CataractNCT02595177
Multifocal Intraocular Lens x Monovision x Hybrid Monovision After Bilateral Cataract Surgery
A study testing Cataract surgery with intraocular lens implantation. in people with Cataract and Presbyopia, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
To compare refractive outcomes and patient's visual quality after bilateral cataract surgery when implanting multifocal intraocular lens, monofocal with monovision or hybrid monovision. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- Cataract surgery with intraocular lens implantation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Sep 2015
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bilateral senile cataracts.
- Implantation of IOL in the capsular bag;
- Implants from 10-30 diopter;
- Potential Visual Acuity in ≥ 0.2 logMAR (20/32, metric scale) after surgery;
Who cannot join
- Amblyopia;
- Single Eye;
- History of intraocular surgery in the previous year;
- Sequel to prior ocular trauma;
- Important Microphthalmia or aniridia;
- History of damage to the corneal endothelium (chemical burns, herpetic keratitis, corneal guttata);
Show all 17Show fewer
- Corneal astigmatism > 1.0 D;
- IOP ≥ 21 mmHg in standard caliper;
- Ocular pathology that affects visual function (uveitis, diabetic retinopathy, age-related macular degeneration, macular dystrophy, retinal detachment, glaucoma, optic neuropathy);
- Pupil > 5 mm or < 2 mm under photopic conditions;
- Asymmetrical pupils in the eye or between the eyes;
- Binocular vision absence;
- Any situation that endangers the implant position in the capsular bag (post-traumatic zonular weakness, pseudoexfoliation, for example);
- Patient probably need to laser treatment of the retina;
- Patients whose expectations are unrealistic;
- Patients whose lifestyle involves high expectations of visual acuity (writer, driver, for example);
- Patients at risk of not meeting the clinical follow-up requirements (distance of travel difficulties, for example);
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Ophthalmology and Visual Sciences from the Federal University of Sao Paulo (UNIFESP)
São Paulo, São Paulo
About this study
Official title: Multifocal Intraocular Lens vs. Monovision vs. Hybrid Monovision After Bilateral Cataract Surgery
To compare refractive outcomes and patient's visual quality after bilateral cataract surgery when implanting multifocal intraocular lens, monofocal with monovision or hybrid monovision.
Read the detailed description
The purpose of this study is to evaluate the results in randomized patients that receive bilateral multifocal IOLs, monofocal IOLs with monovision with emmetropia in one eye and 1.50 D of myopia in the other eye, or monofocal IOL in the dominant eye and multifocal IOL in the non-dominant eye, then evaluate visual and refractive outcomes, as well as independence for glasses after bilateral surgery with 1 year of follow up.
- Conditions
- Cataract, Presbyopia
- Being tested
- Cataract surgery with intraocular lens implantation.
- Keywords
- multifocal IOL, monovision, hybrid monovision, spectacles independence
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with intraocular lens implantation.Procedure or surgery
Phacoemulsification under topical anesthesia with intraocular lens implantation.
| Study group | Role | What they receive |
|---|---|---|
| Multifocal IOL | Experimental | Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, multifocal intraocular lens implantation in both eyes planning for emmetropia complete the intervention. Receives: Procedure: Cataract surgery with intraocular lens implantation. |
| Monovision | Experimental | Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, a monofocal intraocular lens implantation planning for emmetropia in one eye (dominant) and a monofocal IOL planning for 1.50 D of myopia in the other eye (non-dominant) complete the intervention. Receives: Procedure: Cataract surgery with intraocular lens implantation. |
| Hybrid Monovision | Experimental | Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, a monofocal intraocular lens implantation in the dominant eye and a multifocal IOL in the non-dominant eye complete the intervention. Receives: Procedure: Cataract surgery with intraocular lens implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Binocular visual acuity in a semi-darkened room without correction to far, intermediate and near using a typical Snellen chart that is frequently used for visual acuity testing.
