Condition category
Eye Diseases
Date applied
18/09/2012
Date assigned
19/10/2012
Last edited
19/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Janos Hargitai

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Thy-Mors Hospital (Denmark)

Sponsor details

Department of Ophthalmology
Højtoftevej 2
Thisted
7700
Denmark

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes

19/10/2017: Plain English summary added.