UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013526
Receipt number R000015808
Scientific Title Randomized double-masked comparative study of intraocular pressure and wound status between eyes immediately after scleral tunnel incision and clear corneal incision cataract surgery
Date of disclosure of the study information 2014/03/27
Last modified on 2014/03/27 10:40:45

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Basic information

Public title

Randomized double-masked comparative study of intraocular pressure and wound status between eyes immediately after scleral tunnel incision and clear corneal incision cataract surgery

Acronym

Intraocular pressure and wound status in eyes immediately after scleral tunnel and clear corneal incision cataract surgery

Scientific Title

Randomized double-masked comparative study of intraocular pressure and wound status between eyes immediately after scleral tunnel incision and clear corneal incision cataract surgery

Scientific Title:Acronym

Intraocular pressure and wound status in eyes immediately after scleral tunnel and clear corneal incision cataract surgery

Region

Japan


Condition

Condition

Cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to compare intraocular pressure (IOP) and wound structure immediately after scleral tunnel incision or clear corneal incision cataract surgery.

Basic objectives2

Others

Basic objectives -Others

To confirm the changes in IOP is more stable and the wound structure is stronger after scleral tunnel incision than after clear corneal incision cataract surgery.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

1) Longitudinal changes in intraocular pressure (IOP) using rebound tonometer after cataract surgery preoperatively, at the conclusion of surgery; and at 5, 10, 15, 30, and 60 minutes postoperatively.
2) Wound structure at 30 minutes postoperatively using the anterior segment-optical coherence tomography (AS-OCT)

Key secondary outcomes

3) Wound leakage at 30 minutes after surgery examined using the Seidel test
4) Flare intensity at 45 minutes after surgery determined using the flare meter


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Phacoemulsification surgery using scleral tunnel incision with 2.4 mm in length in unilateral eyes of 64 enrolled patients

Interventions/Control_2

Phacoemulsification surgery using clear corneal incision with 2.4 mm in length in fellow eyes of 64 enrolled patients

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All consecutive patients who were scheduled for bilateral cataract surgery at the Hayashi Eye Hospital from May 10, 2013. Bilateral eyes of 64 patients scheduled for cataract surgery were randomized to 1 of 2 groups: A) 32 patients who were to undergo a 2.4-mm scleral tunnel incision cataract surgery in the right eye and 2.4-mm clear corneal incision in the left eye, or B) 32 patients who were to undergo a 2.4-mm scleral tunnel incision cataract surgery in the left eye and 2.4-mm clear corneal incision in the right eye.

Key exclusion criteria

Exclusion criteria were eyes with any pathology of the cornea, vitreous body, macula, or optic nerve; eyes with glaucoma or ocular hypertension; eyes with pseudoexfoliation syndrome; eyes scheduled for planned extracapsular cataract extraction; a history of previous ocular surgery or inflammation; patients with diabetes; patient refusal; and any anticipated difficulties with examination or follow up

Target sample size

64


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken Hayashi

Organization

Hayashi Eye Hospital

Division name

Department of ophthalmology

Zip code


Address

4-23-35,hakataekimae, hakata-ku,Fukuoka-city, Fukuoka

TEL

092-431-1680

Email

hayashi-ken@hayashi.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ken Hayashi

Organization

Hayashi Eye Hospital

Division name

Department of ophthalmology

Zip code


Address

4-23-35,hakataekimae, hakata-ku,Fukuoka-city, Fukuoka

TEL

092-431-1680

Homepage URL


Email

hayashi-ken@hayashi.or.jp


Sponsor or person

Institute

Hayashi Eye Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

林眼科病院(福岡県)Hayashi Eye Hospital(Fukuoka)


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 27 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

Completed

Date of protocol fixation

2012 Year 11 Month 30 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 10 Day

Last follow-up date

2013 Year 12 Month 07 Day

Date of closure to data entry

2013 Year 12 Month 09 Day

Date trial data considered complete

2013 Year 12 Month 09 Day

Date analysis concluded

2013 Year 12 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 03 Month 27 Day

Last modified on

2014 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015808


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name