Assessing different pre-operative protocols for cataract surgery in patients taking tamsulosin

ISRCTN ISRCTN37834752
DOI https://doi.org/10.1186/ISRCTN37834752
Secondary identifying numbers N/A
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Janos Hargitai
Scientific

Thy-Mors Hospital
Department of Ophthalmology
Højtoftevej 2
Thisted
7700
Denmark

Study information

Study designProspective randomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEfficacy of mydriatic cocktail-soaked sponge pupil dilation in patients using tamsulosin
Study objectivesA 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) studiedCataract
InterventionPhacoemulsification 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 typeMixed
Primary outcome measurePupillary diameter
Secondary outcome measures1. Adverse effects related to the wick use
2. Intraoperative complications
3. Use of iris hooks
4. Duration of operation
5. Preoperative iris thickness
Overall study start date01/10/2012
Completion date01/02/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50
Key inclusion criteria1. Tamsulosin medication
2. Cataract
Key exclusion criteria1. Previous ocular surgery
2. Posterior synechiae
3. The use of drops other than artificial tears
Date of first enrolment01/10/2012
Date of final enrolment01/02/2013

Locations

Countries of recruitment

  • Denmark

Study participating centre

Thy-Mors Hospital
Thisted
7700
Denmark

Sponsor information

Thy-Mors Hospital (Denmark)
Hospital/treatment centre

Department of Ophthalmology
Højtoftevej 2
Thisted
7700
Denmark

Funders

Funder type

Hospital/treatment centre

Thy-Mors Hospital (Denmark)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

Editorial Notes

19/10/2017: Plain English summary added.