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

NCT ID: NCT01686308

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional Intra Ocular Lens (IOL)

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

Group Type: ACTIVE_COMPARATOR

Conventional Intra Ocular Lens (IOL)

Intervention Type: PROCEDURE

Standard operation with conventional IOL implantation

Yellow Intra Ocular Lens (IOL)

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

Group Type: EXPERIMENTAL

Yellow Intra Ocular Lens (IOL)

Intervention Type: PROCEDURE

Standard operation with blue light filter Yellow IOL implantation

Interventions

Yellow Intra Ocular Lens (IOL)

Standard operation with blue light filter Yellow IOL implantation

Intervention Type: PROCEDURE

Conventional Intra Ocular Lens (IOL)

Standard operation with conventional IOL implantation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Adam Elias Brøndsted

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam E Brøndsted, MD

Role: PRINCIPAL_INVESTIGATOR

Glostrup UH

Locations

Glostrup University Hospital

Glostrup Municipality, , Denmark

Countries

Denmark

Other Identifiers

CIRCAT

Identifier Type: -

Identifier Source: org_study_id