveitis.
/Patients without
/Patients who had not undergone intraocular surgery.
Key exclusion criteria
/The patients with any previous ocular surgery in the eligible eye, preoperative trauma, pre-existing macular pathologies, vitreous hemorrhage, diabetes mellitus, rhegmatogenous retinal detachment, ocular surface disorders, glaucoma uncontrolled with medical treatment, and optic atrophy which were likely to affect surgical outcome, were excluded from the study.
/Patients with systemic immunsuppressive therapy.
/Patients who had undergone intraocular surgery.
/Patients who were judged as no application by doctor.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Koh-Hei |
| Middle name | |
| Last name | Sonoda |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Ophthalmology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5648
sonodak@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsunobu |
| Middle name | |
| Last name | Takeda |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Ophthalmology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5648
Homepage URL
atakeda@med.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
AMO Japan, Ltd.
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
Graduate School of Medical Sciences, Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel
092-642-5648
sonodak@med.kyushu-u.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
九州大学病院、国立病院機構九州医療センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 17 | 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
67
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Preparing manuscript submission.
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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 07 | Month | 17 | Day |
Last modified on
| 2020 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046987
