To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual AcuityNCT01027533
Visual Performance of New Apodized Diffractive Multifocal IOL With Addition of Plus Three
An observational study of To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual Acuity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of the study is to determine whether implantation of a multifocal IOL with a modified addition at lens plane(Restor +3) results in better intermediate visual acuity with similar performance at distance and near compared to other multifocal IOL with similar design but with higher addition at lens plane. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual Acuity
- What is being tested?
- Implantation of a multifocal Intraocular lens
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2009to Dec 2009
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sutdy population will be patients implanted bilaterally with the selected multifocal IOL
Who may be able to join
- •Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters)
Who cannot join
- Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities
- Surgical complications
- Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)
- Incomplete follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine whether implantation of a multifocal IOL with a modified addition at lens plane(Restor +3) results in better intermediate visual acuity with similar performance at distance and near compared to other multifocal IOL with similar design but with higher addition at lens plane. Patient's contrast sensitivity of vision and best reading distance following Restor +3 implantation were also assessed.
Study hypothesis: the implantation of an intraocular lens (IOL) with a modified addition at lens plane (restor +3, Alcon Laboratories,Inc) results in better intermediate visual acuity with similar distance and near visual acuity after cataract surgery.
Read the detailed description
Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.
Patients will be examined before surgery and at 1, 7, 30, 90 days and 3and 6 months after surgery.
- Being tested
- Implantation of a multifocal Intraocular lens
- Keywords
- multifocal intraocular lens, visual acuity, presbiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a multifocal Intraocular lensOther
Also called Restor + 3 SN6AD1, Restor + 4 SN6AD3
Bilateral implantation of a multifocal IOl
| Study group | Role | What they receive |
|---|---|---|
| Restor +3 | patients will be implanted bilaterally with Restor + 3 Receives: Other: Implantation of a multifocal Intraocular lens | |
| restor +4 | Patients will be implanted bilaterally with Restor +4 Receives: Other: Implantation of a multifocal Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
distance,intermediate and near visual acuity
Measured: 1, 3 and 6 months
Secondary outcomes (1)
reading speed and contrast sensitivity
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 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2009
- Study completionDec 2009
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 To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual AcuityStudies 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
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Marcony Santhiago, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027533
- Sponsor's protocol ID
- MRS.1703
- Status last verified
- Mar 2009
- First submitted
- 7 Dec 2009
- Last updated
- 2 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Gupta N, Wolffsohn JS, Naroo SA. Comparison of near visual acuity and reading metrics in presbyopia correction. J Cataract Refract Surg. 2009 Aug;35(8):1401-9. doi: 10.1016/j.jcrs.2009.03.026.
PubMed 19631128Biber JM, Sandoval HP, Trivedi RH, de Castro LE, French JW, Solomon KD. Comparison of the incidence and visual significance of posterior capsule opacification between multifocal spherical, monofocal spherical, and monofocal aspheric intraocular lenses. J Cataract Refract Surg. 2009 Jul;35(7):1234-8. doi: 10.1016/j.jcrs.2009.03.013.
PubMed 19545814Alfonso JF, Fernandez-Vega L, Amhaz H, Montes-Mico R, Valcarcel B, Ferrer-Blasco T. Visual function after implantation of an aspheric bifocal intraocular lens. J Cataract Refract Surg. 2009 May;35(5):885-92. doi: 10.1016/j.jcrs.2009.01.014.
PubMed 19393889Hayashi K, Yoshida M, Hayashi H. All-distance visual acuity and contrast visual acuity in eyes with a refractive multifocal intraocular lens with minimal added power. Ophthalmology. 2009 Mar;116(3):401-8. doi: 10.1016/j.ophtha.2008.09.052. Epub 2009 Jan 18.
PubMed 19152978
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance of New Apodized Diffractive Multifocal IOL With Addition of Plus Three
- ClinicalTrials.gov ID
- NCT01027533
- Acronym / sponsor ID
- MRS.1703
- Keywords
- multifocal intraocular lens, visual acuity, presbiopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Dec 2009 (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.
The purpose of the study is to determine whether implantation of a multifocal IOL with a modified addition at lens plane(Restor +3) results in better intermediate visual acuity with similar performance at distance and near compared to other multifocal IOL with similar design but with higher addition at lens plane. Patient's contrast sensitivity of vision and best reading distance following Restor +3 implantation were also assessed.
Study hypothesis: the implantation of an intraocular lens (IOL) with a modified addition at lens plane (restor +3, Alcon Laboratories,Inc) results in better intermediate visual acuity with similar distance and near visual acuity after cataract surgery.
Detailed description
Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.
Patients will be examined before surgery and at 1, 7, 30, 90 days and 3and 6 months after surgery.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restor +3 | – | Other: Implantation of a multifocal Intraocular lenspatients will be implanted bilaterally with Restor + 3 |
| restor +4 | – | Other: Implantation of a multifocal Intraocular lensPatients will be implanted bilaterally with Restor +4 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sutdy population will be patients implanted bilaterally with the selected multifocal IOL
Key inclusion criteria (1 listed)
- •Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters)
Key exclusion criteria (4 listed)
- Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities
- Surgical complications
- Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)
- Incomplete follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of a multifocal Intraocular lensAlso: Restor + 3 SN6AD1, Restor + 4 SN6AD3Bilateral implantation of a multifocal IOl | Other | Restor +3, restor +4 |
Primary outcome
distance,intermediate and near visual acuity
Time frame: 1, 3 and 6 months
1 secondary outcome
reading speed and contrast sensitivity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2010.
- Background: PubMed 19631128Gupta N, Wolffsohn JS, Naroo SA. Comparison of near visual acuity and reading metrics in presbyopia correction. J Cataract Refract Surg. 2009 Aug;35(8):1401-9. doi: 10.1016/j.jcrs.2009.03.026.
- Background: PubMed 19545814Biber JM, Sandoval HP, Trivedi RH, de Castro LE, French JW, Solomon KD. Comparison of the incidence and visual significance of posterior capsule opacification between multifocal spherical, monofocal spherical, and monofocal aspheric intraocular lenses. J Cataract Refract Surg. 2009 Jul;35(7):1234-8. doi: 10.1016/j.jcrs.2009.03.013.
- Background: PubMed 19393889Alfonso JF, Fernandez-Vega L, Amhaz H, Montes-Mico R, Valcarcel B, Ferrer-Blasco T. Visual function after implantation of an aspheric bifocal intraocular lens. J Cataract Refract Surg. 2009 May;35(5):885-92. doi: 10.1016/j.jcrs.2009.01.014.
- Background: PubMed 19152978Hayashi K, Yoshida M, Hayashi H. All-distance visual acuity and contrast visual acuity in eyes with a refractive multifocal intraocular lens with minimal added power. Ophthalmology. 2009 Mar;116(3):401-8. doi: 10.1016/j.ophtha.2008.09.052. Epub 2009 Jan 18.
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.
Marcony Santhiago, MD principal investigator
University of Sao Paulo
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 To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual Acuity, run by University of Sao Paulo 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 4 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: finished, as of the sponsor's last update on 2 Jul 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
distance,intermediate and near visual acuity (time frame: 1, 3 and 6 months). 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 NCT01027533, 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 2 Jul 2010.