WithdrawnNot Applicable

Study of the Effect of Aspheric Lenses in Patients With Fuch's Dystrophy

Stopped: not enough participants

Canada0Started 2014-04

Plain-language summary

The proposed study will recruit patients with mild to moderate Fuch's dystrophy who need cataract surgery alone. They will be randomly assigned to receive either spheric or aspheric lenses. If both eyes of a patient need surgery, we will implant the same type of lens in each eye in order to prevent imbalanced vision. We will measure their contrast sensitivity and higher order aberrations before surgery and 3 months after surgery. We will compare the change in these values between the two groups.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age 18 and 80 years * Visual acuity better than 0.2 logMAR units * preoperative corneal spherical aberration (Zo4) values between 0.1 and 0.25 µm at 5-mm pupil diameter * IOL power between +18.00 and +24.00 diopters Exclusion Criteria: * Intraocular lens tilt and decentration estimated by retroillumination * surgical complications * posterior capsule rupture * residual posterior capsule plaque * posterior capsular opacity * post operative Best Corrected Visual Acuity \<20/25 * corneal astigmatism \>= 1.00 D * glaucoma * amblyopia, * history of uveitis * diabetic retinopathy, * pseudoexfoliation syndrome * macular pathology previous intraocular surgery * coexisting ocular pathology * axial length \>25mm * non dilating pupils * corneal laser therapy * poor follow up * use of topical medications (apart from lubricants) * systemic steroids use

What they're measuring

Change in contrast sensitivity.

Timeframe: 3 months (plus or minus 1 week) post operatively

Trial details

NCT IDNCT02109276

SponsorQueen's University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06