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A randomized, subject-blinded evaluation of visual function after bilateral implantation of two types of presbyopia-correcting multifocal IOLs.


- candidate number13194
- NTR NumberNTR3556
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2012
- Secondary IDs12-T-23 
- Public TitleA randomized, subject-blinded evaluation of visual function after bilateral implantation of two types of presbyopia-correcting multifocal IOLs.
- Scientific TitleA randomized, subject-blinded evaluation of visual function after bilateral implantation of two types of presbyopia-correcting multifocal IOLs.
- ACRONYM
- hypothesisPresbyopia is a progressive decline in the ability to focus on near objects with increasing age. Conventional management of presbyopia has been through bifocal and multifocal progressive spectacle lenses or contact lenses. Recent advances in technology have allowed surgical correction of presbyopia through intraocular lenses (IOLs) among patients undergoing cataract extraction or refractive lens exchange. Presbyopia correcting IOLs are becoming increasingly popular as they may help achieve freedom from spectacles. Two types of presbyopia correcting IOLs are the multifocal FineVision Micro F IOL and the multifocal AcrySof® IQ ReSTOR® +3 IOL.
Although the FineVision Micro F IOL has the potential to have better intermediate vision without loss of far and near vision compared to the AcrySof® IQ ReSTOR® +3 IOL, this has never been evaluated in a well-controlled, randomized, prospective study.

The objective of this study is to prospectively evaluate postoperative visual outcomes in a randomized clinical trial of patients bilaterally implanted with the FineVision Micro F IOL versus those bilaterally implanted with the AcrySof® IQ ReSTOR® Aspheric +3 D multifocal IOL.
- Healt Condition(s) or Problem(s) studiedPresbyopia, Cataract surgery, Multifocal intraocular lenses (IOLs)
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-aug-2012
- planned closingdate1-jul-2013
- Target number of participants28
- InterventionsCataract 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).
- Primary outcomePrimary outcome measure is the mean bilateral DCVA at intermediate distance (70cm) under mesopic conditions at 1, 3 and 6 months postoperatively.
- Secondary outcomeSecondary 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.
- TimepointsPreop, 1 week first eye, 1 week second eye, 1 month both eyes, 3 months both eyes, 6 months both eyes.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Frank Biggelaar, van den
- CONTACT for SCIENTIFIC QUERIESMD., PhD. Rudy M.M.A. Nuijts
- Sponsor/Initiator University Eye Clinic Maastricht
- Funding
(Source(s) of Monetary or Material Support)
PhysIOL, Liège, Belgium
- PublicationsN/A
- Brief summaryBackground of the study:
Presbyopia is a progressive decline in the ability to focus on near objects with increasing age. Conventional management of presbyopia has been through bifocal and multifocal progressive spectacle lenses or contact lenses. Recent advances in technology have allowed surgical correction of presbyopia through intraocular lenses (IOLs) among patients undergoing cataract extraction or refractive lens exchange. Presbyopia correcting IOLs are becoming increasingly popular as they may help achieve freedom from spectacles. Two types of presbyopia correcting IOLs are the multifocal FineVision Micro F IOL and the multifocal AcrySof® IQ ReSTOR® +3 IOL.
Although the FineVision Micro F IOL has the potential to have better intermediate vision without loss of far and near vision compared to the AcrySof® IQ ReSTOR® +3 IOL, this has never been evaluated in a well-controlled, randomized, prospective study.

Objective of the study:
The objective of this study is to prospectively evaluate postoperative visual outcomes in a series of patients bilaterally implanted with the FineVision Micro F IOL versus those bilaterally implanted with the AcrySof® IQ ReSTOR® Aspheric +3 D multifocal IOL.

Study design:
The study design is a randomised clinical study to compare outcomes after implantation with the FineVision versus implantation with the AcrySof ReSTOR. A total of 28 patients will be randomised into either the FineVision group or the AcrySof ReSTOR group at a 1:1 ratio. Patients will receive standard cataract extractions with implantation of an IOL in both eyes. Patients will be examined pre-operatively and 1 week, and 1, 3 and 6 months postoperatively. The duration of the study is 15 months, based on the inclusion of patients into the RCT in the first 6 months, a follow-up of 6 months after IOL implantation and analysis of the data during the last 3 months of the study.

Main study parameters/endpoints:
Primary outcome measure is the mean bilateral DCVA at intermediate distance (70cm) under mesopic conditions at 1, 3 and 6 months postoperatively.
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.
- Main changes (audit trail)
- RECORD2-aug-2012 - 16-aug-2012


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