Comparative clinical study of visual results between three types of multifocal lenses
| ISRCTN | ISRCTN46725454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46725454 |
| Secondary identifying numbers | N/A |
- 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
Scientific
University Hospital No. 5 of the Medical University of Silesia
Ceglana 35
Katowice
40-952
Poland
Study information
| Study design | Single-centre, interventional, non-randomised, non-masked study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 05/10/2005 |
| Completion date | 29/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Thirty patients |
| 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
40-952
Poland
Sponsor information
University Hospital No. 5 of the Medical University of Silesia, Katowice (Poland)
Hospital/treatment centre
Hospital/treatment centre
Ul. Ceglana 35
Katowice
40-952
Poland
| Website | http://www.kli-okul.katowice.pl |
|---|---|
"ROR" |
https://ror.org/005k7hp45 |
Funders
Funder type
Hospital/treatment centre
University Hospital No. 5 of the Medical University of Silesia, Katowice (Samodzielny Publicsny Szpital Kliniczny Nr 5 Śląski Uniwersytet Medyczny w Katowicach) (Poland)
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 |
