CataractsNCT02691741
Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)
A study testing AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL and AT LISA® tri IOL in people with Cataracts, run by Alcon Research.
Trial summary
The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL and AT LISA® tri IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- 29 Apr 2016to 17 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of bilateral cataracts with planned clear cornea cataract removal;
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- Calculated lens power between 13.0 and 30.0 Diopters (D);
- Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye;
- Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial;
- Preoperative regular corneal astigmatism of < 1.00 D, in both eyes;
- Clear intraocular media other than cataract in both eyes;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy);
- Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
- Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
- Amblyopia;
- Previous corneal transplant;
- Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction;
Show all 15Show fewer
- Rubella, congenital, traumatic, or complicated cataracts;
- Glaucoma (uncontrolled or controlled with medication);
- Degenerative eye disorders;
- History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy;
- Optic nerve atrophy;
- Expected to require retinal laser treatment;
- Color vision deficiencies;
- Pregnant or lactating (current or planned during the course of the study);
- Other protocol-specified exclusion criteria may apply.
About this study
Official title: Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal IOLs
The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.
Read the detailed description
Subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.
- Conditions
- Cataracts
- Being tested
- AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, AT LISA® tri IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOLDevice
Also called Model TFNT00
Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
AT LISA® tri IOLDevice
Also called Model 839MP
Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
| Study group | Role | What they receive |
|---|---|---|
| TFNT00 | Experimental | AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation Receives: Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL |
| 839MP | Active comparator | AT LISA® tri IOL, bilateral implantation Receives: Device: AT LISA® tri IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180
VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Measured: Day 120-180 from second eye implantation
Secondary outcomes (9)
Least Squares Mean Binocular UCIVA (60cm) at Day 120-180
VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Measured: Day 120-180 from second eye implantation
Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180
VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Measured: Day 120-180 from second eye implantation
Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180
VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Measured: Day 120-180 from second eye implantation
Mean Photopic Binocular Defocus Curve at Day 120-180
A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed.
Measured: Day 120-180 from second eye implantation
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Measured: Day 120-180 from second eye implantation
Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Measured: Day 120-180 from second eye implantation
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Measured: Day 120-180 from second eye implantation
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Measured: Day 120-180 from second eye implantation
Subject Satisfaction Recorded at Day 120-180
At the Month 6 Visit, subjects responded to the question: "Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?". Responses were reported as a percentage of subjects. No statistical test was performed.
Measured: Day 120-180 from second eye implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study start29 Apr 2016
- Primary completion17 Jul 2017
- Study completion17 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractsStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Manager, GCRA, Study director, Alcon, a Novartis Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691741
- Sponsor's protocol ID
- ILH297-P003
- Status last verified
- Sep 2019
- First submitted
- 22 Feb 2016
- Last updated
- 27 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal IOLs
- ClinicalTrials.gov ID
- NCT02691741
- Acronym / sponsor ID
- ILH297-P003
- Conditions
- Cataracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2016 (actual)
- Primary completion
- 17 Jul 2017 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Posted 27 Sep 2019
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 this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.
Detailed description
Subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TFNT00 | Experimental | Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOLAcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation |
| 839MP | Active comparator | Device: AT LISA® tri IOLAT LISA® tri IOL, bilateral implantation |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of bilateral cataracts with planned clear cornea cataract removal;
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- Calculated lens power between 13.0 and 30.0 Diopters (D);
- Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye;
- Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial;
Key exclusion criteria (15 listed)
- Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy);
- Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
- Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
- Amblyopia;
- Previous corneal transplant;
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 |
|---|---|---|
| AcrySof® IQ PanOptix™ Presbyopia-Correcting IOLAlso: Model TFNT00Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient | Device | TFNT00 |
| AT LISA® tri IOLAlso: Model 839MPTrifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient | Device | 839MP |
Primary outcome
Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180
Time frame: Day 120-180 from second eye implantation
VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
9 secondary outcomes
Least Squares Mean Binocular UCIVA (60cm) at Day 120-180
Time frame: Day 120-180 from second eye implantation
Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180
Time frame: Day 120-180 from second eye implantation
Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180
Time frame: Day 120-180 from second eye implantation
Mean Photopic Binocular Defocus Curve at Day 120-180
Time frame: Day 120-180 from second eye implantation
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
Time frame: Day 120-180 from second eye implantation
Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
Time frame: Day 120-180 from second eye implantation
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
Time frame: Day 120-180 from second eye implantation
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
Time frame: Day 120-180 from second eye implantation
Subject Satisfaction Recorded at Day 120-180
Time frame: Day 120-180 from second eye implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sr. Clinical Manager, GCRA study director
Alcon, a Novartis Company
Questions about this trial
What is this clinical trial studying?
A study testing AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL and AT LISA® tri IOL in people with Cataracts, run by Alcon Research.
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 8 inclusion and 15 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 27 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 27 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180 (time frame: Day 120-180 from second eye implantation). 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 27 Sep 2019.