UMIN-CTR Clinical Trial

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

Japan

Condition

Cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

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.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

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

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

Email

hayashi-ken@hayashi.or.jp

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

Email

hayashi-ken@hayashi.or.jp

Institute

Hayashi Eye Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

林眼科病院（福岡県）/ Hayashi Eye Hospital(Fukuoka)

Date of disclosure of the study information

2017

Year

07

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

10

Month

26

Day

Date of IRB

Anticipated trial start date

2016

Year

11

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

07

Month

26

Day

Last modified on

2018

Year

06

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032490