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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013526
Receipt No. 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

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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
Institute Hayashi Eye Hospital
Institute
Department

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
URL(English) https://upload.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


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