Intraocular LensNCT03586271
Comparison of the Visual Performance After Implantation of Multifocal Lens
An observational study of Intraocular Lens, run by Aier School of Ophthalmology, Central South University at 1 site in China.
Trial summary
This is a prospective, consecutive, nonrandomized,comparative study. Comparison of the Visual Performance After Implantation of a Trifocal Intraocular Lens and Two Bifocal Intraocular Lenses Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Intraocular Lens
- What is being tested?
- trifocal lens, bifocal lens 1 and bifocal lens 2
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2018to 1 Feb 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cataract patients
Who may be able to join
- cataract
Who cannot join
- existence of any corneal disease;
- previous eye surgery;
- illiteracy;
- previous refractive surgery;
- expected postoperative corneal astigmatism more than 1.00D;
- higer-order aberration more than 0.3;
- spherical aberration more than 0.3μm;
- intraoperative or postoperative complications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wensheng Li
Shanghai, 200000
Hua Fan, +8618988761617 ext. +8618650424985, fanhua1116@163.com
Wensheng Li, +8618650424985 ext. +8618650424985, drlws@qq.com
About this study
Official title: Comparison of the Visual Performance After Implantation of a Trifocal Intraocular Lens(AT Lisa Tri 839MP) and Two Bifocal Intraocular Lenses(ReSTOR +2.5/+ 3.0D and Diff-aay)
This is a prospective, consecutive, nonrandomized,comparative study. Comparison of the Visual Performance After Implantation of a Trifocal Intraocular Lens and Two Bifocal Intraocular Lenses
Read the detailed description
Multifocal intraocular lenses were introduced in the 1980s and have the benefit of promoting near and far vision simultaneous. However, these multifocal lenses have the disadvantages, including lower contrast sensitivity(CS) and visual discomfort, such as halos, glares and starburst, et al. Therefore, careful patient selection is crucial to achieve good postoperative results. The purpose of this study was to compare the visual outcomes and subjective visual quality between bifocal intraocular Lens(ReSTOR +2.5/+ 3.0D and Diff-aay) and trifocal intraocular Lens(AT Lisa tri 839MP). This prospective, nonrandomized, consecutive, comparative study included the assessment of 60 patients implanted with multifocal intraocular lens. visual acuity was tested in all cases. Ophthalmological evaluation included the measurement of uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected near visual acuity (UNVA), and uncorrected intermediate visual acuity (UIVA), the analysis of contrast sensitivity (CS), visual defocus curve, spectacle independence, patient satisfaction, residual sphere, spherical equivalent (SE), cylinder and complications.
- Conditions
- Intraocular Lens
- Being tested
- trifocal lens, bifocal lens 1, bifocal lens 2, bifocal lens 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trifocal lensProcedure or surgery
phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation
bifocal lens 1Procedure or surgery
phacoemusification +bifocal lens(Diff-aay) implantation
bifocal lens 2Procedure or surgery
phacoemusification +bifocal lens (ReSTOR +3.0D) implantation
bifocal lens 3Procedure or surgery
phacoemusification +bifocal lens (ReSTOR +2.5D) implantation
| Study group | Role | What they receive |
|---|---|---|
| trifocal lens | trifocal lens implantation(AT Lisa tri 839MP) Receives: Procedure: bifocal lens 1; Procedure: bifocal lens 2; Procedure: bifocal lens 3 | |
| bifocal lens 1 | bifocal lens implantation(Diff-aay) Receives: Procedure: trifocal lens; Procedure: bifocal lens 2; Procedure: bifocal lens 3 | |
| bifocal lens 2 | bifocal lens implantation(ReSTOR +3.0D) Receives: Procedure: trifocal lens; Procedure: bifocal lens 1; Procedure: bifocal lens 3 | |
| bifocal lens 3 | bifocal lens implantation(ReSTOR +2.5D) Receives: Procedure: trifocal lens; Procedure: bifocal lens 1; Procedure: bifocal lens 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected distance visual acuity
Uncorrected distance visual acuity (4m) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).
Measured: 3 months after surgery
Uncorrected near visual acuity
Uncorrected near visual acuity (40cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).
Measured: 3 months after surgery
Uncorrected intermediate visual acuity
Uncorrected intermediate visual acuity (60cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start2 Aug 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraocular LensStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wensheng Li, Study director, Shanghai Aier Eye Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586271
- Sponsor's protocol ID
- SHIRB2018016
- Status last verified
- May 2018
- First submitted
- 15 Jun 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results
Publications
de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.
PubMed 29138533Gundersen KG, Potvin R. Comparison of visual outcomes after implantation of diffractive trifocal toric intraocular lens and a diffractive apodized bifocal toric intraocular lens. Clin Ophthalmol. 2016 Mar 17;10:455-61. doi: 10.2147/OPTH.S103375. eCollection 2016.
PubMed 27051269Xu Z, Cao D, Chen X, Wu S, Wang X, Wu Q. Comparison of clinical performance between trifocal and bifocal intraocular lenses: A meta-analysis. PLoS One. 2017 Oct 26;12(10):e0186522. doi: 10.1371/journal.pone.0186522. eCollection 2017.
