UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013909 |
|---|---|
| Receipt number | R000016214 |
| Scientific Title | Randomized comparison of intraocular pressure (IOP) and corneal shape between eyes after transconjunctival single-plane scleracorneal incision and clear corneal incision cataract surgery |
| Date of disclosure of the study information | 2014/05/08 |
| Last modified on | 2016/08/05 17:07:20 |
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Basic information
Public title
Randomized comparison of intraocular pressure (IOP) and corneal shape between eyes after transconjunctival single-plane scleracorneal incision and clear corneal incision cataract surgery
Acronym
IOP and corneal shape between eyes with single-plane scleracorneal and corneal incision cataract surgery
Scientific Title
Randomized comparison of intraocular pressure (IOP) and corneal shape between eyes after transconjunctival single-plane scleracorneal incision and clear corneal incision cataract surgery
Scientific Title:Acronym
IOP and corneal shape between eyes with single-plane scleracorneal and corneal incision cataract surgery
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, surgeons who perform trans- conjunctival single-plane scleracorneal incision cataract surgery are increasing. The purpose of this study was to compare the immediate change in IOP and wound structure, and corneal shape changes between eyes with the single-plane scleracorneal incision and clear corneal incision.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A) Changes in IOP and wound structure immediately after cataract surrgery
1) Longitudinal changes in IOP using rebound tonometer after cataract surgery preoperatively, at the conclusion of surgery; and at 15, 30, 60, and 120 minutes, and 24 hours postoperatively.
2) Seidel test at 30 minutes postoperatively
3) Wound structure at 30 minutes after surgery using the anterior segment-optical coherence tomography (AS-OCT)
B) Changes in corneal astigmatism and shape preoperatively and at 2, 14, 30, and 60 days postoperatively
4) Corneal astigmatism and surgically induced astigmatism determined using keratometer
5) Corneal shape change determined using corneal topography
5-1) Averaged difference map
5-2) Irregular corneal astigmatism determined by Fourier analysis
Key secondary outcomes
6) Corneal endothelial cell counts and central corneal thickness
7) Visual acuity
8) Refractive status (spherical power, refractive cylinder, manifest spherical equivalent power)
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 transconjuctival single-plane sclerocorneal 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 contralateral 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 17, 2014. 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 single-plane sclerocorneal incision 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 single-plane sclerocorneal incision 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, Japan
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, Japan
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）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 08 | 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
| 2013 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 08 | Day |
Last modified on
| 2016 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016214
