CataractNCT03706066
India PanOptix Post Marketing Study
An observational study of Cataract, run by Alcon Research at 5 sites in India.
Trial summary
The purpose of this Post Marketing Study is to study the safety and effectiveness of the ACRYSOF IQ PanOptix intraocular lens (IOL) in an Indian population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Acrysof IQ PanOptix IOL and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 80 participants
- Where
- 5 sitesIndia
- Study dates
- 15 Jan 2019to 18 Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll males and females who are at least 18 years of age or older at the time of screening, have no ocular pathology that could confound study outcomes, have been advised bilateral cataract extraction, and desire an intraocular lens (IOL) that provides the potential for correction of near, intermediate, and distance vision.
Who may be able to join
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- Advised cataract extraction in both eyes and agreed for bilateral implantation of ACRYSOF IQ PanOptix lens;
- Preoperative regular keratometric astigmatism of ≤1.0 D in both eyes.
Who cannot join
- Pregnant or lactating, current or planned, during the course of the study;
- Retinal abnormalities (Macular Degeneration, dystrophy, edema , traction or other pathologies affecting vision);
- Clinically significant corneal abnormalities;
- History of retinal conditions;
- Previous refractive surgery, including LASIK;
- Glaucoma;
- Any condition that may not be appropriate to this study, as per the Investigator's expert medical opinion.
- Other protocol-specified inclusion and/or exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Alcon Investigative Site
Ahmedabad, Gujarat, 380052
Alcon Investigative Site
Bangalore, 560010
Alcon Investigative Site
Chennai, Tamil Nadu, 600006
Alcon Investigative Site
Coimbatore, Tamil Nadu, 641002
Alcon Investigative Site
Hyderabad, 500034
About this study
Official title: An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population
The purpose of this Post Marketing Study is to study the safety and effectiveness of the ACRYSOF IQ PanOptix intraocular lens (IOL) in an Indian population.
Read the detailed description
The study population will consist of adult Indian males and females, at least 18 years of age or older at the time of screening, with no ocular pathology that could confound study outcomes, who are advised bilateral cataract extraction and who desire an IOL that provides the potential for correction of near, intermediate, and distance vision. Both eyes will be implanted. The second eye surgery will take place 15-30 days after the first eye surgery. Subjects will be followed for approximately 3 months after the second eye surgery. Total individual subject participation will be approximately 4 months. This study will be conducted in India.
- Conditions
- Cataract
- Being tested
- Acrysof IQ PanOptix IOL, Cataract surgery
- 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 IOLDevice
Also called Model TFNT00
Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery
Cataract surgeryProcedure or surgery
Per investigator's standard of care
| Study group | Role | What they receive |
|---|---|---|
| PanOptix | Cataract surgery with implantation of Acrysof IQ PanOptix IOL Receives: Device: Acrysof IQ PanOptix IOL; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected binocular visual acuity at distance (4 m) at 3 months post bilateral implantation
Visual acuity will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and reported in logarithm minimum angle of resolution (logMAR).
Measured: Month 3 (following second eye surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start15 Jan 2019
- Primary completion18 Jan 2020
- Study completion18 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Alcon Laboratories (India) PVT.LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706066
- Sponsor's protocol ID
- ILD432-P001
- Other IDs
- CTRI/2018/11/016467
- Status last verified
- Feb 2020
- First submitted
- 11 Oct 2018
- Last updated
- 5 Feb 2020
- Results posted
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population
- ClinicalTrials.gov ID
- NCT03706066
- Acronym / sponsor ID
- ILD432-P001
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 18 Jan 2020 (actual)
- Study completion
- 18 Jan 2020 (actual)
- First posted
- 15 Oct 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.
The purpose of this Post Marketing Study is to study the safety and effectiveness of the ACRYSOF IQ PanOptix intraocular lens (IOL) in an Indian population.
Detailed description
The study population will consist of adult Indian males and females, at least 18 years of age or older at the time of screening, with no ocular pathology that could confound study outcomes, who are advised bilateral cataract extraction and who desire an IOL that provides the potential for correction of near, intermediate, and distance vision. Both eyes will be implanted. The second eye surgery will take place 15-30 days after the first eye surgery. Subjects will be followed for approximately 3 months after the second eye surgery. Total individual subject participation will be approximately 4 months. This study will be conducted in India.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PanOptix | – | Device: Acrysof IQ PanOptix IOL, Procedure: Cataract surgeryCataract surgery with implantation of Acrysof IQ PanOptix IOL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll males and females who are at least 18 years of age or older at the time of screening, have no ocular pathology that could confound study outcomes, have been advised bilateral cataract extraction, and desire an intraocular lens (IOL) that provides the potential for correction of near, intermediate, and distance vision.
Key inclusion criteria (3 listed)
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- Advised cataract extraction in both eyes and agreed for bilateral implantation of ACRYSOF IQ PanOptix lens;
- Preoperative regular keratometric astigmatism of ≤1.0 D in both eyes.
Key exclusion criteria (8 listed)
- Pregnant or lactating, current or planned, during the course of the study;
- Retinal abnormalities (Macular Degeneration, dystrophy, edema , traction or other pathologies affecting vision);
- Clinically significant corneal abnormalities;
- History of retinal conditions;
- Previous refractive surgery, including LASIK;
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 IOLAlso: Model TFNT00Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery | Device | PanOptix |
| Cataract surgeryPer investigator's standard of care | Procedure or surgery | PanOptix |
Primary outcome
Best corrected binocular visual acuity at distance (4 m) at 3 months post bilateral implantation
Time frame: Month 3 (following second eye surgery)
Visual acuity will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and reported in logarithm minimum angle of resolution (logMAR).
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 5 Feb 2020.
- 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.
Study Director study director
Alcon Laboratories (India) PVT.LTD
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Alcon Research at 5 sites in India.
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 3 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: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. 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?
Best corrected binocular visual acuity at distance (4 m) at 3 months post bilateral implantation (time frame: Month 3 (following second eye surgery)). 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 5 Feb 2020.