PubMed 29073156
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Visual Performance After Implantation of a Trifocal Intraocular Lens(AT Lisa Tri 839MP) and Two Bifocal Intraocular Lenses(ReSTOR +2.5/+ 3.0D and Diff-aay)
- ClinicalTrials.gov ID
- NCT03586271
- Acronym / sponsor ID
- SHIRB2018016
- Conditions
- Intraocular Lens
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- 2 Aug 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 13 Jul 2018 (actual)
- 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 is a prospective, consecutive, nonrandomized,comparative study. Comparison of the Visual Performance After Implantation of a Trifocal Intraocular Lens and Two Bifocal Intraocular Lenses
Detailed description
Multifocal intraocular lenses were introduced in the 1980s and have the benefit of promoting near and far vision simultaneous. However, these multifocal lenses have the disadvantages, including lower contrast sensitivity(CS) and visual discomfort, such as halos, glares and starburst, et al. Therefore, careful patient selection is crucial to achieve good postoperative results. The purpose of this study was to compare the visual outcomes and subjective visual quality between bifocal intraocular Lens(ReSTOR +2.5/+ 3.0D and Diff-aay) and trifocal intraocular Lens(AT Lisa tri 839MP). This prospective, nonrandomized, consecutive, comparative study included the assessment of 60 patients implanted with multifocal intraocular lens. visual acuity was tested in all cases. Ophthalmological evaluation included the measurement of uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected near visual acuity (UNVA), and uncorrected intermediate visual acuity (UIVA), the analysis of contrast sensitivity (CS), visual defocus curve, spectacle independence, patient satisfaction, residual sphere, spherical equivalent (SE), cylinder and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| trifocal lens | – | Procedure: bifocal lens 1, Procedure: bifocal lens 2, Procedure: bifocal lens 3trifocal lens implantation(AT Lisa tri 839MP) |
| bifocal lens 1 | – | Procedure: trifocal lens, Procedure: bifocal lens 2, Procedure: bifocal lens 3bifocal lens implantation(Diff-aay) |
| bifocal lens 2 | – | Procedure: trifocal lens, Procedure: bifocal lens 1, Procedure: bifocal lens 3bifocal lens implantation(ReSTOR +3.0D) |
| bifocal lens 3 | – | Procedure: trifocal lens, Procedure: bifocal lens 1, Procedure: bifocal lens 2bifocal lens implantation(ReSTOR +2.5D) |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cataract patients
Key inclusion criteria (1 listed)
- cataract
Key exclusion criteria (8 listed)
- existence of any corneal disease;
- previous eye surgery;
- illiteracy;
- previous refractive surgery;
- expected postoperative corneal astigmatism more than 1.00D;
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 |
|---|---|---|
| trifocal lensphacoemusification + trifocal lens(AT Lisa tri 839MP) implantation | Procedure or surgery | bifocal lens 1, bifocal lens 2, bifocal lens 3 |
| bifocal lens 1phacoemusification +bifocal lens(Diff-aay) implantation | Procedure or surgery | bifocal lens 2, bifocal lens 3, trifocal lens |
| bifocal lens 2phacoemusification +bifocal lens (ReSTOR +3.0D) implantation | Procedure or surgery | bifocal lens 1, bifocal lens 3, trifocal lens |
| bifocal lens 3phacoemusification +bifocal lens (ReSTOR +2.5D) implantation | Procedure or surgery | bifocal lens 1, bifocal lens 2, trifocal lens |
Primary outcome
Uncorrected distance visual acuity
Time frame: 3 months after surgery
Uncorrected distance visual acuity (4m) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).
Uncorrected near visual acuity
Time frame: 3 months after surgery
Uncorrected near visual acuity (40cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).
Uncorrected intermediate visual acuity
Time frame: 3 months after surgery
Uncorrected intermediate visual acuity (60cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Background: PubMed 29138533de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.
- Background: PubMed 27051269Gundersen KG, Potvin R. Comparison of visual outcomes after implantation of diffractive trifocal toric intraocular lens and a diffractive apodized bifocal toric intraocular lens. Clin Ophthalmol. 2016 Mar 17;10:455-61. doi: 10.2147/OPTH.S103375. eCollection 2016.
- Background: PubMed 29073156Xu Z, Cao D, Chen X, Wu S, Wang X, Wu Q. Comparison of clinical performance between trifocal and bifocal intraocular lenses: A meta-analysis. PLoS One. 2017 Oct 26;12(10):e0186522. doi: 10.1371/journal.pone.0186522. eCollection 2017.
- Individual participant dataSharing planned: Yes. all IPD that underlie results
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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.
Wensheng Li study director
Shanghai Aier Eye Hosptial
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 Intraocular Lens, run by Aier School of Ophthalmology, Central South University at 1 site in China.
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 8 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 13 Jul 2018. 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 China. 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?
Contact Hua Fan (+8618988761617 ext. +8618988761617, fanhua1116@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected distance visual acuity (time frame: 3 months after surgery). The study lists 3 primary outcomes in all. 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 NCT03586271, which also lists 3 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 13 Jul 2018.