CataractpresbyopiaNCT03454334
Visual Performance of Four Types of Multifocal Intraocular Lenses
A study testing multifocal intraocular lens IOLs in people with Cataract, run by Shahid Beheshti University.
Trial summary
This investigation assessed the visual performance of presbyopia and cataract patients after bilateral implantation of 4 distinct sorts of multifocal IOLs: At lisa tri, PanOptix, ReSTOR, and Symfony. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Cataract
- What is being tested?
- multifocal intraocular lens IOLs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2013to 14 Jan 2020
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative BCVA (distance) more impacted than 20/40
- Glare VA test comes about worse than 20/40, or practically impairing dissensions about their vision.
- By reviewing and judging the researchers, individuals also had a potential need for visual acuity of 20/30 or better after surgery.
- Express a want for multifocal vision, and be ready and ready to conform to the investigation necessities
Who cannot join
- Excluded from entry were subjects with regular astigmatism greater than 1.5 D or irregular astigmatism.
- Large pupil
- Corneal transplant surgery or previous glaucoma-filtering,
- A history of retinal detachments.
- Also excluded were patients with other clinically non-cataract ocular abnormality (e.g. chronic drug-induced miosis,
- Endothelial disease
- Iris neovascularization, and amblyopia)
About this study
Official title: To Compare the Clinical Results of Different Multifocal Intraocular Lenses (IOLs) in Patients With Presbyopia or Cataracts
This investigation assessed the visual performance of presbyopia and cataract patients after bilateral implantation of 4 distinct sorts of multifocal IOLs: At lisa tri, PanOptix, ReSTOR, and Symfony. The clinical results demonstrated here were excellent for four groups, however, there were also differences in group ReSTOR, UCVA and BCVA for the intermediate and near of the other groups showed less vision also symphony group for far distance demonstrated less vision than other groups, which may be related to their design.Multifocal IOLs demonstrated very good technology and unquestionably have a place in refractive surgery, whether for clear lens extraction or cataracts.Patients can expect excellent outcomes and surgeons can expect patients to be very satisfied with surgical outcomes. Four groups multifocal lenses provided excellent distance, intermediate and near vision, but several measures indicated that the PanOptix and at lisa tri lens provided better vision in all distances. Spectacle independence was significantly higher with four groups. Multifocal IOL design might play a role in the postsurgical outcome, because better results were obtained with diffractive lenses. Although there were differences in the results of these four lenses in the study, all of the results were acceptable.
- Conditions
- Cataract
- Being tested
- multifocal intraocular lens IOLs
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multifocal intraocular lens IOLsDevice
clinical outcome of different multifocal intraocular lenses (IOLs) in patients with presbyopia or cataracts
| Study group | Role | What they receive |
|---|---|---|
| AMO Tecnis Symfony | Active comparator | Multifocal with extended range of vision, Diffractive, No Preloaded, Aspheric, +3.25 D near add and +2.17 D intermediate 6.0mm Hydrophilic
-0.20
Has nine diffractive steps, The proprietary achromatic technology corrects chromatic aberration. This creates improved contrast sensitivity. Receives: Device: multifocal intraocular lens IOLs |
| AcrySof ReSTOR (Alcon Laboratories) | Active comparator | Multifocal ,Diffractive, +3.00D and for Near, Aspheric, Has 9 steps (rings), Light: 41% for far; 41% for near: 18% reflected (lost).
6.0mm Silicone
-0.10 Bifocal ,One piece,Blue filter ,Central diffractive region of 3.6_mm for near and distance vision ,Apodised ,peripheral refractive region is dedicated to distance vision Receives: Device: multifocal intraocular lens IOLs |
| AT Lisa tri (CarlZeiss Meditec AG) | Active comparator | Trifocal, diffractive, +3.33 D near add and +1.66 D intermediate add at the IOL plane, aspheric (aberration correcting) Optic Diameter 6.0 mm Total Diameter 11.0 mm Haptic Angulation 0° Lens Design Single-piece, MICS Incision Size 1.8 mm Company Labeled A-Constant1 118.6 Diopter Range 0.0 to +32.0 D, 0.5 D increments ACD 5.32 Receives: Device: multifocal intraocular lens IOLs |
| PanOptix(Alcon Laboratories) | Active comparator | Trifocal,Difractive,+3.25D Near,+2.17 D intermediate 6.0mm hydrophobic
-0.27 One piece ,aspheric , Focal 4.5 mm (15 diffractive zones) Receives: Device: multifocal intraocular lens IOLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast sensitivity
mean postoperative contrast sensitivity in logarithmic scale under binocular mesopic and photopic conditions. There was no significant difference in the values obtained between at lisa tri and PanOptix at spatial frequencies of 1 cpd and 3, 6, 12, 18 cpd. Eyes with the PanOptix and at lisa tri IOL showed better contrast sensitivity than ReSTOR and Symfony at spatial frequencies of 1, 3, 6 cpd (P<0.001) in photopic and mesopic conditions. The curves achieved with monocular vision were equivalent with binocular vision that was achieved.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start11 Aug 2013
- Primary completion18 Nov 2019
- Study completion14 Jan 2020
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, farinaz doroodgar, Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454334
- Sponsor's protocol ID
