Visual Performance of Pseudophakic Patient With Different Intraocular Lenses
ETDRS
2 other identifiers
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 5, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 23, 2016
February 1, 2016
8.1 years
January 5, 2013
February 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Contrast sensitivity
6 months
Patient satisfaction
6 months
Study Arms (6)
Multifocal Spheric Intraocular Lens (Restor SN60D3 IOL)
No Intervention: Multifocal Spheric IOL implantation
Monofocal Spheric Intraocular Lens (AcrySof SN60AT IOL)
No Intervention: Monofocal Spheric IOL implantation
Multifocal Aspheric Intraocular Lens (Tecnis ZMA00 IOL)
No intervention Multifocal IOL implantation
Monofocal Aspheric Intraocular Lens (AcrySof SN60WF IOL)
No Intervention: Monofocal IOL implantation
Multifocal Aspheric Intraocular Lens (Tecnis ZMB00 IOL)
No intervention Multifocal IOL implantation
Multifocal Spheric Intraocular Lens (Restor SN6AD1 IOL)
No intervention Multifocal IOL implantation
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Oftalmologico de Brasilialead
- University of Sao Paulocollaborator
Study Sites (1)
University of Sao Paulo
São Paulo, São Paulo, 05403010, Brazil
Related Publications (4)
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.
PMID: 19969209BACKGROUNDAlfonso 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.
PMID: 19787593BACKGROUNDHida 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.
PMID: 19169507RESULTChaves 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.
PMID: 27463628DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Wilson T Hida, MD
University of Sao Paulo, Brazil
- STUDY CHAIR
Newton J Kara-Junior, MD PhD
University of Sao Paulo, Brazil
- PRINCIPAL INVESTIGATOR
Celso T Nakano, MD
University of Sao Paulo, Brazil
- STUDY DIRECTOR
Patrick Tzelikis, MD PhD
Hospital Oftalmologico de Brasilia
- PRINCIPAL INVESTIGATOR
Mario Augusto D Chaves, MD
Hospital Oftalmologico de Brasilia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
January 5, 2013
First Posted
January 8, 2013
Study Start
January 1, 2008
Primary Completion
February 1, 2016
Study Completion
December 1, 2016
Last Updated
February 23, 2016
Record last verified: 2016-02