CataractNCT04619654
Visual Outcomes With a Trifocal IOL in Subjects With Open-angle Glaucoma
A study testing Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold in people with Cataract and IOL, run by Vold Vision P.L.L.C at 1 site in United States.
Trial summary
This study will examine the visual outcomes of subjects undergoing cataract surgery and minimally invasive glaucoma surgery with the implantation of a trifocal intraocular lens. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cataract, IOL, Glaucoma, Open-Angle
- What is being tested?
- Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Jun 2022
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 45 years of age or older
- A visually significant cataract
- Diagnosis of mild OAG
- Vertical C/D ratio of less than or equal to 0.8
- VF characteristics consistent with glaucoma with mean deviation not worse than -6.00 dB and without fixation threatening scotoma AND/OR with nerve abnormalities consistent with glaucoma (rim notching, rim thinning, disc hemorrhage, nerve fiber layer loss)
- Medicated IOP 25 of less than or equal to mmHg on 1-3 medications
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- If treatment naïve (before glaucoma treatment) IOP between 21 and 35 mmHg
- Glaucoma must be judged as stable by investigator based on review of subject medical records
- Stable VF at least 1 year prior to surgery
- Stable nerve fiber layer at least 1 year prior to surgery
- IOP stable on current medication regimen at least 3 months prior to surgery
- Shaffer grade of greater than III in all quadrants
- Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logMAR (20/25) postoperatively
- Able and willing to comply with follow up visits
- Understands and signs the informed consent
Who cannot join
- Previous incisional glaucoma surgery or cilio-ablative surgery
- Prior laser trabeculoplasty within 90 days of surgery
- Pseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma.
- Moderate glaucoma with VF mean deviation between -6.00 dB and -12.00 dB
- Severe and/or progressive glaucoma defined as
- VF mean deviation worse than -12.00 dB
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- Consistent worsening of visual field on review of subject medical records
- Consistent and progressive thinning of nerve fiber layer on review of subject medical records
- Uncontrolled IOP on maximum glaucoma medications
- Historically poor IOP control with medical therapy
- Severe focal notching of the optic nerve rim
- Expectation for future need of incisional glaucoma surgery
- Ocular pathology or other medical condition which, in the investigator's judgment places the subject at increased risk of complications or significant vision loss during study period.
- Ocular pathology that in the investigator's judgment may impact visual acuity postoperatively, i.e. significant ocular surface disease, corneal scarring, blepharitis, epiretinal membrane, macular degeneration, history of significant ocular trauma with sequela, etc.
- Pregnant or breastfeeding women
- Prior refractive surgery e.g. LASIK, RK, PRK, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual Acuity, Refractive Predictability, and Patient Reported Quality of Vision in Subjects Implanted With a Trifocal IOL With Stable Mild Open-Angle Glaucoma Undergoing Concurrent Minimally Invasive Glaucoma Surgery
This study will examine the visual outcomes of subjects undergoing cataract surgery and minimally invasive glaucoma surgery with the implantation of a trifocal intraocular lens.
- Conditions
- Cataract, IOL, Glaucoma, Open-Angle
- Being tested
- Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold
- Keywords
- PanOptix, Trifocal IOL, Glaucoma, MIGS
- Medical subject headings
- Cataract, Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with implantation of trifocal IOL combined with trabecular scaffoldProcedure or surgery
Cataract surgery with implantation of the PanOptix IOL combined with minimally invasive glaucoma surgery utilizing the Hydrus Microstent
| Study group | Role | What they receive |
|---|---|---|
| Cataract Surgery with concurrent MIGS | Experimental | Not described Receives: Procedure: Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Measured: 3 months
Secondary outcomes (13)
Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR
Measured: 3 months
Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
Measured: 3 months
Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Measured: 3 months
Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR
Measured: 3 months
Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
Measured: 3 months
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Measured: 3 months
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR
Measured: 3 months
Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
Measured: 3 months
Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Measured: 3 months
Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR
Measured: 3 months
Mean Photopic Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
Measured: 3 months
Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar
Measured: 3 months
Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Feb 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single arm open label descriptive case series
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vold Vision P.L.L.C
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619654
- Sponsor's protocol ID
- PanOptix Trifocal 001, Rev A
- Status last verified
- May 2022
- First submitted
- 2 Nov 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Plan to publish results in open access peer reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Acuity, Refractive Predictability, and Patient Reported Quality of Vision in Subjects Implanted With a Trifocal IOL With Stable Mild Open-Angle Glaucoma Undergoing Concurrent Minimally Invasive Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT04619654
- Acronym / sponsor ID
- PanOptix Trifocal 001, Rev A
- Conditions
- Cataract, IOL, Glaucoma, Open-Angle
- Keywords
- PanOptix, Trifocal IOL, Glaucoma, MIGS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Vold Vision P.L.L.CUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 6 Nov 2020 (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 study will examine the visual outcomes of subjects undergoing cataract surgery and minimally invasive glaucoma surgery with the implantation of a trifocal intraocular lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single arm open label descriptive case series
| Arm | Type | Receives |
|---|---|---|
| Cataract Surgery with concurrent MIGS | Experimental | Procedure: Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female subjects 45 years of age or older
- A visually significant cataract
- Diagnosis of mild OAG
- Glaucoma must be judged as stable by investigator based on review of subject medical records
- Shaffer grade of greater than III in all quadrants
Key exclusion criteria (16 listed)
- Previous incisional glaucoma surgery or cilio-ablative surgery
- Prior laser trabeculoplasty within 90 days of surgery
- Pseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma.
- Moderate glaucoma with VF mean deviation between -6.00 dB and -12.00 dB
- Severe and/or progressive glaucoma defined as
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 |
|---|---|---|
| Cataract surgery with implantation of trifocal IOL combined with trabecular scaffoldCataract surgery with implantation of the PanOptix IOL combined with minimally invasive glaucoma surgery utilizing the Hydrus Microstent | Procedure or surgery | Cataract Surgery with concurrent MIGS |
Primary outcome
Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Time frame: 3 months
13 secondary outcomes
Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR
Time frame: 3 months
Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
Time frame: 3 months
Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Time frame: 3 months
Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR
Time frame: 3 months
Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
Time frame: 3 months
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Time frame: 3 months
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR
Time frame: 3 months
Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
Time frame: 3 months
Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Time frame: 3 months
Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR
Time frame: 3 months
Mean Photopic Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
Time frame: 3 months
Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar
Time frame: 3 months
Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar
Time frame: 3 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 2022.
- Individual participant dataSharing planned: No. Plan to publish results in open access peer reviewed journal
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold in people with Cataract and IOL, run by Vold Vision P.L.L.C at 1 site 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 15 inclusion and 16 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 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR (time frame: 3 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 2022.