CataractNCT05111106
Symfony Intraocular Lens Retrospective Chart Review
An observational study of Cataract, run by Austin Eye.
Trial summary
Retrospective chart review of patients with pre-existing ocular pathology who underwent cataract surgery with implantation of the Symfony IOL. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- Symfony IOL
- Type of treatment
- Medical device
- How many people
- 463 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2016to 31 Dec 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18-90 years old) in need of cataract surgery.
Who may be able to join
- :Phacoemulsification cataract surgery with a Symfony IOL.
Who cannot join
- : Eyes not implanted with a Symfony IOL or unstable refractive results at final post-operative visit
About this study
Official title: Experience With Symfony Extended Depth of Focus (EDOF) IOL: A Retrospective Chart Review
Retrospective chart review of patients with pre-existing ocular pathology who underwent cataract surgery with implantation of the Symfony IOL.
Read the detailed description
This was a retrospective chart review conducted at a single US clinical site. Chart review was conducted by John Odette, MD and research assistants. Eligible charts were identified via a clinic database search of cataract surgeries with IOL implantation of the Symfony IOL during the stated date range. Eligible charts included those of patients 18 to 90 years of age who underwent Femto Laser Assisted Cataract Surgery (FLACS) with implantation of a Symfony IOL. Charts were excluded for lack of postoperative follow-up or if Symfony IOL was not implanted. All qualifying patient charts were examined and further classified into 2 groups: (1) eyes with glaucoma; and 2) eyes without glaucoma. Visual acuity was evaluated for patients who underwent cataract surgery with implantation of the Symfony IOL from 09/1/2016 to 05/31/2018. Postoperative evaluations at Month 2 included mean monocular uncorrected visual acuity at near (UNVA) at 40 cm, far distance (UDVA) at 20 ft, and with best correction (CDVA). Outcomes were also compared for toric IOLs versus spherical IOL.
- Conditions
- Cataract
- Being tested
- Symfony IOL
- Keywords
- Cataract surgery, Glaucoma, Retinopathy, Intraocular Lens
- Medical subject headings
- Cataract, Glaucoma, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symfony IOLDevice
Implantation of Intraocular lens with extended depth of focus.
| Study group | Role | What they receive |
|---|---|---|
| Non-Pathology Eyes | Cataract Surgery with implantation of Symfony IOL in eyes without pre-existing pathology.. Receives: Device: Symfony IOL | |
| Glaucoma Eyes | Cataract Surgery with implantation of Symfony IOL with pre-existing glaucoma. Receives: Device: Symfony IOL | |
| Retinopathy Eyes | Cataract Surgery with implantation of Symfony IOL in eyes with pre-existing retinal pathology.. Receives: Device: Symfony IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular uncorrected near visual acuity
handheld near card (Jaeger scale)
Measured: 2 months
Secondary outcomes (1)
Monocular best corrected distance visual acuity
Snellen Chart at 20 feet
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start5 Oct 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, John Odette, Austin Eye
- Investigators
- John Odette, Principal investigator, Austin Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111106
- Sponsor's protocol ID
- AEJO-2018-Symfony
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- 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 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience With Symfony Extended Depth of Focus (EDOF) IOL: A Retrospective Chart Review
- ClinicalTrials.gov ID
- NCT05111106
- Acronym / sponsor ID
- AEJO-2018-Symfony
- Conditions
- Cataract
- Keywords
- Cataract surgery, Glaucoma, Retinopathy, Intraocular Lens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Austin EyeUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 8 Nov 2021 (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.
Retrospective chart review of patients with pre-existing ocular pathology who underwent cataract surgery with implantation of the Symfony IOL.
Detailed description
This was a retrospective chart review conducted at a single US clinical site. Chart review was conducted by John Odette, MD and research assistants. Eligible charts were identified via a clinic database search of cataract surgeries with IOL implantation of the Symfony IOL during the stated date range. Eligible charts included those of patients 18 to 90 years of age who underwent Femto Laser Assisted Cataract Surgery (FLACS) with implantation of a Symfony IOL. Charts were excluded for lack of postoperative follow-up or if Symfony IOL was not implanted. All qualifying patient charts were examined and further classified into 2 groups: (1) eyes with glaucoma; and 2) eyes without glaucoma. Visual acuity was evaluated for patients who underwent cataract surgery with implantation of the Symfony IOL from 09/1/2016 to 05/31/2018. Postoperative evaluations at Month 2 included mean monocular uncorrected visual acuity at near (UNVA) at 40 cm, far distance (UDVA) at 20 ft, and with best correction (CDVA). Outcomes were also compared for toric IOLs versus spherical IOL.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Pathology Eyes | – | Device: Symfony IOLCataract Surgery with implantation of Symfony IOL in eyes without pre-existing pathology.. |
| Glaucoma Eyes | – | Device: Symfony IOLCataract Surgery with implantation of Symfony IOL with pre-existing glaucoma. |
| Retinopathy Eyes | – | Device: Symfony IOLCataract Surgery with implantation of Symfony IOL in eyes with pre-existing retinal pathology.. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-90 years old) in need of cataract surgery.
Key inclusion criteria (1 listed)
- :Phacoemulsification cataract surgery with a Symfony IOL.
Key exclusion criteria (1 listed)
- : Eyes not implanted with a Symfony IOL or unstable refractive results at final post-operative visit
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 |
|---|---|---|
| Symfony IOLImplantation of Intraocular lens with extended depth of focus. | Device | Glaucoma Eyes, Non-Pathology Eyes, Retinopathy Eyes |
Primary outcome
Monocular uncorrected near visual acuity
Time frame: 2 months
handheld near card (Jaeger scale)
1 secondary outcome
Monocular best corrected distance visual acuity
Time frame: 2 months
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 8 Nov 2021.
- 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.
John Odette principal investigator
Austin Eye Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Austin Eye.
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 1 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 8 Nov 2021. 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 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?
Monocular uncorrected near visual acuity (time frame: 2 months). 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 8 Nov 2021.