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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Fuch's Endothelial Dystrophy trials