bilateral cataract presbyopia
Conditions
Interventions
The intervention will be bilateral cataract surgery with implantation of a
multifocal IOL.
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *Bilateral cataract *Less than 1.00 diopters of corneal astigmatism in both eyes *Fulfill the recommendations in the *Warnings* and *Precautions* sections of the AcrySof ReSTOR and FineVision package inserts* *Age 42 years or older *Expected postoperative logMAR +0.3 or better *Availability to undergo second eye surgery within 2 weeks of the first eye surgery *Willing and able to comply with scheduled visits and other study procedures *Signed informed consent
Exclusion criteria
Exclusion criteria: *Planned multiple procedures, including LRI, during cataract/IOL implantation surgery *Previous corneal surgery and/or reshaping *Clinically significant corneal endothelial dystrophy (e.g., Fuchs* dystrophy) *History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) *Extensive age related macular degeneration (atrophic or exudative AMD or numerous soft drusen) *Glaucoma related extensive visual field loss *Extensive Diabetic macular disease *Suturing of incision required at time of surgery *Complications during surgery of the first eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure is the mean bilateral DCVA at intermediate distance (70cm) under mesopic conditions at 1, 3 and 6 months postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are: *Mean unilateral UCVA at near (40cm), intermediate (70cm) and distance (4m) at photopic and mesopic conditions at 1, 3 and 6 months postoperatively *Mean bilateral UCVA at near (40cm), intermediate (70cm) and distance (4m) at photopic and mesopic conditions at 1, 3 and 6 months postoperatively *Mean unilateral DCVA at near (40cm), intermediate (70cm) and distance (4m) at photopic and mesopic conditions at 1, 3 and 6 months postoperatively *Mean bilateral DCVA at near (40cm), intermediate (70cm) and distance (4m) at photopic conditions and mean bilateral DCVA at near (40cm) and distance (4m) at mesopic conditions at 1, 3 and 6 months postoperatively *Mean contrast sensitivity monocular and binocular at photopic and mesopic conditions at 1, 3 and 6 months postoperatively *Reading speed at photopic and mesopic conditions at 6 months postoperatively *Mean vision-specific quality of life at 6 months postoperatively. Furthermore, adverse events, including complications, will be reported for each patient. | — |
Countries
Netherlands
Outcome results
None listed