Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM

Not Applicable

Completed

• Conditions: Cataract Senile; Lenses, Intraocular
• Interventions: Device: OptiVis, Aaren Scientific; Device: Monofocal IOL

• Registration Number: NCT03512626
• Lead Sponsor: Parc de Salut Mar

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) .

Study Timeline

• Study Start: 2014-06-04
• Primary Completion: 2015-06-04
• Study Completion: 2015-06-04
• Status Verified: 2018-04
• Study First Submitted: 2018-04-08
• Study First Submitted QC: 2018-04-18
• Last Update Submitted: 2018-04-18
• Study First Posted: 2018-05-01
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multifocal IOL (OptiVis)	OptiVis, Aaren Scientific	Ambulatory surgery was performed by the same, experienced surgeon, under topical anesthesia, using as a technique phacoemulsification with small incision (2.75) in clear cornea in the most curved meridian. The randomly assigned IOL (in this arm: a hybrid (refractive-diffractive) multifocal IOL (OptiVis, Aaren Scientific) was implanted in the capsular bag. The second eye with the same type of lens of the first eye was operated within 2-4 weeks.
Monofocal IOL	Monofocal IOL	Ambulatory surgery was performed by the same, experienced surgeon, under topical anesthesia, using as a technique phacoemulsification with small incision (2.75) in clear cornea in the most curved meridian. The randomly assigned IOL (in this arm: a monofocal IOL (AR40e, AMO) was implanted in the capsular bag. The second eye with the same type of lens of the first eye was operated within 2-4 weeks.

Primary Outcome Measures

Name	Time	Method
Visual function	The last follow-up visit (3 months after the surgery)	Changes in visual acuity in logMAR: uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) at 6 m, uncorrected intermediate visual acuity (UIVA), distance-corrected intermediate visual acuity (DCIVA) at 60 cm (in the OptiVis group only, as they were supposed to provide intermediate distance vision in contrary to monofocal lenses), uncorrected near visual acuity (UNVA) and distance-corrected near visual acuity (DCNVA) at 33 cm. All measured using Snellen acuity charts under photopic conditions.

Secondary Outcome Measures

Name	Time	Method
Contrast sensitivity (CS)	The last follow-up visit (3 months after the surgery)	Changes in monocular and binocular CS were measured in mesopic conditions, without glare at spatial frequencies of 1.5, 3, 6, 12 and 18 cycles per degree (cpd) using the Functional Acuity Contrast Test (FACT, OPTEC 6500®, Stereo Optical Co. Inc)
Refractive Outcomes	The last follow-up visit (3 months after the surgery)	The predictability of the refractive outcome. Postoperative spherical equivalent (SE) and SE within ±0.50 D of the attempted spherical correction (emmetropy) and within ±1.00 D of the attempted spherical correction (emmetropy).
Spectacle dependence	The last follow-up visit (3 months after the surgery)	Spectacle dependence, determined by questionnaire (Do you wear glasses for distance/near vision?).
Presence of dysphotopsia	The last follow-up visit (3 months after the surgery)	Presence of dysphotopsia (halos, glare), spontaneously mentioned or elicited in response to questioning were determined by questionnaire.
Patient satisfaction	The last follow-up visit (3 months after the surgery)	Patient satisfaction was also assessed with the VF-14 test, consisting of 14 questions evaluating various patient activities.