Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy of mydriatic cocktail-soaked sponge pupil dilation in patients using tamsulosin
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Prospective randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
Pupillary diameter
Secondary outcome measures
1. Adverse effects related to the wick use
2. Intraoperative complications
3. Use of iris hooks
4. Duration of operation
5. Preoperative iris thickness
Overall trial start date
01/10/2012
Overall trial end date
01/02/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Tamsulosin medication
2. Cataract
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Previous ocular surgery
2. Posterior synechiae
3. The use of drops other than artificial tears
Recruitment start date
01/10/2012
Recruitment end date
01/02/2013
Locations
Countries of recruitment
Denmark
Trial participating centre
Thy-Mors Hospital
Thisted
7700
Denmark
Funders
Funder type
Hospital/treatment centre
Funder name
Thy-Mors Hospital (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24359572
Publication citations
-
Results
Hargitai J, Vezendi L, Vigstrup J, Eisgart F, Lundbye-Christensen S, Hargitai B, Vorum H, Comparing the efficacy of mydriatic cocktail-soaked sponge and conventional pupil dilation in patients using tamsulosin - a randomized controlled trial., BMC Ophthalmol, 2013, 13, 83, doi: 10.1186/1471-2415-13-83.