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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00008728 |
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Date of registration:
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05/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Association between cataract surgery and type of implanted intraocular lens with sleep quality
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Scientific title:
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Association between cataract surgery and type of implanted intraocular lens with sleep quality |
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Date of first enrolment:
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10/08/2015 |
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Target sample size:
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220 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00008728 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: other
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Phase:
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N/A
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Ivan
Škegro |
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Address:
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Kišpaticeva 12
10000
Zagreb
Croatia |
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Telephone:
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+385 95 9015 642 |
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Email:
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ivanskegro@yahoo.com |
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Affiliation:
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Department of Ophthalmology, University hospital centre Zagreb |
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Name:
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Ivan
Škegro |
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Address:
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Kišpaticeva 12
10000
Zagreb
Croatia |
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Telephone:
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+385 95 9015 642 |
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Email:
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ivanskegro@yahoo.com |
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Affiliation:
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Department of Ophthalmology, University hospital centre Zagreb |
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Key inclusion & exclusion criteria
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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.
Age minimum:
60 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Senile cataract
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h25
G47
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Sleep disorders
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Intervention(s)
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Group 1: Phacoemulsification of cataract and implantation of blue-light-filtering intraocular lens
Group 2: Phacoemulsification of cataract and implantation of conventional (UV filter only) intraocular lens
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Primary Outcome(s)
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Sleep quality, measured with PSQI one month before and 2 months after cataract surgery
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Secondary ID(s)
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U1111-1170-8477
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Source(s) of Monetary Support
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Department of Ophthalmology, University hospital centre Zagreb
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Ethics review
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Status: Approved
Approval date: 08/07/2014
Contact:
University hospital Dubrava, Department of Radiology [Ethics Committee of University hospital Centre Zagreb;
Ethics Committee of University of Zagreb
School of Medicine ]
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