Cataract Clinical Trial
Official title:
Comparison Between Bilateral Low-add Multifocal Intraocular Lenses and Monofocal Intraocular Lenses: A Randomised Trial
Compare low-add multifocal IOLs with monofocal IOLs to evaluate if patients in the low-add multifocal IOL group have better unaided distance visual acuity compared to the monofocal group.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 1, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 105 Years |
Eligibility |
Inclusion Criteria: - Age-related cataract in both eyes - Scheduled for bilateral cataract surgery - Motivated to be less spectacle dependant in the distance to intermediate vision range - Patients with an expected BCDVA of 0.8 snellen score or better after surgery - Patients with the need of an IOL Power in the range of 10 to 30D (biometry performed with the IOL master 700) - Age 21 and older - Written informed consent prior to recruitment Exclusion Criteria: - Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age) - Retinopathia pigmentosa - Chronic uveitis - Amblyopia - Pupil decentration > 1mm center shift - preceded retinal surgery - preceded Laser-in-situ-Keratomileusis (LASIK) - Any ophthalmic abnormality that could compromise visual function or the measurements |
Country | Name | City | State |
---|---|---|---|
Austria | Vienna Institute for Research in Ocular Surgery (VIROS) | Vienna |
Lead Sponsor | Collaborator |
---|---|
Prim. Prof. Dr. Oliver Findl, MBA |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spectacle independence questionnaire | Spectacle independence will be assessed using a questionnaire. In this questionnaire the patient will be asked about usage of spectacles for far, near and intermediate distance. Best result will be if the patient is independent from any spectacles in the different distances. | 12 months | |
Secondary | Best Corrected Distance Visual Acuity and Uncorrected Intermediate Visual Acuity | Best corrected distance and uncorrected intermediate visual acuity will be assessed using the ETDRS charts | 12 months | |
Secondary | Titmus Fly Stereo test | Stereo Vision assessment will be done using the Titmus Fly Stereo test. The patients will be asked to detect stereoscopic objects of different difficulty levels. The result will be better, the more correct stereoscopic objects the patient will detect. | 12 months |
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