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The Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans (CIRCAT)

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Yellow Intra Ocular Lens (IOL)
Conventional Intra Ocular Lens (IOL)
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract, circadian rhythm, pupillometry, blue light transmission, questionnaire, sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Glostrup University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Intra Ocular Lens (IOL)

Yellow Intra Ocular Lens (IOL)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Questionnaire
Pittsburgh Sleep Quality Index and the Morningness Eveningness Questionnaire
Questionnaire
Morningness-eveningness questionnaire
Melatonin day variety analysis
Salivary samples collected with 4 hour interval during 24 hours. Analyzed for melatonin concentration with Radio Immuno Assay (RIA).
Actigraphy
Activity measured during 7 days and 7 nights with the Spectrum Actiwatch, Respironics, Philips

Full Information

First Posted
November 30, 2011
Last Updated
February 9, 2015
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01686308
Brief Title
The Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans
Acronym
CIRCAT
Official Title
The Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract, circadian rhythm, pupillometry, blue light transmission, questionnaire, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Intra Ocular Lens (IOL)
Arm Type
Active Comparator
Arm Description
Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation.
Arm Title
Yellow Intra Ocular Lens (IOL)
Arm Type
Experimental
Arm Description
Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation.
Intervention Type
Procedure
Intervention Name(s)
Yellow Intra Ocular Lens (IOL)
Intervention Description
Standard operation with blue light filter Yellow IOL implantation
Intervention Type
Procedure
Intervention Name(s)
Conventional Intra Ocular Lens (IOL)
Intervention Description
Standard operation with conventional IOL implantation
Primary Outcome Measure Information:
Title
Pupillary response to blue light
Description
Measurement of the consensual light response to red (630 nm) and blue (470 nm)
Time Frame
1 year/1month
Secondary Outcome Measure Information:
Title
Questionnaire
Description
Pittsburgh Sleep Quality Index and the Morningness Eveningness Questionnaire
Time Frame
1year/1month
Title
Questionnaire
Description
Morningness-eveningness questionnaire
Time Frame
1 year/1 month
Title
Melatonin day variety analysis
Description
Salivary samples collected with 4 hour interval during 24 hours. Analyzed for melatonin concentration with Radio Immuno Assay (RIA).
Time Frame
1year/1month
Title
Actigraphy
Description
Activity measured during 7 days and 7 nights with the Spectrum Actiwatch, Respironics, Philips
Time Frame
1year/1month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam E Brøndsted, MD
Organizational Affiliation
Glostrup UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glostrup University Hospital
City
Glostrup
ZIP/Postal Code
DK-2600
Country
Denmark

12. IPD Sharing Statement

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

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