CataractETDRSNCT01763411
Visual Performance of Pseudophakic Patient With Different Intraocular Lenses
An observational study of Cataract and Lens Diseases, run by Hospital Oftalmologico de Brasilia at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract, Lens Diseases, Eye Diseases
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cataract, Lens Diseases, Eye Diseases
- Keywords
- Cataract, Vision, Intraocular lens, Multifocal, Monofocal
- Medical subject headings
- Cataract, Lens Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months postoperative
Secondary outcomes (2)
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startJan 2008
- Primary completionFeb 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Oftalmologico de Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Wilson Takashi Hida, Hospital Oftalmologico de Brasilia
- Investigators
- Wilson T Hida, MD, Principal investigator, University of Sao Paulo, BrazilNewton J Kara-Junior, MD PhD, Study chair, University of Sao Paulo, BrazilCelso T Nakano, MD, Principal investigator, University of Sao Paulo, BrazilPatrick Tzelikis, MD PhD, Study director, Hospital Oftalmologico de BrasiliaMario Augusto D Chaves, MD, Principal investigator, Hospital Oftalmologico de Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763411
- Sponsor's protocol ID
- HOB-12/12
- Other IDs
- HOB03012013
- Acronym
- ETDRS
- Status last verified
- Feb 2016
- First submitted
- 5 Jan 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19969209Alfonso 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.
PubMed 19787593Hida 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.
PubMed 19169507Chaves 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.
PubMed 27463628
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance of Pseudophakic Patient With Different Intraocular Lenses
- ClinicalTrials.gov ID
- NCT01763411
- Acronym / sponsor ID
- ETDRS / HOB-12/12
- Conditions
- Cataract, Lens Diseases, Eye Diseases
- Keywords
- Cataract, Vision, Intraocular lens, Multifocal, Monofocal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Oftalmologico de BrasiliaUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jan 2008
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Performance in Pseudophakic Patients With Different Intraocular Lens
Time frame: 6 months postoperative
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.
2 secondary outcomes
Contrast sensitivity
Time frame: 6 months
Patient satisfaction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Background: PubMed 19969209Kohnen 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.
- Background: PubMed 19787593Alfonso 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.
- Results publication: PubMed 19169507Hida 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.
- Derived from this study: PubMed 27463628Chaves 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilson T Hida, MD principal investigator
University of Sao Paulo, Brazil
Newton J Kara-Junior, MD PhD study chair
University of Sao Paulo, Brazil
Celso T Nakano, MD principal investigator
University of Sao Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Lens Diseases, run by Hospital Oftalmologico de Brasilia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Performance in Pseudophakic Patients With Different Intraocular Lens (time frame: 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01763411, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.