Changes in pupil size following phacoemulsification surgery

ISRCTN	ISRCTN15538746
DOI	https://doi.org/10.1186/ISRCTN15538746
Secondary identifying numbers	N/A

Submission date: 07/02/2015
Registration date: 23/06/2015
Last edited: 19/06/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr. Yildiray Yildirim
Scientific

GMMA Haydarpasa Training Hospital, Department of Ophthalmology
Istanbul
34000
Türkiye

Study information

Study design	Prospective cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Changes in pupil size following phacoemulsification surgery: a prospective cohort study
Study objectives	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(s)	Clinical Research Ethics Committee of Haydarpasa Numune Training and Research Hospital, Istanbul. 22/12/2014, HNEAH-KAEK 2014/92
Health condition(s) or problem(s) studied	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
Primary outcome measure	Preoperative and postoperative pupil size changes
Secondary outcome measures	Optic aberrations
Overall study start date	25/12/2014
Completion date	05/02/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	49 patients
Key inclusion criteria	1- Male and female patients aged between 48 and 81 2- Patients with cataracts
Key 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
Date of first enrolment	25/12/2014
Date of final enrolment	05/01/2015

Locations

Countries of recruitment

Türkiye

Study participating centres

Uskudar University

Istanbul
34000
Türkiye

GMMA Haydarpasa Training Hospital

Istanbul
34000
Türkiye

Sponsor information

Uskudar University
Hospital/treatment centre

Altunizade District Haluk Turksoy Street. No:14
Istanbul
34662
Türkiye

Phone	+90 216 400 22 22
Email	info@uskudar.edu.tr
"ROR"	https://ror.org/02dzjmc73

Funders

Funder type

University/education

Uskudar University

No information available

Results and Publications

Intention to publish date	31/03/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Publication of study results in peer-reviewed journal in 2015.
IPD sharing plan