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Visual Performance of Pseudophakic Patient With Different Intraocular Lenses (ETDRS)

H

Hospital Oftalmologico de Brasilia

Status

Unknown

Conditions

Cataract
Eye Diseases
Lens Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT01763411
HOB-12/12
HOB03012013 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 patients

Sex

All

Ages

55 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

80 participants in 6 patient groups

Multifocal Spheric Intraocular Lens (Restor SN60D3 IOL)
Description:
No Intervention: Multifocal Spheric IOL implantation
Monofocal Spheric Intraocular Lens (AcrySof SN60AT IOL)
Description:
No Intervention: Monofocal Spheric IOL implantation
Multifocal Aspheric Intraocular Lens (Tecnis ZMA00 IOL)
Description:
No intervention Multifocal IOL implantation
Monofocal Aspheric Intraocular Lens (AcrySof SN60WF IOL)
Description:
No Intervention: Monofocal IOL implantation
Multifocal Aspheric Intraocular Lens (Tecnis ZMB00 IOL)
Description:
No intervention Multifocal IOL implantation
Multifocal Spheric Intraocular Lens (Restor SN6AD1 IOL)
Description:
No intervention Multifocal IOL implantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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