NCT03512626

Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM

Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM (Evolución clínica de Lente Intraocular Multifocal: OPTIVIS.TM)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated visual outcome after cataract surgery with bilateral implantation of either a diffractive - refractive (hybrid) multifocal intraocular lens (MFIOL) or monofocal intraocular lens (IOL) as a control grup.

Detailed description

PURPOSE: To present the outcomes of hybrid multifocal and monofocal intraocular lenses (IOL) SETTING: Parc de Salut Mar, Universidad Pompeu-Fabra - Autónoma, Barcelona, Spain. DESIGN: Prospective clinical trial. METHODS: Consecutive patients with bilateral cataract were included. Phacoemulsification with randomized implantation of either a monofocal IOL (AR40e, AMO-Abbot 30 Laboratories Inc. Abbot Park, Illinois, USA) or multifocal IOL (OptiVis™, Aaren Scientific, Inc, Ontario, CA, USA) was performed by the same surgeon and under the same conditions. Over a 3-month follow-up, the main outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity at 60 cm (UIVA), distance-corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity at 33 cm (UNVA), distance-corrected near visual acuity (DCNVA), spherical equivalent (SE), contrast sensitivity (CS), presence of dysphotopsia, use of spectacles and patient satisfaction with the test VF-14 (Visual Function Index) .

Conditions

• Cataract Senile
• Lenses, Intraocular

Interventions

Type	Name	Description
DEVICE	OptiVis, Aaren Scientific	All the surgeries were performed under topical anesthesia using a standard phacoemulsification procedure with Infiniti Vision System (all from Alcon Laboratories, Inc, Fort Worth, TX).
DEVICE	Monofocal IOL	All the surgeries were performed under topical anesthesia using a standard phacoemulsification procedure with Infiniti Vision System (all from Alcon Laboratories, Inc, Fort Worth, TX).

Timeline

• Start date: 2014-06-04
• Primary completion: 2015-06-04
• Completion: 2015-06-04
• First posted: 2018-05-01
• Last updated: 2018-05-01

Regulatory

• FDA-regulated device study