Measured: 1 year
Secondary outcomes (4)
Speed reading measure
Assessment is performed to measure the speed reading in each group and compare them. Then using a timer to measure how long does it take to read the page. The speed reading is measured in words per minute (WPM).
Measured: 1 year
Near stereopsis measure
Calculate stereopsis in each group and compare them. Stereoacuity is measured using a stereogram in which separate panels are shown to each eye.
Measured: 1 year
Contrast sensitivity measure
Comparison between groups of the contrast sensitivity. Contrast sensitivity function at five spatial frequencies is measured with the validated instrument (Functional Vision Analyzer® (Stereo Optical, Chicago, IL, USA) with best refraction.
Measured: 1 year
National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJul 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Joao Crispim, Federal University of São Paulo
- Investigators
- Joao Crispim, MD, Principal investigator, Post graduated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595177
- Sponsor's protocol ID
- PresbyIOL
- Status last verified
- Nov 2015
- First submitted
- 27 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifocal Intraocular Lens vs. Monovision vs. Hybrid Monovision After Bilateral Cataract Surgery
- ClinicalTrials.gov ID
- NCT02595177
- Acronym / sponsor ID
- PresbyIOL
- Conditions
- Cataract, Presbyopia
- Keywords
- multifocal IOL, monovision, hybrid monovision, spectacles independence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Alcon Research, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Nov 2015 (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.
To compare refractive outcomes and patient's visual quality after bilateral cataract surgery when implanting multifocal intraocular lens, monofocal with monovision or hybrid monovision.
Detailed description
The purpose of this study is to evaluate the results in randomized patients that receive bilateral multifocal IOLs, monofocal IOLs with monovision with emmetropia in one eye and 1.50 D of myopia in the other eye, or monofocal IOL in the dominant eye and multifocal IOL in the non-dominant eye, then evaluate visual and refractive outcomes, as well as independence for glasses after bilateral surgery with 1 year of follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multifocal IOL | Experimental | Procedure: Cataract surgery with intraocular lens implantation.Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, multifocal intraocular lens implantation in both eyes planning for emmetropia complete the intervention. |
| Monovision | Experimental | Procedure: Cataract surgery with intraocular lens implantation.Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, a monofocal intraocular lens implantation planning for emmetropia in one eye (dominant) and a monofocal IOL planning for 1.50 D of myopia in the other eye (non-dominant) complete the intervention. |
| Hybrid Monovision | Experimental | Procedure: Cataract surgery with intraocular lens implantation.Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, a monofocal intraocular lens implantation in the dominant eye and a multifocal IOL in the non-dominant eye complete the intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bilateral senile cataracts.
- Implantation of IOL in the capsular bag;
- Implants from 10-30 diopter;
- Potential Visual Acuity in ≥ 0.2 logMAR (20/32, metric scale) after surgery;
Key exclusion criteria (17 listed)
- Amblyopia;
- Single Eye;
- History of intraocular surgery in the previous year;
- Sequel to prior ocular trauma;
- Important Microphthalmia or aniridia;
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 |
|---|---|---|
| Cataract surgery with intraocular lens implantation.Phacoemulsification under topical anesthesia with intraocular lens implantation. | Procedure or surgery | Hybrid Monovision, Monovision, Multifocal IOL |
Primary outcome
Visual acuity
Time frame: 1 year
Binocular visual acuity in a semi-darkened room without correction to far, intermediate and near using a typical Snellen chart that is frequently used for visual acuity testing.
4 secondary outcomes
Speed reading measure
Time frame: 1 year
Near stereopsis measure
Time frame: 1 year
Contrast sensitivity measure
Time frame: 1 year
National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) questionnaire
Time frame: 1 year
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 3 Nov 2015.
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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.
Joao Crispim, MD principal investigator
Post graduated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery with intraocular lens implantation. in people with Cataract and Presbyopia, run by Federal University of São 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 4 inclusion and 17 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 3 Nov 2015. 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?
Visual acuity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2015.