Comparative clinical study of visual results between three types of multifocal lenses

ISRCTN	ISRCTN46725454
DOI	https://doi.org/10.1186/ISRCTN46725454
Protocol serial number	N/A
Sponsor	University Hospital No. 5 of the Medical University of Silesia, Katowice (Poland)
Funder	University Hospital No. 5 of the Medical University of Silesia, Katowice (Samodzielny Publicsny Szpital Kliniczny Nr 5 Śląski Uniwersytet Medyczny w Katowicach) (Poland)

Submission date: 17/04/2008
Registration date: 25/11/2008
Last edited: 25/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stanislawa Gierek-Ciaciura
Scientific

University Hospital No. 5 of the Medical University of Silesia
Ceglana 35
Katowice
40-952
Poland

Study information

Primary study design	Interventional
Study design	Single-centre, interventional, non-randomised, non-masked study
Secondary study design	Non randomised controlled trial
Scientific title
Study objectives	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(s)	Standard procedure of cataract removal with implantation of intraocular lenses being in common usage means that no ethics board approval was required.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	29/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	05/10/2005
Date of final enrolment	29/05/2007

Locations

Countries of recruitment

Poland

Study participating centre

University Hospital No. 5 of the Medical University of Silesia

Katowice
40-952
Poland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan