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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list