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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014559

Enrollment

1000

Registered

2014-07-15

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

Cataract surgery with implantation of intraocular lens Control

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactKeigo Saeki

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

saekik@naramed-u.ac.jp0744-29-8841

Outcome results

None listed

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