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
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
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
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
