Visual Performance of Pseudophakic Patient With Different Intraocular Lenses

NCT ID: NCT01763411

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2016-12-31

Brief Summary

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This retrospective study comprised patients with cataract, corneal astigmatism, and motivation for spectacle independence. In all cases, a multifocal and monofocal Intraocular Lens was been implanted in the capsular bag. Three months postoperatively, distance, intermediate, and near visual acuities; spherical equivalent; residual refractive astigmatism; defocus curve; and contrast sensitivity was evaluated. A patient-satisfaction and visual phenomena questionnaire was also been administered.

Detailed Description

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Postoperative evaluation was performed at 3 months. The uncorrected and corrected distance visual acuity were assessed using the 100% contrast Early Treatment Diabetic Retinopathy Study chart, uncorrected intermediate visual acuity at 70 cm, and uncorrected near visual acuity at 40 cm; a binocular defocus curve was constructed using the ETDRS chart at 4 m and adding to the patient's manifest refraction +2.50 to -5.00 D sphere in 0.50 increments. The cylinder axis of the Intraocular lens (IOL) was measured at the slitlamp using the beam protractor after full mydriasis. The mean of the absolute values of degrees the intraocular lens was off axis was determined.

Contrast sensitivity was measured using the CSV-1000 HGT instrument (VectorVision, Inc.), which presents a translucent chart divided into 4 cycles with spatial frequencies of 3, 6, 12 and 18 cycles per degree. The background illumination of the translucent chart does not depend on room lighting. All measurements were obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. The examinations were performed unilaterally at a distance of 2.5 m with Best-corrected visual acuity (BCVA) and an undilated pupil. All measurements were performed under the same conditions.

Patient satisfaction and quality of life were assessed by a simple questionnaire. Patients were interviewed 3 months postoperative. Patients were asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure.

Conditions

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Cataract Lens Diseases Eye Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Multifocal Spheric Intraocular Lens (Restor SN60D3 IOL)

No Intervention: Multifocal Spheric IOL implantation

No interventions assigned to this group

Monofocal Spheric Intraocular Lens (AcrySof SN60AT IOL)

No Intervention: Monofocal Spheric IOL implantation

No interventions assigned to this group

Multifocal Aspheric Intraocular Lens (Tecnis ZMA00 IOL)

No intervention Multifocal IOL implantation

No interventions assigned to this group

Monofocal Aspheric Intraocular Lens (AcrySof SN60WF IOL)

No Intervention: Monofocal IOL implantation

No interventions assigned to this group

Multifocal Aspheric Intraocular Lens (Tecnis ZMB00 IOL)

No intervention Multifocal IOL implantation

No interventions assigned to this group

Multifocal Spheric Intraocular Lens (Restor SN6AD1 IOL)

No intervention Multifocal IOL implantation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Cataract Any race Either gender Diagnosis of cataracts both eyes Pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer Subjects must have \> 1.00 diopter of astigmatism

Exclusion Criteria

Central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia Retinal abnormalities Diabetes mellitus steroid or immunosuppressive treatment Connective tissue diseases
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

Hospital Oftalmologico de Brasilia

OTHER

Sponsor Role lead

Responsible Party

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Wilson Takashi Hida

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wilson T Hida, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo, Brazil

Newton J Kara-Junior, MD PhD

Role: STUDY_CHAIR

University of Sao Paulo, Brazil

Celso T Nakano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo, Brazil

Patrick Tzelikis, MD PhD

Role: STUDY_DIRECTOR

Hospital Oftalmologico de Brasilia

Mario Augusto D Chaves, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Oftalmologico de Brasilia

Locations

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University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Kohnen T, Nuijts R, Levy P, Haefliger E, Alfonso JF. Visual function after bilateral implantation of apodized diffractive aspheric multifocal intraocular lenses with a +3.0 D addition. J Cataract Refract Surg. 2009 Dec;35(12):2062-9. doi: 10.1016/j.jcrs.2009.08.013.

Reference Type BACKGROUND
PMID: 19969209 (View on PubMed)

Alfonso JF, Fernandez-Vega L, Orti S, Ferrer-Blasco T, Montes-Mico R. Refractive and visual results after implantation of the AcrySof ReSTOR IOL in high and low hyperopic eyes. Eur J Ophthalmol. 2009 Sep-Oct;19(5):748-53. doi: 10.1177/112067210901900511.

Reference Type BACKGROUND
PMID: 19787593 (View on PubMed)

Hida WT, Motta AF, Kara-Jose Junior N, Costa H, Tokunaga C, Cordeiro LN, Gemperli D, Nakano CT. [Comparison between OPD-Scan results and visual outcomes of Tecnis ZM900 and Restor SN60D3 diffractive multifocal intraocular lenses]. Arq Bras Oftalmol. 2008 Nov-Dec;71(6):788-92. doi: 10.1590/s0004-27492008000600004. Portuguese.

Reference Type RESULT
PMID: 19169507 (View on PubMed)

Chaves MA, Hida WT, Tzeliks PF, Goncalves MR, Nogueira Fde B, Nakano CT, Motta AF, Araujo AG, Alves MR. Comparative study on optical performance and visual outcomes between two diffractive multifocal lenses: AMO Tecnis (R) ZMB00 and AcrySof (R) IQ ReSTOR (R) Multifocal IOL SN6AD1. Arq Bras Oftalmol. 2016 May-Jun;79(3):171-6. doi: 10.5935/0004-2749.20160050.

Reference Type DERIVED
PMID: 27463628 (View on PubMed)

Other Identifiers

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HOB03012013

Identifier Type: OTHER

Identifier Source: secondary_id

HOB-12/12

Identifier Type: -

Identifier Source: org_study_id

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