Cataract SurgeryNCT04146961
The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
An observational study of Cataract Surgery, run by Research Insight LLC at 3 sites in United States.
Trial summary
Prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Alcon PanOptix or PanOptix Toric IOL
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Oct 2019to 21 Jul 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The Investigators will collect patient-reported outcomes data on 60 new patients where both eyes receive either a PanOptix or PanOptix Toric lens, depending on the correction needed for each eye to eliminate astigmatism and achieve the target refraction. Both eyes will be targeted for emmetropia. Patients will be screened based on their candidacy for a multifocal implant.
Who may be able to join
- Patients implanted with the PanOptix or Panoptix Toric lenses bilaterally within 6 months of the survey administration. Patients may have the toric version of this lens in neither eye, one eye, or both eyes.
- Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
- Patients whose spherical equivalent outcome is within 0.5D of target and whose magnitude of manifest postoperative cylinder is less than or equal to 0.75 diopters.
Who cannot join
- Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
- Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered intraocular lens, cystoid macular edema, etc.)
- Patients with greater than grade 1 posterior capsule opacity.
- Patient sin the historical reference set who underwent Astigmatic Keratotomy or Limbal Relaxing Incision during cataract surgery. -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Quantum Vision Center
Edwardsville, Illinois, 62025-3886
Harvard Eye Associates
Laguna Hills, California, 92653
Quentin Allen
Palm City, Florida, 34990-1913
About this study
Prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes.
Read the detailed description
This will be an open-label, prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes, comparing to an existing historical dataset of patient reported outcomes with bilateral ReSTOR 3.0 implants.
- Conditions
- Cataract Surgery
- Being tested
- Alcon PanOptix or PanOptix Toric IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcon PanOptix or PanOptix Toric IOLDevice
Patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric IOL in both eyes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction, measured as the percentage of patients reporting "top box" satisfaction
Primary objective: to determine the percentage of patients who report "top box" (5 out of 5) overall satisfaction on the questionnaire instrument. To determine the percentage of patients who report satisfaction ("satisfied" or "very satisfied" as 4 out of 5 on the attached questionnaire instrument.
Measured: 6/1/20 - 7/1/20
Secondary outcomes (1)
Percentage of postoperative patients who report overall satisfaction as either "satisfied" or "very satisfied."
To report spectacle independence, measured as the percentage of patients who do not require glasses for each of the common activities queried like driving, reading, computer work, watching TV, and sports/hobbies. To determine the incidence of glare and halos described by the patient as "a fair amount" or worse (Question 20).
Measured: 6/1/20 - 7/1/20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start5 Oct 2019
- Primary completion10 Apr 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Insight LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Hovanesian, MD, Study director, Research Insight LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146961
- Sponsor's protocol ID
- ALC51819219
- Status last verified
- Jan 2020
- First submitted
- 28 Oct 2019
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
- ClinicalTrials.gov ID
- NCT04146961
- Acronym / sponsor ID
- ALC51819219
- Conditions
- Cataract Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Research Insight LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 31 Oct 2019 (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.
Prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes.
Detailed description
This will be an open-label, prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes, comparing to an existing historical dataset of patient reported outcomes with bilateral ReSTOR 3.0 implants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The Investigators will collect patient-reported outcomes data on 60 new patients where both eyes receive either a PanOptix or PanOptix Toric lens, depending on the correction needed for each eye to eliminate astigmatism and achieve the target refraction. Both eyes will be targeted for emmetropia. Patients will be screened based on their candidacy for a multifocal implant.
Key inclusion criteria (3 listed)
- Patients implanted with the PanOptix or Panoptix Toric lenses bilaterally within 6 months of the survey administration. Patients may have the toric version of this lens in neither eye, one eye, or both eyes.
- Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
- Patients whose spherical equivalent outcome is within 0.5D of target and whose magnitude of manifest postoperative cylinder is less than or equal to 0.75 diopters.
Key exclusion criteria (4 listed)
- Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
- Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered intraocular lens, cystoid macular edema, etc.)
- Patients with greater than grade 1 posterior capsule opacity.
- Patient sin the historical reference set who underwent Astigmatic Keratotomy or Limbal Relaxing Incision during cataract surgery. -
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 |
|---|---|---|
| Alcon PanOptix or PanOptix Toric IOLPatients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric IOL in both eyes. | Device | – |
Primary outcome
Satisfaction, measured as the percentage of patients reporting "top box" satisfaction
Time frame: 6/1/20 - 7/1/20
Primary objective: to determine the percentage of patients who report "top box" (5 out of 5) overall satisfaction on the questionnaire instrument. To determine the percentage of patients who report satisfaction ("satisfied" or "very satisfied" as 4 out of 5 on the attached questionnaire instrument.
1 secondary outcome
Percentage of postoperative patients who report overall satisfaction as either "satisfied" or "very satisfied."
Time frame: 6/1/20 - 7/1/20
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 30 Jul 2020.
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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.
John Hovanesian, MD study director
Research Insight LLC
3 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 Surgery, run by Research Insight LLC at 3 sites in United States.
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 4 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 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Satisfaction, measured as the percentage of patients reporting "top box" satisfaction (time frame: 6/1/20 - 7/1/20). 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 30 Jul 2020.