Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM

Study Overview
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Brief Summary
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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
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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) .

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

Conditions
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Cataract Senile, Lenses, Intraocular

Intervention / Treatment
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* Device: OptiVis, Aaren Scientific
* Device: Monofocal IOL


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifocal IOL (OptiVis)<br>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. | Device: OptiVis, Aaren Scientific<br>* 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).<br>* Other names: a hybrid multifocal intraocular lens;|
| Active Comparator: Monofocal IOL<br>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. | Device: Monofocal IOL<br>* 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).<br>* Other names: AR40e, AMO-Abbot 30 Laboratories Inc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual function | 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. | The last follow-up visit (3 months after the surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast sensitivity (CS) | 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) | The last follow-up visit (3 months after the surgery) | 
| Refractive Outcomes | 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). | The last follow-up visit (3 months after the surgery) | 
| Spectacle dependence | Spectacle dependence, determined by questionnaire (Do you wear glasses for distance/near vision?). | The last follow-up visit (3 months after the surgery) | 
| Presence of dysphotopsia | Presence of dysphotopsia (halos, glare), spontaneously mentioned or elicited in response to questioning were determined by questionnaire. | The last follow-up visit (3 months after the surgery) | 
| Patient satisfaction | Patient satisfaction was also assessed with the VF-14 test, consisting of 14 questions evaluating various patient activities. | The last follow-up visit (3 months after the surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OptiVis, hybrid multifocal intraocular lens, multifocal intraocular lens, presbyopia