Condition category
Eye Diseases
Date applied
12/06/2012
Date assigned
10/08/2012
Last edited
12/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cataracts are cloudy patches that develop in the lens of the eye and can cause blurred or misty vision. Phacoemulsification cataract surgery is a procedure in which an ultrasonic device is used to break up and then remove a cloudy lens from the eye to improve vision. An artificial intraocular lens is then inserted into the eye. Modern micro-incision cataract surgery aims to reduce the size of the incision needed for the surgery by using smaller intraocular lenses and phacoemulsification tips. This may result in less operative trauma. The aim of this study is to compare a 23 gauge (G) phacoemulsification tip to a conventional 20G phacoemulsification tip for micro-incision cataract surgery.

Who can participate?
Patients aged 55-88 with age-related bilateral cataracts (i.e., in both eyes) and scheduled to undergo bilateral cataract surgery at our hospital.

What does the study involve?
A conventional 23G phacoemulsification tip will be used for the cataract surgery in one eye, while in the other eye cataract surgery will be performed with a 20G phacoemulsification tip. The follow-up care will be at our hospital. Visits will be 1 week and 6 months after surgery. The visits will include standard postoperative care and a measurement of the cornea of the eye.

What are the possible benefits and risks of participating?
Cataract operations are generally very successful, with a low risk of serious complications. We do not expect any additional risk due to participation in the study. There may be no direct benefits for the participants, but the smaller incisions used for the 23G tip may lead to a faster recovery.

Where is the study run from?
Medical University of Vienna (Austria).

When is the study starting and how long is it expected to run for?
The study ran from April 2008 to April 2011.

Who is funding the study?
Medical University of Vienna (Austria).

Who is the main contact?
Dr Rupert Menapace
rupert.menapace@meduniwien.ac.at

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rupert Menapace

ORCID ID

Contact details

Department of Ophthalmology
Medical University of Vienna
Waehringer Guertel 18-20
Vienna
1090
Austria
rupert.menapace@meduniwien.ac.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

690/2007

Study information

Scientific title

Clinical evaluation of two phacoemulsification tips: 23G phacoemulsification tip in comparison to 20G CMP phacoemulsification tip - a randomised trial

Acronym

Study hypothesis

To compare the intraoperative efficiency, safety and postoperative outcomes after cataract surgery with two different phacoemulsification tips - 23G phacoemulsification tip for co-axial higher-fluidics phacoemulsification compared to CMP 20G phacoemulsification tip for co-axial lower-fluidics phacoemulsification.

Ethics approval

The Ethics Committee of the Medical University of Vienna (Borschkegasse 8b/E 06, A-1090 Vienna, Austria), 13/03/2007, EK-Nr.: 690/2007

Study design

Prospective randomised single-masked clinical trial with within-patient comparison

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 below to request a patient information sheet

Condition

Cataract surgery

Intervention

Cataract surgery will be performed under topical anaesthesia through a 3.0 mm temporal self-sealing sclero-corneal tunnel incision. In all techniques, the Anterior Continuous Curvilinear Capsulorhexis (ACCC) with appropriate overlap of the intraocular lens (IOL) optic will be created using a needle. Thereafter hydrodissection, phacoemulsification and irrigation/aspiration of the lens will be performed.

In randomised order, cataract surgery with a 23G phacoemulsification tip will be performed in one eye; in the fellow eye cataract surgery will be performed with the 20G phacoemulsification tip.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Phacoemulsification time (sec)
2. Maximum phacoemulsification power (%)

Secondary outcome measures

1. Overall surgery time (min)
2. Length of corneal incision (mm)
3. Stability of anterior chamber
4. Corneal stress (semiquantitatively)
5. Anterior chamber flare measurement (LFCM)
6. Corneal endothelial cell count
7. Pachymetry
8. Corneal topography and keratometry

Overall trial start date

01/04/2008

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with age-related cataracts in both eyes awaiting bilateral same-day cataract surgery
2. Age range: 55 - 88 years, both male and female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 patients (100 eyes)

Participant exclusion criteria

1. Anamnesis or clinical signs of uveitis
2. Glaucoma
3. Proliferative diabetic retinopathy
4. Trauma
5. Small pupil
6. Previous ophthalmic operation

Recruitment start date

01/04/2008

Recruitment end date

01/04/2011

Locations

Countries of recruitment

Austria

Trial participating centre

Department of Ophthalmology
Vienna
1090
Austria

Sponsor information

Organisation

Medical University of Vienna (Austria)

Sponsor details

Medical University of Vienna
Waehringer Guertel 18-20
Vienna
1090
Austria

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Medical University of Vienna (Austria)

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

Publication citations

Additional files

Editorial Notes