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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46725454
Enrollment
30
Registered
2008-11-25
Start date
2005-10-05
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Eye Diseases Other cataract

Interventions

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

Sponsors

University Hospital No. 5 of the Medical University of Silesia, Katowice (Poland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 40 - 75 years, either sex 2. Visual acuity equal to or less than 0.7 according to Snellen?s 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026