UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029116
Receipt number R000033300
Scientific Title Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy.
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/12 21:50:47

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Basic information

Public title

Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy.

Acronym

Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy.

Scientific Title

Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy.

Scientific Title:Acronym

Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy.

Region

Japan


Condition

Condition

primary open angle glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of cataract surgery on visual acuity, spherical equivalent and intraocular pressure on the eye after trabeculectomy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visual acuity
spherical equivalent
intraocular pressure

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Intervention for spherical equivalent examination.
Five interventions about 1 week, about 1 month, about 3 months, about 6 months, about 1 year later.

Interventions/Control_2

Intervention for eye axis length examination.
Five interventions about 1 week, about 1 month, about 3 months, about 6 months, about 1 year later.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

primary open angle glaucoma
after trabeculectomy
no eye surgery(control)
the need for surgery
surgery noly PEA+IOL

Key exclusion criteria

other than primary open angle glaucoma
In the study group, patients with ophthalmologic surgical history other than trabeculectomy
patients with ophthalmologic surgery history in the control group
patients with other eye disease

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name RYU IIKAWA

Organization

Niigata university

Division name

Ophthalmology

Zip code


Address

Niigata-city Chuo-ku Asahimachidori 1-757

TEL

025-223-6161

Email

ryu.iikawa@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name RYU IIKAWA

Organization

Niigata university

Division name

Ophthalmology

Zip code


Address

Niigata-city Chuo-ku Asahimachidori 1-757

TEL

025-223-6161

Homepage URL


Email

ryu.iikawa@gmailcom


Sponsor or person

Institute

Niigata university

Institute

Department

Personal name



Funding Source

Organization

Niigata university

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 01 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


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

Preinitiation

Date of protocol fixation

2017 Year 08 Month 29 Day

Date of IRB


Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 12 Day

Last modified on

2017 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033300


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name