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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028385 |
Receipt No. | R000032490 |
Scientific Title | Surgically induced changes in astigmatism and shape of total and posterior cornea after nasal versus temporal clear corneal incision (CCI) cataract surgery: a prospective randomized clinical study. |
Date of disclosure of the study information | 2017/07/26 |
Last modified on | 2018/06/22 |
Basic information | ||
Public title | Surgically induced changes in astigmatism and shape of total and posterior cornea after nasal versus temporal clear corneal incision (CCI) cataract surgery: a prospective randomized clinical study. | |
Acronym | Corneal shape changes of total and posterior corneas after nasal versus temporal clear corneal incisions. | |
Scientific Title | Surgically induced changes in astigmatism and shape of total and posterior cornea after nasal versus temporal clear corneal incision (CCI) cataract surgery: a prospective randomized clinical study. | |
Scientific Title:Acronym | Corneal shape changes of total and posterior corneas after nasal versus temporal clear corneal incisions. | |
Region |
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Condition | ||
Condition | Cataract | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this study is to compare surgically induced astigmatism (SIA) and shape changes of total and posterior cornea between eyes that underwent nasal clear corneal incisions (CCI) and eyes that underwent temporal CCI in cataract surgery. |
Basic objectives2 | Bio-equivalence |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Patients are to undergo examinations at 2 days and at 2, 4, and 8 weeks after surgery.
1) Corneal astigmatism of anterior and posterior corneas (simulated K value of a videokeratography system; Tomey TMS-5) 2) Corneal shape changes of anterior and posterior cornea (average of difference map of TMS-5) |
Key secondary outcomes | 3) Irregular astigmatism components (asymmetry and higher-order irregularity components)
4) Ocular higher order aberrations (HOAs) 5) Visual acuity and refractive status 6) Wound length and width 7) Pupil diameter 8) Surgical factors |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -but 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 |
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Interventions/Control_1 | One hundred left eyes of 100 patients with with-the-rule astigmatism of 0.5 D or less were randomly assigned to one of the two groups. | |
Interventions/Control_2 | 50 eyes were to undergo nasal CCI and 50 eyes were to undergo temporal CCI. | |
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Interventions/Control_4 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | One hundred left eyes of 100 patients with with-the-rule astigmatism of 0.5 D or less. | |||
Key exclusion criteria | Exclusion criteria were 1) eyes with any pathology of cornea, optic nerve, and macula; 2) eyes with lens nucleus harder than grade 4 according to the Lens Opacities Classification System III; 3) eyes with a poor mydriasis less than 4.5 mm; 4) eyes with possible zonular weakness, 5) eyes with pseudoexfoliation; 6) eyes with prior history of ocular surgery and inflammation, 7) patients with diabetes; 8) patients who were referred from other hospitals, and 9) patients who had been enrolled in other studies | |||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Hayashi Eye Hospital |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032490 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |