Visual Outcomes After Implantation of a New Multifocal Intraocular Lens

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)

• Registration Number: NCT01505816
• Lead Sponsor: Hospital Oftalmologico de Brasilia

Brief Summary

This prospective nonrandomized study comprised patients with cataract, corneal astigmatism, and motivation for spectacle independence. In all cases, a Rayner M-flex® T toric Intraocular Lens will be implanted in the capsular bag. Three months postoperatively, distance, intermediate, and near visual acuities; spherical equivalent; residual refractive astigmatism; defocus curve; and contrast sensitivity will be evaluated. A patient-satisfaction and visual phenomena questionnaire will also be administered.

Detailed 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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2011-11
• Status Verified: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-06
• Last Update Submitted: 2012-01-06
• Study First Posted: 2012-01-09
• Last Update Posted: 2012-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Toric	Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)	Multifocal Toric IOL implantation

Primary Outcome Measures

Name	Time	Method
Visual Performance After Implantation of a Toric Multifocal Refractive Intraocular Lens	3 months postoperative	Postoperative evaluation will be performed at 3 months. The uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) will be assessed using the 100% contrast ETDRS chart; a binocular defocus curve will be constructed using the ETDRS chart at 4 m.

Secondary Outcome Measures

Name	Time	Method
Contrast sensitivity	3 months	Contrast sensitivity will be 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 (cpd). The background illumination of the translucent chart does not depend on room lighting. All measurements will be obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. The examinations will be performed unilaterally at a distance of 2.5 m with BCVA and an undilated pupil. All measurements will be performed under the same conditions.
Patient satisfaction	3 months	Patient satisfaction and quality of life will be assessed by a simple questionnaire. Patients will be interviewed 3 months postoperative. Patients will be asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure.

Trial Locations

Locations (1)

Hospital Oftalmologico Brasilia; 🇧🇷 Brasilia, DF, Brazil