The Effect of Cataract on Photoentrainment of the Circadi... | NCT01686308

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

NCT01686308

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

Feb 10, 2015Estimated

Enrollment

76Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

Yellow Intra Ocular Lens (IOL)
Conventional Intra Ocular Lens (IOL)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Nov 30, 2011

First Submission Date that Met QC Criteria

Sep 17, 2012

First Posted Date

Sep 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2015

Last Update Posted Date

Feb 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Yellow Intra Ocular Lens (IOL)	Procedure	Standard operation with blue light filter Yellow IOL implantation	Yellow Intra Ocular Lens (IOL)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pupillary response to blue light	Measurement of the consensual light response to red (630 nm) and blue (470 nm)	1 year/1month

Secondary Outcomes

Measure	Description	Time Frame
Questionnaire	Pittsburgh Sleep Quality Index and the Morningness Eveningness Questionnaire	1year/1month
Questionnaire	Morningness-eveningness questionnaire

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam E Brøndsted, MD	Glostrup UH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glostrup University Hospital		Glostrup Municipality		DK-2600	Denmark

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases