Changes in pupil size following phacoemulsification surgery
| ISRCTN | ISRCTN15538746 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15538746 |
| Protocol serial number | N/A |
| Sponsor | Uskudar University |
| Funder | Uskudar University |
- 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
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
Scientific
GMMA Haydarpasa Training Hospital, Department of Ophthalmology
Istanbul
34000
Türkiye
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant 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(s) |
Preoperative and postoperative pupil size changes |
| Key secondary outcome measure(s) |
Optic aberrations |
| Completion date | 05/02/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 49 |
| 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
34000
Türkiye
34000
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
