UMIN-CTR Clinical Trial

Public title

A randomized controlled study about the influence of cataract surgery with spherical intra ocular lens (IOL) and aspherical IOL on pseudoaccommodation and visual function among elderly people

Acronym

A randomized controlled study about the influence of spherical intra ocular lens (IOL) and aspherical IOL with cataract surgery on pseudoaccmmodation and visual function among elderly people

Scientific Title

A randomized controlled study about the influence of cataract surgery with spherical intra ocular lens (IOL) and aspherical IOL on pseudoaccommodation and visual function among elderly people

Scientific Title:Acronym

A randomized controlled study about the influence of spherical intra ocular lens (IOL) and aspherical IOL with cataract surgery on pseudoaccmmodation and visual function among elderly people

Region

Japan

Condition

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We compare the pseudoaccommodation and subjective visual function between spherical IOL group and aspherical IOL group after cataract surgery.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Pseudoaccommodation
Japanese version of the National Eye Institute Visual Function Questionnaire (NEI VFQ-25).

Key secondary outcomes

Aberration(Spherical, Coma)
Contrast sensitivity
Ophthalmological examinations(visual acuity,intraocular pressure, axial length,cornea endothelial cell,pupil diameter)
Retinal and Choroidal thickness
Retinal disease
Visual field
Subjective sleep(PSQI: Pittsburgh Sleep Quality Index)
Depressive symptoms(GDS: Geriatic Depression Scale)
Physical activity(Actigraph)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Spherical IOL group
Phacoemulsification and spherical IOL implantation(SN60AT(Alcon)).

Interventions/Control_2

Aspherical IOL group
Phacoemulsification and aspherical IOL implantation (SN60WF(Alcon)).

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

60

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)patients scheduled for the first cataract
surgery
2)age <=60 years
3)cataract with <=grade 2 nuclear
opacification according to LOCS III

Key exclusion criteria

1)severe mental illness and dementia
2)severe corneal opacity
3)glaucoma with visual field deficit of at least
MD>14dB (Humphrey Perimeter)
4)vitreous haemorrhage
5)proliferative diabetic retinopathy
6)macular edema
7)age-related macular degeneration
8)patients needing emergent cataract surgery
9)patients needing combined cataract and
glaucoma surgery or combined cataract
surgery and vitrectomy

Target sample size

500

Name of lead principal investigator

1st name	Tomo
Middle name
Last name	Nishi

Organization

Nara Medical University School of Medicine

Division name

Department of Ophthalmology

Zip code

6348522

Address

840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521

TEL

0744-29-8884

Email

ogata@naramed-u.ac.jp

Name of contact person

1st name	Tomo
Middle name
Last name	Nishi

Organization

Nara Medical University School of Medicine

Division name

Department of Ophthalmology

Zip code

6348522

Address

840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521

TEL

0744-29-8884

Homepage URL

Email

tomon@naramed-u.ac.jp

Institute

Department of Ophthalmology
Nara Medical University School of Medicine

Institute

Department

Personal name

Organization

Nara Medical University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nara Medical University Certified Review Board

Address

840 Shijo cho Kashihara, Nara

Tel

0744-22-3051

Email

ychiken@naramed-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

奈良県立医科大学付属病院
Nara Medical University Hospital

Date of disclosure of the study information

2014

Year

07

Month

28

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

Open public recruiting

Date of protocol fixation

2014

Year

07

Month

15

Day

Date of IRB

Anticipated trial start date

2014

Year

07

Month

28

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

07

Month

28

Day

Last modified on

2024

Year

04

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017074