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

Completed

Conditions: Cataract
Eye Diseases
Other cataract

Registration Number: ISRCTN46725454

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Evaluation of anterior and posterior segments of the eyeball with slit lamp biomicroscope<br>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)<br>3. Examination of uncorrected near visual acuity (UNVA) and best distance corrected near visual acuity (BDCNA) (Jaeger reading chart)<br>4. Axial length<br>5. Intraocular pressure<br>6. Measurement of corneal endothelial cell density<br>7. Contrast sensitivity measurement with CSV-1000 test (Vector Vision)<br>8. Evaluation of pupil size<br>9. Measurement of eye aberration with aberrometer WASCA (Carl Zeiss, Inc.)<br><br>The primary outcomes were measured 1 day, 1 week, 1, 3 and 6 months after surgery.

Secondary Outcome Measures

Name	Time	Method
1. Spectacle dependency<br>2. Subjective satisfaction with vision using the 14-item Visual Function (VF-14) survey<br><br>The secondary outcomes were measured 3 and 6 months after procedure.