Visual Outcomes After Implantation of a New Multifocal Intraocular Lens

Cataract Clinical Trial

Official title:

Visual Outcomes After Implantation of a New Refractive Toric Multifocal Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505816
• Other study ID #: HOB05
• Secondary ID: HOBBrasilia05
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2012
• Last updated: January 6, 2012
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Hospital Oftalmologico de Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)
Multifocal IOL implantation

Locations

Country	Name	City	State
Brazil	Hospital Oftalmologico Brasilia	Brasilia	DF

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Oftalmologico de Brasilia	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Alió JL, Piñero DP, Tomás J, Plaza AB. Vector analysis of astigmatic changes after cataract surgery with implantation of a new toric multifocal intraocular lens. J Cataract Refract Surg. 2011 Jul;37(7):1217-29. doi: 10.1016/j.jcrs.2010.12.064. — View Citation

Mojzis P, Piñero DP, Studeny P, Tomás J, Korda V, Plaza AB, Alió JL. Comparative analysis of clinical outcomes obtained with a new diffractive multifocal toric intraocular lens implanted through two types of corneal incision. J Refract Surg. 2011 Sep;27(9):648-57. doi: 10.3928/1081597X-20110506-01. Epub 2011 May 20. — View Citation

Visser N, Nuijts RM, de Vries NE, Bauer NJ. Visual outcomes and patient satisfaction after cataract surgery with toric multifocal intraocular lens implantation. J Cataract Refract Surg. 2011 Nov;37(11):2034-42. doi: 10.1016/j.jcrs.2011.05.041. Epub 2011 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Performance After Implantation of a Toric Multifocal Refractive Intraocular Lens	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.	3 months postoperative	Yes
Secondary	Contrast sensitivity	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.	3 months	No
Secondary	Patient satisfaction	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.	3 months	No