UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054492 |
|---|---|
| Receipt number | R000062242 |
| Scientific Title | Temporal versus superior clear corneal incision for eyes with oblique astigmatism |
| Date of disclosure of the study information | 2024/05/27 |
| Last modified on | 2024/10/04 09:55:14 |
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Basic information
Public title
Temporal versus superior clear corneal incision for eyes with oblique astigmatism
Acronym
Temporal versus superior incision for eyes with oblique astigmatism
Scientific Title
Temporal versus superior clear corneal incision for eyes with oblique astigmatism
Scientific Title:Acronym
Temporal versus superior incision for eyes with oblique astigmatism
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to compare the amount of the total corneal astigmatism between eyes that underwent temporal (TCI) or superior corneal incision (SCI) for eyes with near against-the-rule and near with-the-rule oblique astigmatism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of the total corneal astigmatism determined by the simulated K value of the corneal topography before surgery and at 2 days, and at 2, 4, 8 weeks after surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
This study was conducted at the Hayashi Eye Hospital, Fukuoka, Japan, between April 4, 2021, and September 24, 2023, separately in 120 eyes with near ATR oblique astigmatism (near ATR category) and in 120 eyes with near WTR oblique astigmatism (near WTR category). The eyes were randomly assigned to 1 of 2 groups. One group comprised 60 eyes of 60 patients who were scheduled to undergo a 2.4-mm temporal clear corneal incision (temporal incision group).
Interventions/Control_2
The other group comprised 60 eyes of 60 patients who were scheduled to undergo a 2.4-mm superior corneal incision (superior incision group).
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
Major inclusion criteria were eyes with oblique corneal astigmatism more than 0.5 D that were scheduled for undergoing phacoemulsification with hydrophobic acrylic IOL implantation.
Key exclusion criteria
Exclusion criteria were: 1) pathology of the cornea, macula, or optic nerve, 2) severe opaque media other than cataract, 3) moderate to severe dry eye, 4) blepharitis or Meibomian gland dysfunction, 5) diabetes mellitus, 6) history of ocular surgery or inflammation, 7) difficulty to undergo examination, and 8) patient refusal.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Hayashi |
Organization
Hayashi Eye Hospital
Division name
Department of Ophthalmology
Zip code
8120011
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 | Ken |
| Middle name | |
| Last name | Hayashi |
Organization
Hayashi Eye Hospital
Division name
Department of Ophthalmology
Zip code
8120011
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
Self funding.
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
Institutional Review Board of Hayashi Eye Hospital
Address
4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan
Tel
092-431-1680
mihara-seiya@hayashi.or.jp
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
| 2024 | Year | 05 | 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
240
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
| 2021 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 27 | Day |
Last modified on
| 2024 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062242
