Correction of presbyopia after cataract surgery by multifocal intraocular lenses (IOLs) Correctie van presbyopie (ouderdomsverziendheid) na een cataractoperatie (staaroperatie) met intraoculaire implantlenzen (IOLs)
Conditions
Interventions
Cataract extraction in both eyes with implantation of a multifocal intraocular lens (the multifocal FineVision Micro F IOL or the multifocal AcrySof® IQ ReSTOR® +3 IOL).
Sponsors
University Eye Clinic Maastricht, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Bilateral cataract; 2. Less than 1.00 diopters of corneal astigmatism in both eyes; 3. Fulfill the recommendations in the “Warnings” and “Precautions” sections of the AcrySof ReSTOR and FineVision package inserts*; 4. Age 42 years or older; 5. Expected postoperative best-corrected visual acuity of logMAR +0.3 or better; 6. Availability to undergo second eye surgery within 2 weeks of the first eye surgery; 7. Willing and able to comply with scheduled visits and other study procedures; 8. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Planned multiple procedures, including LRI, during cataract/IOL implantation surgery; 2. Previous corneal surgery and/or reshaping; 3. Clinically significant corneal endothelial dystrophy (e.g., Fuchs’ dystrophy); 4. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.); 5. Extensive age related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen); 6. Glaucoma related extensive visual field loss; 7. Extensive diabetic macular disease; 8. Suturing of incision required at time of surgery; 9. 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: 1. Mean unilateral UCVA at near (40cm), intermediate (70cm) and distance (4m) at photopic and mesopic conditions at 1, 3 and 6 months postoperatively; 2. Mean bilateral UCVA at near (40cm), intermediate (70cm) and distance (4m) at photopic and mesopic conditions at 1, 3 and 6 months postoperatively; 3. Mean unilateral DCVA at near (40cm), intermediate (70cm) and distance (4m) at photopic and mesopic conditions at 1, 3 and 6 months postoperatively; 4. 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; 5. Mean contrast sensitivity monocular and binocular at photopic and mesopic conditions at 1, 3 and 6 months postoperatively; 6. Reading speed at photopic and mesopic conditions at 6 months postoperatively; 7. Mean vision-specific quality of life at 6 months postoperatively. Furthermore, adverse events, including complications, will be reported for each patient. | — |
Contacts
Public ContactFrank Biggelaar, van den
PO Box 5800
Outcome results
None listed