Association between cataract surgery and type of implanted intraocular lens with sleep quality
Organizational Data
- DRKS-ID:
- DRKS00008728
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-06-05
- Last update in DRKS:
- 2017-10-19
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
In this trial, changes in sleep quality after cataract surgery will be noted. It is considered that the blue light affects the circadian rhythm of sleep and wakefulness, and that cataract acts as a filter of blue light and thus reduces the quality of sleep. Removing a cataract should increase the passage of light to the retina and thereby improve the quality of sleep. The quality of sleep will be examined using the "Pittsburgh sleep quality index" questionnaire before and after cataract surgery. It is a questionnaire that measures sleep quality in the last month using 18 questions. The questionnaire is filled out at least one month before and two months after surgery to avoid the stress that could affect the results.
Brief summary in scientific language
Sleep pattern is regulated via retinohypothalamic tract by stimulation of retinal ganglion cells, primarily with short wavelength light (blue light). With aging, the natural human lens opacifies and prevents passage of light to retina, and that may influence entrainment of circadian rhythms. Intraocular lenses with blue light filter were developed in order to prevent adverse effects of blue light to retina. In this study, quality of sleep before and after cataract surgery will be qualitatively and quantitatively measured using validated "Pittsburgh sleep quality index" questionnaire. The results will help determine that opaque human lens is partially responsible for poor sleep quality in elderly population, that the cataract surgery effectively improves sleep quality and determine whether there is difference in improving of sleep quality between patients with implantation of blue-light-filtering lens and ones with implantation of conventional intraocular lens (UV filter only).
Health condition or problem studied
- ICD10:
- h25 - Senile cataract
- ICD10:
- G47 - Sleep disorders
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Phacoemulsification of cataract and implantation of blue-light-filtering intraocular lens
- Arm 2:
- Phacoemulsification of cataract and implantation of conventional (UV filter only) intraocular lens
Endpoints
- Primary outcome:
- Sleep quality, measured with PSQI one month before and 2 months after cataract surgery
- Secondary outcome:
- No Entry
Study Design
- Purpose:
- Other
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Data analyst
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Croatia
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Department of Ophthalmology Zagreb
Recruitment period and number of participants
- Planned study start date:
- 2015-08-02
- Actual study start date:
- 2015-08-10
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2017-08-10
- Target Sample Size:
- 220
- Final Sample Size:
- 198
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 60 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- having senile cataract; no usage of psychotropic drugs (due to impaired architectonics of sleep); no verified sleep disorders such as restless legs, sleep apnea, work in shifts; no previous eye surgeries; no diseases and disorders of the retina; having both eyes; no blurriness of other optical media; no eyelid ptosis; no end-stage glaucoma.
Exclusion Criteria
complications of cataract surgery; a change of type or dose of previously taken medications; starting of taking a new medication.
Addresses
Primary Sponsor
- Address:
- Department of Ophthalmology, University hospital centre ZagrebIvan ŠkegroKišpatićeva 1210000 ZagrebCroatia
- Telephone:
- +385 95 9015 642
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Department of Ophthalmology, University hospital centre ZagrebIvan ŠkegroKišpatićeva 1210000 ZagrebCroatia
- Telephone:
- +385 95 9015 642
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Department of Ophthalmology, University hospital centre ZagrebIvan ŠkegroKišpatićeva 1210000 ZagrebCroatia
- Telephone:
- +385 95 9015 642
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Department of Ophthalmology, University hospital centre ZagrebIvan ŠkegroKišpatićeva 1210000 ZagrebCroatia
- Telephone:
- +385 95 9015 642
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Department of Ophthalmology, University hospital centre ZagrebKišpatićeva 1210000 ZagrebCroatia
- Telephone:
- +385 95 9015 642
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- University hospital Dubrava, Department of Radiology [Ethics Committee of University hospital Centre Zagreb; Ethics Committee of University of Zagreb School of Medicine ]Prof. Boris BrkljačićAvenija Gojka Šuška 610000 ZagrebCroatia
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.mef.unizg.hr/druga.php?grupa=050600000000
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-02-02
- Ethics committee number:
- 641-01/15-02/01
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-07-08
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry