Comparing the effect of different eye drop instillation techniques
| ISRCTN | ISRCTN65345295 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65345295 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2-2018 |
| Sponsor | University of Kocaeli |
| Funder | Investigator initiated and funded |
- Submission date
- 02/08/2021
- Registration date
- 10/08/2021
- Last edited
- 09/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Eye drops are commonly used in the treatment of eye conditions. They are used for the prevention or treatment of infective or inflammatory disorders, to prevent and decrease the complaints of dry eye, and for eye examinations.
Failure to properly administrate eye drops can prolong the condition, clinical outcomes can be negatively affected and may present a risk to the patients’ vision.
The aim of this study is to investigate whether instillation of cyclopentolate eye drops to the corner of the eye and immediately opening the eyelid or opening of the lids in few seconds after instillation would make any difference on dilating the pupil and feeling of irritation while also comparing the traditional method with these two methods.
Who can participate?
Patients who require eye drops for eye examination
What does the study involve?
Participants were split into two groups. In both groups, one drop was administered in the traditional method into the right eye; in the left eye, the drop was instilled while the lids were closed. In the first group, the patient was asked to open his or her eye immediately, in the second group the patient was asked to open his or her eye after 10 seconds. The diameters of both pupils were measured before and after 40 minutes after the instillation of the eye drop. After the instillation, the feeling of irritation was evaluated with a visual analogue scale (VAS).
What are the possible benefits and risks of participating?
Patients might benefit from a more comfortable eye drop instillation experience, while the risk is the need for second eye drop instillation in the case the investigated method fails.
Where is the study run from?
University of Kocaeli (Turkey)
When is the study starting and how long is it expected to run for?
November 2017 to January 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Neriman Elibol, nerimanelibol@gmail.com
Contact information
Scientific
Kocaeli Üniversitesi Sağlık Bilimleri Fakültesi Umuttepe Yerleşkesi
Kocaeli
41000
Türkiye
 ORCID ID |
0000-0003-1204-1259 |
|---|---|
| Phone | +90 5425719696 |
| nelibol@kocaeli.edu.tr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single center interventional non-randomized controlled trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Comparing efficiency of different eye drop instilling methods to traditional method within 10-70 age old patients. |
| Study objectives | There is no difference on efficiency between traditional and new eye drop instilling methods. |
| Ethics approval(s) | Approved 07/02/2018, Ethical Committe of Kocaeli University (Kocaeli Üniversitesi Umuttepe Yerleşkesi İzmit/Kocaeli; +902623037500; etikkurul@kocaeli.edu.tr), ref: KÜ GOKAEK 2018/32 |
| Health condition(s) or problem(s) studied | Eye drop instillation method comparison |
| Intervention | Participants were randomly allocated to one of two groups. Participant patients arrive in a random time sequence (Patients arrive for periodic eye examination and asked to join the study prior to the examination and if volunteered patient consents are taken. Patients are not aware of which group they are participating in). The first patient was registered to group 1 and second to group 2 third to group 1 and so on until registrations are closed. One drop of cyclopentolate was administered in the traditional method with the patient’s head tilted back, the lower eyelid held and drop instilled into the inferior fornix in right eye. In the left eye the drop was instilled to the inner canthus while the lids were closed. In the first group the patient was asked to open his or her eye immediately, in the second group the patient asked to open his or her eye after 10 seconds. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Pupil size was measured under constant illumination with the Plusoptix A09 autorefractometer. The diameters of both pupils were measured before and after 40 minutes after the instillation of the eye drop. All drops were instilled by the same investigator while all pupil measurements were made by an ophthalmic specialist technician unaware of the study. |
| Key secondary outcome measure(s) |
Feeling of irritation was evaluated with visual analogue scale (VAS), patients were asked how much irritation felt according to the scale 40 minutes after eye drop instillation |
| Completion date | 30/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 94 |
| Key inclusion criteria | 1. In need of pupil dilatation for ophthalmic examination. 2. Volunteering to participate in this study |
| Key exclusion criteria | 1. Patient requests to be excluded 2. Patients who use of ocular and systemic medications known to affect pupil size, 3. Patients who have pupil effecting disorders like pseudoexfoliation syndrome and pupillary membranes, 4. Patients with history of ocular surgery and trauma and cyclopentolate allergy |
| Date of first enrolment | 01/02/2018 |
| Date of final enrolment | 01/11/2018 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Atatürk Blv. No:2
Kocaeli
41050
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | 26/07/2021 | 03/08/2021 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/08/2021: Trial's existence confirmed by Kocaeli University
