UMIN-CTR Clinical Trial

Public title

Autonomic Response to Orthostatic Challenge is Impaired in patients with exudative Age-Related Macular Degeneration

Acronym

Autonomic Response to Orthostatic Challenge is Impaired in patients with exudative Age-Related Macular Degeneration

Scientific Title

Autonomic Response to Orthostatic Challenge is Impaired in patients with exudative Age-Related Macular Degeneration

Scientific Title:Acronym

Autonomic Response to Orthostatic Challenge is Impaired in patients with exudative Age-Related Macular Degeneration

Region

Japan

Condition

exudative Age-Related Macular Degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To explore evaluate the possible association of autonomic function activity and reactivity of orthostatic with and exudative age-related macular degeneration (AMD) in Japanese patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To assess autonomic function about sympathetic and parasympathetic, a standardized heart rate variability (HRV) analysis method , by using standard autonomic function tests was used to calculate the indexes for autonomic activities; low to high frequency power (LF/HF) for sympathetic tone and the coefficient of component variance in high frequency (CCVHF) for parasympathetic tone, and the reactive response to orthostatic challenge as their change from sitting to standing position.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

40

years-old

<

Age-upper limit

95

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients with exudative AMD requiring treatment and age-matched control subjects at the Ophthalmology at the Tokyo University Hospital between Feb and Oct 2014 were recruited to the study.
All patients with exudative AMD who are refractory to the injections of ranibizumab had been followed up for at least 12 months after the first injections of aflibercept treatment.
Control subjects were collected from subjects presenting for postoperative follow up examinations for cataract, epiretinal membrane, macular hole and nonspecific ocular complaints.

Key exclusion criteria

Patients with glaucoma using eye drops for intraocular pressure (IOP) lowering and/or on systemic medications such as cholinergic, adrenergic or angiotensin II receptor blocker drugs were excluded.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yasuo Yanagi

Organization

Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Division name

Department of Ophthalmology

Zip code

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan

TEL

+81-3-5800-8660

Email

yanagi-tky@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Yasuo Yanagi

Organization

Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Division name

Department of Ophthalmology

Zip code

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan

TEL

+81-3-5800-8660

Homepage URL

Email

yanagi-tky@umin.ac.jp

Institute

Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Institute

Department

Personal name

Organization

nothing

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

Date of disclosure of the study information

2015

Year

09

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

2014

Year

02

Month

06

Day

Date of IRB

Anticipated trial start date

2014

Year

02

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Patients with exudative AMD requiring treatment and age-matched control subjects at the Ophthalmology at the Tokyo University Hospital between Feb and Oct 2014 were recruited to the study.
All subjects were examined in a quiet room with standard temperature. An electrocardiogram (ECG) was equipped, and ECG measurements were made in a resting state of sitting position for 2 minutes, and, for a standing load, in a standing position for 2 minutes. Real-time analysis was performed using heart-rate variability (HRV) analysis software of CROSSWELL, Inc.

Registered date

2015

Year

09

Month

20

Day

Last modified on

2015

Year

09

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022024