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Comparison of monocular implantation of the Acrysof Toric T2 intraocular lens with a standard monofocal intraocular lens in subjects with cataracts and low corneal astigmatism

Phase 4
Withdrawn
Conditions
cataract
10002693
Registration Number
NL-OMON35670
Lead Sponsor
Isala Klinieken
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
10
Inclusion Criteria

Bilateral age-related cataracts necessitating surger
Preoperatieve regular corneal astigmatism of > 0,5 D and <1,0 D
Maximum difference in Best Corrected Visual Acuity (BCVA) between both eyes 0,35 Snellen visus

Exclusion Criteria

Known ocular pathology which can affect the visus: corneal diseases, glaucoma, macula degeneration, (proliferative diabetic) retinopathy and neuro-opthalmic diseases. Previous corneal or intraocular surgery. History of macular edema, uveitis/iritis, retinal detachment or intraocular inflammation. Irregular astigmatism, pupil abnormalities, tear film abnormalities, iris abnormalities, extremely shallow anterior chamber, optic atrophy, microphthalmos, blind or absent follow eye, amblyopia. Pregnancy and lactation.;Pregnancy, lactation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Uncorrected distance visual acuity (UCDVA); pre- en postoperative for each eye</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Best corrected visual acuity (BCDVA): pre- and postoperative for each eye<br /><br>Patient satisfaction with visual acuity for each eye questionnaire pre- and<br /><br>postoperative<br /><br>Manifest refraction (spherical and cylindrical) pre- and postoperative for each<br /><br>eye<br /><br><br /><br><br /><br>Axis of cylinder</p><br>
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