UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021220 |
|---|---|
| Receipt number | R000022216 |
| Scientific Title | Surgical Outcomes of Vitrectomy for Epiretinal Membrane with Good Visual Acuity-better than 0.9 decimal visual acuity |
| Date of disclosure of the study information | 2018/02/26 |
| Last modified on | 2018/10/05 12:56:42 |
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Basic information
Public title
Surgical Outcomes of Vitrectomy for Epiretinal Membrane with Good Visual Acuity-better than 0.9 decimal visual acuity
Acronym
Surgical Outcomes of Vitrectomy for Epiretinal Membrane with Good Visual Acuity
Scientific Title
Surgical Outcomes of Vitrectomy for Epiretinal Membrane with Good Visual Acuity-better than 0.9 decimal visual acuity
Scientific Title:Acronym
Surgical Outcomes of Vitrectomy for Epiretinal Membrane with Good Visual Acuity
Region
| Japan |
Condition
Condition
Epiretinal membrane
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of ERM removal in patients with better than 0.9 decimal visual acuity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
The horizontal metamorphopsia at 6 months after surgery
Key secondary outcomes
Visual acuity, The horizontal metamorphopsia at 1,3,12 months after surgery, The vertical metamorphopsia at 1,3,6,12 months after surgery, The streopsis at 1,3,6,12 months after surgery, Central foveal thickness and continuity of IS/OS line, Reading score, National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25), Pathological findings
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Vitrectomy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients with epiretinal membrane
2 Visual acuity better than 0.9 decimal unit
3 No cataract to influence visual acuity
Key exclusion criteria
1 Eyes performed vitrectomy before
2 Eyes which have other diseases such as inflammatory or vascular diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nakashizuka |
Organization
Nihon University hospital
Division name
Ophthalmology
Zip code
Address
1-6surugadai kanda chiyoda-ku
TEL
03-3293-1711
nakashizuka.hiroyuki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nakashizuka |
Organization
Nihon University hospital
Division name
Ophthalmology
Zip code
Address
1-6surugadai kanda chiyoda-ku
TEL
03-3293-1711
Homepage URL
nakashizuka.hiroyuki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 26 | 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
[Purpose] To evaluate the efficacy of epiretinal membrane removal in patients with good visual acuity for improving visual function and quality of life (QOL).
[Subjects and Methods] A prospective case study. 37 subjects with good visual acuity better than 0.9 (good group) was compared to 35 patients with visual acuity of 0.3 to 0.8 (moderate group) in 3-and 6-month data. Linear mixed-effect models were used for statistical analysis. The primary outcome was 6 months postoperative horizontal metamorphopsia (MH). Secondary outcomes are postoperative visual acuity, 1,3,6-months postoperative MH, vertical metamorphopsia (MV), aniseikonia, streopsis, and central foveal thickness. In the good group, QOL assessment using NEI VFQ 25 at 6 and 12 months was examined.
[Results] In good group, MH was improved significantly from 0.84 to 0.44 degree at 3 months, 0.45 degree at 6 months and 0.36 degree at 12 months after surgery (P<0.0001, respectively), however there was no significant difference from the moderate VA group. There was no improvement in MV score at the final observation in both groups. LogMAR VA significantly improved from -0.09 preoperatively to -0.046 at 12 months in good group and was significantly better than moderate group. Preoperative vertical and horizontal aniseikonia score remained unchanged in good group at 6 months (P = 0.75, 0.71), while in moderate group, both vertical and horizontal aniseikonia score worsened(P = 0.01, 0.01). The NEI VFQ-25 score improved in good VA group by general health, general vision, mental health.
Results date posted
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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 14 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 14 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 14 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 26 | Day |
Last modified on
| 2018 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022216