- ShahedBU
- Acronym
- presbyopia
- Status last verified
- Jun 2020
- First submitted
- 25 Jan 2018
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Clinical Results of Different Multifocal Intraocular Lenses (IOLs) in Patients With Presbyopia or Cataracts
- ClinicalTrials.gov ID
- NCT03454334
- Acronym / sponsor ID
- presbyopia / ShahedBU
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- 11 Aug 2013 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 5 Mar 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 investigation assessed the visual performance of presbyopia and cataract patients after bilateral implantation of 4 distinct sorts of multifocal IOLs: At lisa tri, PanOptix, ReSTOR, and Symfony. The clinical results demonstrated here were excellent for four groups, however, there were also differences in group ReSTOR, UCVA and BCVA for the intermediate and near of the other groups showed less vision also symphony group for far distance demonstrated less vision than other groups, which may be related to their design.Multifocal IOLs demonstrated very good technology and unquestionably have a place in refractive surgery, whether for clear lens extraction or cataracts.Patients can expect excellent outcomes and surgeons can expect patients to be very satisfied with surgical outcomes. Four groups multifocal lenses provided excellent distance, intermediate and near vision, but several measures indicated that the PanOptix and at lisa tri lens provided better vision in all distances. Spectacle independence was significantly higher with four groups. Multifocal IOL design might play a role in the postsurgical outcome, because better results were obtained with diffractive lenses. Although there were differences in the results of these four lenses in the study, all of the results were acceptable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AMO Tecnis Symfony | Active comparator | Device: multifocal intraocular lens IOLsMultifocal with extended range of vision, Diffractive, No Preloaded, Aspheric, +3.25 D near add and +2.17 D intermediate 6.0mm Hydrophilic -0.20 Has nine diffractive steps, The proprietary achromatic technology corrects chromatic aberration. This creates improved contrast sensitivity. |
| AcrySof ReSTOR (Alcon Laboratories) | Active comparator | Device: multifocal intraocular lens IOLsMultifocal ,Diffractive, +3.00D and for Near, Aspheric, Has 9 steps (rings), Light: 41% for far; 41% for near: 18% reflected (lost). 6.0mm Silicone -0.10 Bifocal ,One piece,Blue filter ,Central diffractive region of 3.6_mm for near and distance vision ,Apodised ,peripheral refractive region is dedicated to distance vision |
| AT Lisa tri (CarlZeiss Meditec AG) | Active comparator | Device: multifocal intraocular lens IOLsTrifocal, diffractive, +3.33 D near add and +1.66 D intermediate add at the IOL plane, aspheric (aberration correcting) Optic Diameter 6.0 mm Total Diameter 11.0 mm Haptic Angulation 0° Lens Design Single-piece, MICS Incision Size 1.8 mm Company Labeled A-Constant1 118.6 Diopter Range 0.0 to +32.0 D, 0.5 D increments ACD 5.32 |
| PanOptix(Alcon Laboratories) | Active comparator | Device: multifocal intraocular lens IOLsTrifocal,Difractive,+3.25D Near,+2.17 D intermediate 6.0mm hydrophobic -0.27 One piece ,aspheric , Focal 4.5 mm (15 diffractive zones) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Preoperative BCVA (distance) more impacted than 20/40
- Glare VA test comes about worse than 20/40, or practically impairing dissensions about their vision.
- By reviewing and judging the researchers, individuals also had a potential need for visual acuity of 20/30 or better after surgery.
- Express a want for multifocal vision, and be ready and ready to conform to the investigation necessities
Key exclusion criteria (7 listed)
- Excluded from entry were subjects with regular astigmatism greater than 1.5 D or irregular astigmatism.
- Large pupil
- Corneal transplant surgery or previous glaucoma-filtering,
- A history of retinal detachments.
- Also excluded were patients with other clinically non-cataract ocular abnormality (e.g. chronic drug-induced miosis,
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 |
|---|---|---|
| multifocal intraocular lens IOLsclinical outcome of different multifocal intraocular lenses (IOLs) in patients with presbyopia or cataracts | Device | AMO Tecnis Symfony, AT Lisa tri (CarlZeiss Meditec AG), AcrySof ReSTOR (Alcon Laboratories), PanOptix(Alcon Laboratories) |
Primary outcome
Contrast sensitivity
Time frame: 4 years
mean postoperative contrast sensitivity in logarithmic scale under binocular mesopic and photopic conditions. There was no significant difference in the values obtained between at lisa tri and PanOptix at spatial frequencies of 1 cpd and 3, 6, 12, 18 cpd. Eyes with the PanOptix and at lisa tri IOL showed better contrast sensitivity than ReSTOR and Symfony at spatial frequencies of 1, 3, 6 cpd (P<0.001) in photopic and mesopic conditions. The curves achieved with monocular vision were equivalent with binocular vision that was achieved.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing multifocal intraocular lens IOLs in people with Cataract, run by Shahid Beheshti University.
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 7 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: stopped early, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. 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?
Contrast sensitivity (time frame: 4 years). 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 18 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.