Visual Performance of Pseudophakic Patient With Different Intraocular Lenses

Cataract Clinical Trial

— ETDRS  

Official title:

Visual Performance of Pseudophakic Patient With Different Intraocular Lenses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01763411
• Other study ID #: HOB-12/12
• Secondary ID: HOB03012013
• Status: Active, not recruiting
• Phase: N/A
• First received: January 5, 2013
• Last updated: February 21, 2016
• Start date: January 2008
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: Hospital Oftalmologico de Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: February 2016
• 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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cataract
• Eye Diseases
• Lens Diseases

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Oftalmologico de Brasilia	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Alfonso JF, Fernández-Vega L, Ortí S, Ferrer-Blasco T, Montés-Micó 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. — View Citation

Hida WT, Motta AF, Kara-José Júnior 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Performance in Pseudophakic Patients With Different Intraocular Lens	Postoperative evaluation was been performed at 6 months. The uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) was assessed using the 100% contrast ETDRS chart; a binocular defocus curve was constructed using the ETDRS chart at 4 m.	6 months postoperative	Yes
Secondary	Contrast sensitivity	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 (cpd). The background illumination of the translucent chart does not depend on room lighting. All measurements was obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. The examinations was performed unilaterally at a distance of 2.5 m with BCVA and an undilated pupil. All measurements was performed under the same conditions.	6 months	No
Secondary	Patient satisfaction	Patient satisfaction and quality of life was assessed by a simple questionnaire. Patients was interviewed 6 months postoperative. Patients was asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure.	6 months	No