Condition category
Eye Diseases
Date applied
07/02/2015
Date assigned
23/06/2015
Last edited
19/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr. Yildiray Yildirim

ORCID ID

Contact details

GMMA Haydarpasa Training Hospital
Department of Ophthalmology
Istanbul
34000
Turkey

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes