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The Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans


N/A
18 Years
N/A
Open (Enrolling)
Both
Cataract

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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 Br√łndsted, 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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