Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To compare the patients visual results after bilateral implantation of ReZoom™ multifocal intraocular lens (IOL) (NXG1, Advanced Medical Optics), AcrySof® ReSTOR® IOL (SA60D3, Alcon Laboratories) and Tecnis® multifocal IOL (ZM900, Advanced Medical Optics).
Ethics approval
Standard procedure of cataract removal with implantation of intraocular lenses being in common usage means that no ethics board approval was required.
Study design
Single-centre, interventional, non-randomised, non-masked study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cataract
Intervention
Phacoemulsification and aspiration of lens mass were carried out with the Infiniti® Vision System (Alcon Laboratories, Inc.) or Sovereign® Compact (Advanced Medical Optics, Inc.) through 2.8 - 3.0 mm in upper temporal quadrant of transparent cornea with no sutures used and consequent artificial lens implantation to native lens capsule with a single-use injector.
The candidates were provided detailed information concerning the structure and action of each tested multifocal implant and they expressed which type of intraocular lens they would like to have implanted. The doctor also tried to assess the best option for each involved individual based on performing job and lifestyle. Definite reply depended on patient. Follow-up was 6 month in all eyes (from 6 to 13 months).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Evaluation of anterior and posterior segments of the eyeball with slit lamp biomicroscope
2. Examination of uncorrected distance visual acuity (UCDVA) and best distance corrected visual acuity (BDCVA) (logarithm of the minimum angle of resolution [LogMAR] and Snellen's chart)
3. Examination of uncorrected near visual acuity (UNVA) and best distance corrected near visual acuity (BDCNA) (Jaeger reading chart)
4. Axial length
5. Intraocular pressure
6. Measurement of corneal endothelial cell density
7. Contrast sensitivity measurement with CSV-1000 test (Vector Vision)
8. Evaluation of pupil size
9. Measurement of eye aberration with aberrometer WASCA (Carl Zeiss, Inc.)
The primary outcomes were measured 1 day, 1 week, 1, 3 and 6 months after surgery.
Secondary outcome measures
1. Spectacle dependency
2. Subjective satisfaction with vision using the 14-item Visual Function (VF-14) survey
The secondary outcomes were measured 3 and 6 months after procedure.
Overall trial start date
05/10/2005
Overall trial end date
29/05/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 40 - 75 years, either sex
2. Visual acuity equal to or less than 0.7 according to Snellens chart
3. Cataract in both eyes classified according to the Lens Opacities Classification System III (LOCS III)
4. Astigmatism less than 1.5 D
5. Mesopic pupil larger than 3.0 mm
6. Lack of other ophthalmological illnesses, such as:
6.1. Post-transplant cornea
6.2. Irregular astigmatism
6.3. Chronic uveoscleritis
6.4. Damage to ciliary/zonular system of lens
6.5. Pseudoexfoliation syndrome
6.6. Glaucoma
6.7. Previous refractive and anti-glaucomatous operations
6.8. Diabetic retinopathy
6.9. Macular degeneration
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Thirty patients
Participant exclusion criteria
1. Age below 45 and more than 75 years
2. Any other diseases besides cataract
3. Unrealistic expectations concerning vision
4. Patients practising professions which required night-time driving
Recruitment start date
05/10/2005
Recruitment end date
29/05/2007
Locations
Countries of recruitment
Poland
Trial participating centre
University Hospital No. 5 of the Medical University of Silesia
Katowice
40-952
Poland
Sponsor information
Organisation
University Hospital No. 5 of the Medical University of Silesia, Katowice (Poland)
Sponsor details
Ul. Ceglana 35
Katowice
40-952
Poland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital No. 5 of the Medical University of Silesia, Katowice (Samodzielny Publicsny Szpital Kliniczny Nr 5 Śląski Uniwersytet Medyczny w Katowicach) (Poland)
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