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

Background 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.

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.



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.

Preop, 1 week first eye, 1 week second eye, 1 month both eyes, 3 months both eyes, 6 months both eyes.

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).