Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM

Cataract Senile Clinical Trial

— MFIOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512626
• Other study ID #: 2013/5432/I
• Status: Completed
• Phase: N/A
• Start date: June 4, 2014
• Est. completion date: June 4, 2015

Study information

• Verified date: April 2018
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 4, 2015
• Est. primary completion date: June 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cataract
• Cataract Senile
• Lenses, Intraocular

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

References & Publications (5)

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. Review. Update in: Cochrane Database Syst Rev. 2016 Dec 12;12 :CD003169. — View 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. — View 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:CD003169. doi: 10.1002/14651858.CD003169.pub4. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Results of this study included. Outcomes of hybrid multifocal and monofocal intraocular lenses (IOLs) and comparison with refractive and diffractive multifocal IOLs. 320eyes(160 patients) underwent cataract surgery with randomized bilateral implantation