UMIN-CTR Clinical Trial

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

Epiretinal membrane

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nihon University hospital

Institute

Department

Personal name

Organization

Nihon University hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

日本大学病院（東京都）

Date of disclosure of the study information

2018

Year

02

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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