Visual Performance of New Apodized Diffractive Multifocal IOL With Addition of Plus Three - Full Text View

Purpose

The purpose of the study is to determine whether implantation of a multifocal IOL with a modified addition at lens plane(Restor +3) results in better intermediate visual acuity with similar performance at distance and near compared to other multifocal IOL with similar design but with higher addition at lens plane. Patient's contrast sensitivity of vision and best reading distance following Restor +3 implantation were also assessed.

Study hypothesis: the implantation of an intraocular lens (IOL) with a modified addition at lens plane (restor +3, Alcon Laboratories,Inc) results in better intermediate visual acuity with similar distance and near visual acuity after cataract surgery.

Condition	Intervention
To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual Acuity	Other: Implantation of a multifocal Intraocular lens

Study Type:	Observational
Study Design:	Time Perspective: Prospective

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

distance,intermediate and near visual acuity [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

reading speed and contrast sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	32
Study Start Date:	December 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Restor +3 patients will be implanted bilaterally with Restor + 3	Other: Implantation of a multifocal Intraocular lens Bilateral implantation of a multifocal IOl Other Names: Restor + 3 SN6AD1 Restor + 4 SN6AD3
restor +4 Patients will be implanted bilaterally with Restor +4	Other: Implantation of a multifocal Intraocular lens Bilateral implantation of a multifocal IOl Other Names: Restor + 3 SN6AD1 Restor + 4 SN6AD3

Detailed Description:

Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.

Patients will be examined before surgery and at 1, 7, 30, 90 days and 3and 6 months after surgery.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

The sutdy population will be patients implanted bilaterally with the selected multifocal IOL

Criteria

Inclusion Criteria:

•Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters)

Exclusion Criteria:

Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities
Surgical complications
Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)
Incomplete follow-up.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027533

Locations

Brazil
University of São Paulo
São Paulo, SP, Brazil, 054000

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator:

Marcony Santhiago, MD

University of São Paulo

More Information

Publications:

Gupta N, Wolffsohn JS, Naroo SA. Comparison of near visual acuity and reading metrics in presbyopia correction. J Cataract Refract Surg. 2009 Aug;35(8):1401-9.

Biber JM, Sandoval HP, Trivedi RH, de Castro LE, French JW, Solomon KD. Comparison of the incidence and visual significance of posterior capsule opacification between multifocal spherical, monofocal spherical, and monofocal aspheric intraocular lenses. J Cataract Refract Surg. 2009 Jul;35(7):1234-8.

Alfonso JF, Fernández-Vega L, Amhaz H, Montés-Micó R, Valcárcel B, Ferrer-Blasco T. Visual function after implantation of an aspheric bifocal intraocular lens. J Cataract Refract Surg. 2009 May;35(5):885-92.

Hayashi K, Yoshida M, Hayashi H. All-distance visual acuity and contrast visual acuity in eyes with a refractive multifocal intraocular lens with minimal added power. Ophthalmology. 2009 Mar;116(3):401-8. Epub 2009 Jan 18.

Responsible Party:	Marcony R Santhiago, University of São Paulo
ClinicalTrials.gov Identifier:	NCT01027533 History of Changes
Other Study ID Numbers:	MRS.1703
Study First Received:	December 7, 2009
Last Updated:	July 1, 2010
Health Authority:	Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:

multifocal intraocular lens
visual acuity
presbiopia

ClinicalTrials.gov processed this record on May 19, 2013