A randomized controlled trial to determine the long-term influence of clear intra ocular lens (IOL) and yellow IOL with cataract surgery on circadian biological rhythm and related health outcomes

A randomized controlled trial to determine the long-term influence of clear intra ocular lens (IOL) and yellow IOL with cataract surgery on circadian biological rhythm and related health outcomes - The CLOCK-IOL Color Study Cataract Surgery and Circadian Biological Rhythm among Japanese Older People with Cataract in Nara, Kansai Region: Influence of Intra Ocular Lens Implantation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014680

Enrollment

1000

Registered

2014-07-28

Start date

2014-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Interventions

Yellow IOL group Phacoemulsification and yellow IOL implantation(SN60AT,SN60WF(Alcon)). Clear IOL group Phacoemulsification and clear IOL implantation (SA60AT(Alcon)).

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
All-cause mortality rate Incidence rate of age related macular degeneration	—

Secondary

Measure	Time frame
1 Frequency of Diseases 1) Prevalence of depression insomnia obesity dyslipidemia and diabetes 2) Incidence rate of cancer, stroke and ischemic heart disease 2 Ophthalmic outcomes 1) Retinal and Choroidal thickness(OCT: optical coherence tomography) 2) Macular pigment density 3) Aberrations(spherical and coma) 4) Contrast sensitivity 5) Accommodation 6) Subjective visual function (The National Eye Institute Visual Function Questionnaire: NEI VFQ-25) 7) Post Illumination Pupil Response (PIPR) 3 Glucose-lipid metabolism outcomes 1) FPG HbA1c 2) TG T-chol LDL chol and HDL chol BMI(Body Mass Index) Abdominal circumference 4 Depression Sleep Outcomes 1) Depressive symptoms (Geriatric Depression Scale:GDS) 2) Objective sleep quality(measured using actigrapgh) 3) Subjective sleep quality(Pittsburgh Sleep Quality Index:PSQI) 4) Sleepiness(Epworth Sleepiness Scale:ESS) 5 Circadian rhythm outcomes 1) 6-sulfatoxymelatonin(aMT6-s)in a morning spot urine sample 2) Circadian activity rhythm(actigraph) 3) Distal- proximal gradient of skin temperatures (wrist-abdominal) 4) Morningness-Eveningness Questionnaire (MEQ) 5) Munich ChronoType Questionniare	—

Measure

Time frame

1 Frequency of Diseases 1) Prevalence of depression insomnia obesity dyslipidemia and diabetes 2) Incidence rate of cancer, stroke and ischemic heart disease 2 Ophthalmic outcomes 1) Retinal and Choroidal thickness(OCT: optical coherence tomography) 2) Macular pigment density 3) Aberrations(spherical and coma) 4) Contrast sensitivity 5) Accommodation 6) Subjective visual function (The National Eye Institute Visual Function Questionnaire: NEI VFQ-25) 7) Post Illumination Pupil Response (PIPR) 3 Glucose-lipid metabolism outcomes 1) FPG HbA1c 2) TG T-chol LDL chol and HDL chol BMI(Body Mass Index) Abdominal circumference 4 Depression Sleep Outcomes 1) Depressive symptoms (Geriatric Depression Scale:GDS) 2) Objective sleep quality(measured using actigrapgh) 3) Subjective sleep quality(Pittsburgh Sleep Quality Index:PSQI) 4) Sleepiness(Epworth Sleepiness Scale:ESS) 5 Circadian rhythm outcomes 1) 6-sulfatoxymelatonin(aMT6-s)in a morning spot urine sample 2) Circadian activity rhythm(actigraph) 3) Distal- proximal gradient of skin temperatures (wrist-abdominal) 4) Morningness-Eveningness Questionnaire (MEQ) 5) Munich ChronoType Questionniare

—

Countries

Japan

Contacts

Public ContactTomo Nishi

Nara Medical University School of Medicine Department of Ophthalmology

tomon@naramed-u.ac.jp0744-29-8884

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026