Clinical trial NCT01505816: Visual Outcomes After Implantation of a New Multifocal Intraocular Lens
Official title: Visual Outcomes After Implantation of a New Refractive Toric Multifocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Cataract
Vision
Intraocular lens
Multifocal
Toric
Lead sponsor: Hospital Oftalmologico de Brasilia
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2012-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Performance After Implantation of a Toric Multifocal Refractive Intraocular Lens
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Contrast sensitivity
timeFrame: 3 months
measure: Patient satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital Oftalmologico Brasilia
state: DF
Study officials:
affiliation: HOSPITAL OFTALMOLOGICO BRASILIA
name: PATRICK F TZELIKIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alio JL, Pinero DP, Tomas 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.
citation: Mojzis P, Pinero DP, Studeny P, Tomas J, Korda V, Plaza AB, Alio 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.
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 Sep 22.