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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021220
Receipt No. 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

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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
Email 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
Email nakashizuka.hiroyuki@nihon-u.ac.jp

Sponsor
Institute Nihon University hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022216

Research Plan
Registered date File name
2018/10/05 視力良好ERM実施計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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