UMIN-CTR Clinical Trial

Public title

A randomized controlled trial to determine the short-term influence of cataract surgery on circadian biological rhythm and related health outcomes

Acronym

The CLOCK-IOL Study
Cataract Surgery and Circadian Biological Rhythm among Japanese Older People with Cataract in Nara, Kansai Region: Influence of Intra Ocular Lens Implantation

Scientific Title

A randomized controlled trial to determine the short-term influence of cataract surgery on circadian biological rhythm and related health outcomes

Scientific Title:Acronym

The CLOCK-IOL Study
Cataract Surgery and Circadian Biological Rhythm among Japanese Older People with Cataract in Nara, Kansai Region: Influence of Intra Ocular Lens Implantation

Region

Japan

Condition

Cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine whether cataract surgery modifies the internal biological rhythm and improves its related health outcomes such as depression, sleep quality, body mass regulation and glucose/lipid metabolism at 3 months after surgery.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

Depressive sympoms assessed using the short version of geriatric depression scale (GDS-15)

Key secondary outcomes

1 Sleep Outcomes
1) Objective sleep quality (measured using actigrapgh)
2) Subjective sleep quality (Pittsburgh Sleep Quality Index :PSQI)
3) Sleepiness (Epworth Sleepiness Scale :ESS)

2 Glucose-lipid metabolism outcomes
1) FPG, HbA1c
2) TG, T-chol. LDL/HDL cholesterol
3) BMI(Body Mass Index), Abdominal circumference

3 Ophthalmic outcomes
1) Visual accuity
2) Subjective visual function (The National Eye Institute Visual Function Questionnaire:NEI VFQ-25)

4 Circadian rhythm outcomes
1)6-sulfatoxymelatonin (aMT6-s) in a morning spot urine sample
2)Circadian activity rhythm (actigraph)
3)Wrist temperature
4)Post Illumination Pupil Response (PIPR)
5)Morningness-Eveningness Questionnaire (MEQ)
6)Munich ChronoType Questionniare

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Cataract surgery with implantation of intraocular lens

Interventions/Control_2

Control

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

1000

Name of lead principal investigator

1st name	Keigo
Middle name
Last name	Saeki

Organization

Nara Medical University School of Medicine

Division name

Department of Community Health and Epidemiology

Zip code

634-8521

Address

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

TEL

0744-29-8841

Email

saekik@naramed-u.ac.jp

Name of contact person

1st name	Keigo
Middle name
Last name	Saeki

Organization

Nara Medical University School of Medicine

Division name

Department of Community Health and Epidemiology

Zip code

634-8521

Address

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

TEL

0744-29-8841

Homepage URL

Email

saekik@naramed-u.ac.jp

Institute

Nara Medical University School of Medicine, Department of Community Health and Epidemiology

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

Institutional Review Board of Nara Medical University

Address

Shijo-cho 840, Kashihara-shi, 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

15

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

169

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

Main results already published

Date of protocol fixation

2014

Year

07

Month

15

Day

Date of IRB

2014

Year

03

Month

31

Day

Anticipated trial start date

2014

Year

07

Month

28

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

07

Month

15

Day

Last modified on

2021

Year

07

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016916