The Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Cataract
Both
Cataract
Trial Information
The Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans
Inclusion Criteria:
- Age related/senile bilateral cataract
- Eligible for phaco-emulsification on both eyes
Exclusion Criteria:
- Known eye disease other than cataract.
- Known systemic disease, which may affect the retina (untreated hypertension, DM etc.)
- Known systemic disease, which may affect the lens.
- Known psychiatric disease.
- Known sleep or circadian rhythm disorder, not caused by lowered blue light
transmission by the lens.
- Per- and post operative complications
- Use of drugs that may affect the sleep.
For a subpopulation also:
- Poor cooperation.
- Severe refraction abnormalities.
- Previous eye surgery
- Nystagmus
- Congenital or acquired abnormalities of: eye lids and eye area, cornea or iris.
- Use of medicine that may affect the pupillary response.
- Use of drugs that may affect the pupillary response.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Pupillary response to blue light
Outcome Description:
Measurement of the consensual light response to red (630 nm) and blue (470 nm)
Outcome Time Frame:
1 year/1month
Safety Issue:
No
Principal Investigator
Adam E Brøndsted, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Glostrup UH
Authority:
Denmark: Ethics Committee
Study ID:
CIRCAT
NCT ID:
NCT01686308
Start Date:
February 2011
Completion Date:
December 2014
Related Keywords:
- Cataract
- cataract
- circadian rhythm
- pupillometry
- blue light transmission
- questionnaire
- sleep
- Cataract
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