This trial is active, not recruiting.

Conditions cataract, lens diseases, eye diseases
Sponsor Hospital Oftalmologico de Brasilia
Collaborator University of Sao Paulo
Start date January 2008
End date February 2016
Trial size 80 participants
Trial identifier NCT01763411, HOB-12/12, HOB03012013


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
No Intervention: Multifocal Spheric IOL implantation
No Intervention: Monofocal Spheric IOL implantation
No intervention Multifocal IOL implantation
No Intervention: Monofocal IOL implantation
No intervention Multifocal IOL implantation
No intervention Multifocal IOL implantation

Primary Outcomes

Visual Performance in Pseudophakic Patients With Different Intraocular Lens
time frame: 6 months postoperative

Secondary Outcomes

Contrast sensitivity
time frame: 6 months
Patient satisfaction
time frame: 6 months

Eligibility Criteria

Male or female participants from 55 years up to 85 years old.

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

Additional Information

Official title Visual Performance of Pseudophakic Patient With Different Intraocular Lenses
Principal investigator Wilson T Hida, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Hospital Oftalmologico de Brasilia.