Clinical trial NCT03512626: Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM
Official title: Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM (Evolución clínica de Lente Intraocular Multifocal: OPTIVIS.TM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Senile
Lenses, Intraocular
Keywords: OptiVis
hybrid multifocal intraocular lens
multifocal intraocular lens
presbyopia
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consecutive patients with bilateral cataract were included after meeting all the inclusion and none of exclusion criteria and when written informed consent was obtained from all patients.

Patients were randomly assigned to have bilateral implantation with either a monofocal IOL (AR40e, AMO-Abbot 30 Laboratories Inc. Abbot Park, Illinois, USA) or multifocal IOL (OptiVis™, Aaren Scientific, Inc, Ontario, CA, USA).
Primary purpose: TREATMENT

Brief 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) .

Eligibility criteria: Inclusion Criteria:

* senile cataract with Snellen visual acuity ≤ 0.5,
* motivation for spectacle independence for near vision (as the study was conducted in Spanish public health care system, entering study was the only option to get multifocal lens, as they are not provided by public health care, and the patients were conscious of the possibility of randomization to monofocal group.)

Exclusion Criteria:

* corneal astigmatism ≥ 1.10 diopters (D) and irregular astigmatism,
* axial length \< 21.5 or ≥ 25 mm,
* pupillary diameter in mesopic conditions in distance vision ≤ 2.5 mm and ≥ 6 mm,
* ocular pathology that could affect the visual function and/or intraocular lens centering and intraoperative or postoperative complications.
* highly demanding patients and those whose profession could be affected by a multifocal design (professional drivers, jewelers etc.) were also excluded (as in the Spanish public health care system secondary procedures needed to satisfy patients' expectation, such as LRI´s, LASIK, PRK´s, are not available).

Primary outcomes:
measure: Visual function
timeFrame: The last follow-up visit (3 months after the surgery)
Secondary outcomes:
measure: Contrast sensitivity (CS)
timeFrame: The last follow-up visit (3 months after the surgery)
measure: Refractive Outcomes
timeFrame: The last follow-up visit (3 months after the surgery)
measure: Spectacle dependence
timeFrame: The last follow-up visit (3 months after the surgery)
measure: Presence of dysphotopsia
timeFrame: The last follow-up visit (3 months after the surgery)
measure: Patient satisfaction
timeFrame: The last follow-up visit (3 months after the surgery)
Other outcomes:
Locations:
Study officials:
affiliation: Parc de Salut Mar, Barcelona, Spain
name: Ana Martinez Palmer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12(12):CD003169. doi: 10.1002/14651858.CD003169.pub4.
citation: Cochener B, Lafuma A, Khoshnood B, Courouve L, Berdeaux G. Comparison of outcomes with multifocal intraocular lenses: a meta-analysis. Clin Ophthalmol. 2011 Jan 7;5:45-56. doi: 10.2147/OPTH.S14325.
citation: Piovella M, Bosc JM. Clinical evaluation of the OptiVis multifocal intraocular lens. Adv Ther. 2011 Nov;28(11):1012-20. doi: 10.1007/s12325-011-0064-7. Epub 2011 Oct 31.
citation: Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD003169. doi: 10.1002/14651858.CD003169.pub3.
citation: de Vries NE, Nuijts RM. Multifocal intraocular lenses in cataract surgery: literature review of benefits and side effects. J Cataract Refract Surg. 2013 Feb;39(2):268-78. doi: 10.1016/j.jcrs.2012.12.002.
citation: Dyrda A, Martinez-Palmer A, Martin-Moral D, Rey A, Morilla A, Castilla-Marti M, Arones-Santivanez J. Clinical Results of Diffractive, Refractive, Hybrid Multifocal, and Monofocal Intraocular Lenses. J Ophthalmol. 2018 Jun 25;2018:8285637. doi: 10.1155/2018/8285637. eCollection 2018.