Clinical evaluation of two phacoemulsification tips: 23G phacoemulsification tip in comparison to 20G CMP phacoemulsification tip
| ISRCTN | ISRCTN72610588 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72610588 |
| Secondary identifying numbers | 690/2007 |
- Submission date
- 12/06/2012
- Registration date
- 10/08/2012
- Last edited
- 12/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
Department of Ophthalmology
Medical University of Vienna
Waehringer Guertel 18-20
Vienna
1090
Austria
| rupert.menapace@meduniwien.ac.at |
Study information
| Study design | Prospective randomised single-masked clinical trial with within-patient comparison |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Clinical evaluation of two phacoemulsification tips: 23G phacoemulsification tip in comparison to 20G CMP phacoemulsification tip - a randomised trial |
| Study objectives | 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(s) | The Ethics Committee of the Medical University of Vienna (Borschkegasse 8b/E 06, A-1090 Vienna, Austria), 13/03/2007, EK-Nr.: 690/2007 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2008 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 patients (100 eyes) |
| Key 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 |
| Key exclusion criteria | 1. Anamnesis or clinical signs of uveitis 2. Glaucoma 3. Proliferative diabetic retinopathy 4. Trauma 5. Small pupil 6. Previous ophthalmic operation |
| Date of first enrolment | 01/04/2008 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- Austria
Study participating centre
1090
Austria
Sponsor information
Hospital/treatment centre
Medical University of Vienna
Waehringer Guertel 18-20
Vienna
1090
Austria
"ROR" |
https://ror.org/05n3x4p02 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
