Plain English Summary
Background and study aims
The aim of this study is to detect the changes in pupil size following cataract surgery.
Who can participate?
Adults aged 48 to 81 and undergoing cataract surgery.
What does the study involve?
All patients will receive the same type of intraocular lens. Measurements will be made five minutes after the operation and then one month after the operation.
What are the possible benefits and risks of participating?
The benefit is better visual acuity after the operation. The risk is complication after standard cataract surgery.
Where is the study run from?
Uskudar University, Istambul (Turkey).
When is study starting and how long is it expected to run for?
From December 2014 to February 2015
Who is funding the study?
Uskudar University and GMMA Haydarpasa Training Hospital
Who is the main contact?
Dr. Yildiray Yildirim
yyildirim@gata.edu.tr
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Changes in pupil size following phacoemulsification surgery: a prospective cohort study
Acronym
Study hypothesis
The pupil size is important in appropriate cases in whom the combination with phacoemulsification and multifocal intra occular lenses (IOL) implantation would be performed. This is because postoperative visual disturbances may be directly related to the pupil size. Therefore, pupil size assessment of the patients who are to undergo implantation of a multifocal lens is important.
Ethics approval
Clinical Research Ethics Committee of Haydarpasa Numune Training and Research Hospital, Istanbul. 22/12/2014, HNEAH-KAEK 2014/92
Study design
Prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Changes in pupil size developing after phacoemulsification surgery
Intervention
All patients will have phacoemulsification surgery and implantation of the same type of intraocular lens. Pupil measurements will be made after each patient waited in a dark room for 5 minutes preoperatively and will be repeated one month after the operation.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Preoperative and postoperative pupil size changes
Secondary outcome measures
Optic aberrations
Overall trial start date
25/12/2014
Overall trial end date
05/02/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1- Male and female patients aged between 48 and 81
2- Patients with cataracts
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
49 patients
Participant exclusion criteria
1- Patients who have a history of ocular trauma, uveitis, optic neuropathy or anisocoria and also have other accompanying serious ocular diseases except cataract
2- Patients who have a complicated phacoemulsification surgery
Recruitment start date
25/12/2014
Recruitment end date
05/01/2015
Locations
Countries of recruitment
Turkey
Trial participating centre
Uskudar University
Istanbul
34000
Turkey
Trial participating centre
GMMA Haydarpasa Training Hospital
Istanbul
34000
Turkey
Sponsor information
Organisation
Uskudar University
Sponsor details
Altunizade District Haluk Turksoy Street. No:14
Istanbul
34662
Turkey
+90 216 400 22 22
info@uskudar.edu.tr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Uskudar University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication of study results in peer-reviewed journal in 2015.
Intention to publish date
31/03/2015
Participant level data
Available on request
Basic results (scientific)
Publication list