Clinical trial NCT01763411: Visual Performance of Pseudophakic Patient With Different Intraocular Lenses
Official title: Visual Performance of Pseudophakic Patient With Different Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Lens Diseases
Eye Diseases
Keywords: Cataract
Vision
Intraocular lens
Multifocal
Monofocal
Lead sponsor: Hospital Oftalmologico de Brasilia
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2013-01-08
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was derived from patients who had phacoemulsification with multifocal or mono focal intraocular lens (IOL) in Sao Paulo University School of Medicine, Brazil. Patients with senile cataract with vision-impairing disease characterized by gradual, progressive opacity of the lens.

Brief summary: 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: 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 in Pseudophakic Patients With Different Intraocular Lens
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Contrast sensitivity
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo, Brazil
name: Wilson T Hida, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo, Brazil
name: Newton J Kara-Junior, MD PhD
role: STUDY_CHAIR
affiliation: University of Sao Paulo, Brazil
name: Celso T Nakano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Oftalmologico de Brasilia
name: Patrick Tzelikis, MD PhD
role: STUDY_DIRECTOR
affiliation: Hospital Oftalmologico de Brasilia
name: Mario Augusto D Chaves, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.