Assessing different pre-operative protocols for cataract surgery in patients taking tamsulosin
| ISRCTN | ISRCTN37834752 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37834752 |
| Protocol serial number | N/A |
| Sponsor | Thy-Mors Hospital (Denmark) |
| Funder | Thy-Mors Hospital (Denmark) |
- Submission date
- 18/09/2012
- Registration date
- 19/10/2012
- Last edited
- 19/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Intraoperative floppy iris syndrome (IFIS) is a complication that can occur during cataract extraction. It has linked with the use of the medication tamsulosin. IFIS may cause the pupil to constrict and increase the risk of vision-threatening complications of cataract surgery, particularly when surgeons are unaware of the patient’s medical history. Previous studies found that the use of a wick pre-soaked in standard pupil-dilating (mydriatic) and non-steroidal anti-inflammatory drugs was as effective as or better than the conventional repeated use of drops before cataract surgery. The aim of this study is to assess the effectiveness of a mydriatic cocktail-soaked sponge as an alternative method of pupil dilation in high-risk patients taking tamsulosin.
Who can participate?
Male patients (either taking tamsulosin or not) undergoing cataract surgery
What does the study involve?
Patients taking tamsulosin are randomly allocated into two groups. One group have their pupils dilated using a mydriatic cocktail-soaked sponge. The other group have their pupils dilated with conventional repeated eye drops. Patients not taking tamsulosin have their pupils dilated using the mydriatic cocktail-soaked sponge. Any side effects associated with the use of the sponge are recorded. All patients undergo standard cataract surgery. Pupil size, surgical complications, use of iris hooks, operation time and iris thickness are measured.
What are the possible benefits and risks of participating?
Participants benefit from an extended assessment before their operation, which may further reduce surgical complications. The risks are not higher than standard cataract surgery.
Where is the study run from?
Thy-Mors Hospital (Denmark)
When is the study starting and how long is it expected to run for?
October 2012 to February 2013
Who is funding the study?
Thy-Mors Hospital (Denmark)
Who is the main contact?
Dr Janos Hargitai
Contact information
Scientific
Thy-Mors Hospital
Department of Ophthalmology
Højtoftevej 2
Thisted
7700
Denmark
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy of mydriatic cocktail-soaked sponge pupil dilation in patients using tamsulosin |
| Study objectives | A mydriatic-cocktail soaked cellulose sponge showed satisfactory effect in dilating pupils preoperatively, however this method was not tested in high risk patients such as patients taking tamsulosin. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cataract |
| Intervention | Phacoemulsification cataract surgery The tamsulosin group will be randomized into two groups: Group 1 will be dilated using a mydriatic cocktail-soaked sponge Group 2 will be dilated with conventional repeated eyedrop regimen The control group (Group 3) will be dilated using the mydriatic cocktail- soaked sponge |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Pupillary diameter |
| Key secondary outcome measure(s) |
1. Adverse effects related to the wick use |
| Completion date | 01/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Tamsulosin medication 2. Cataract |
| Key exclusion criteria | 1. Previous ocular surgery 2. Posterior synechiae 3. The use of drops other than artificial tears |
| Date of first enrolment | 01/10/2012 |
| Date of final enrolment | 01/02/2013 |
Locations
Countries of recruitment
- Denmark
Study participating centre
7700
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/12/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/10/2017: Plain English summary added.
