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

NCT01686308 | Completed DMC

• 1 other identifier: CIRCAT
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Cataract is globally the most common cause of blindness and in Denmark the operation with - 50.000 treatments per year - is the most common eye operation. The cause of cataract is growth and denaturation of the lens proteins. This leads to an increased absorption of blue light and increased light scatter. This may affect newly discovered cells in the retina that are involved in the regulation of the circadian rhythm. When the internal circadian rhythm is not synchronized with the external day and night a phase-shift occurs. Most people know of this discomfort as jet-lag, but the consequences may be much more severe such as heighten risk of cancer and cardiovascular disease. The goal of this project is to study how the circadian regulating cells of the retina is affected by cataract and by the operation. Cataract patients are studied before and after the operation with questionnaires, hormone and activity measurements and with a specialized pupil measurement that measures the indirect response of the circadian regulating cells to blue light. Results from this study aim to shed light on the regulatory mechanisms of the eye on the circadian rhythm and how these are affected by cataract. Furthermore, choice of intraocular lens is evaluated. This may have impact on clinical practise especially with regard to choice of intraocular lens and widened indications for cataract surgery.

Conditions

Cataract

Keywords

cataract; circadian rhythm; pupillometry; blue light transmission; questionnaire; sleep

Outcome Measures

Primary Outcomes (1)

• Pupillary response to blue light

  Measurement of the consensual light response to red (630 nm) and blue (470 nm)

  1 year/1month

Secondary Outcomes (4)

• Questionnaire

  1year/1month

• Questionnaire

  1 year/1 month

• Melatonin day variety analysis

  1year/1month

• Actigraphy

  1year/1month

Study Arms (2)

Conventional Intra Ocular Lens (IOL)

ACTIVE COMPARATOR

Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation.

Procedure: Conventional Intra Ocular Lens (IOL)

Yellow Intra Ocular Lens (IOL)

EXPERIMENTAL

Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation.

Procedure: Yellow Intra Ocular Lens (IOL)

Interventions

Yellow Intra Ocular Lens (IOL) PROCEDURE

Standard operation with blue light filter Yellow IOL implantation

Yellow Intra Ocular Lens (IOL)

Conventional Intra Ocular Lens (IOL) PROCEDURE

Standard operation with conventional IOL implantation

Conventional Intra Ocular Lens (IOL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age related/senile bilateral cataract
• Eligible for phaco-emulsification on both eyes

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Glostrup University Hospital

Glostrup Municipality, DK-2600, Denmark

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Adam E Brøndsted, MD

  Glostrup UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: September 18, 2012
• Study Start: February 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

DK (1)