Glaucoma, Open-AngleNCT05624398
Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery
A study testing Vivity IOL in people with Glaucoma, Open-Angle and Cataract, run by Vold Vision P.L.L.C at 1 site in United States.
Trial summary
This study is designed to determine how well patients with glaucoma can see following cataract surgery with a special type of lens called an extended-depth-of-focus (EDOF) lens. This lens is intended to reduced the patients need for glasses following cataract surgery. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Cataract
- What is being tested?
- Vivity IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2022to 1 May 2025
- 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 age-related cataract in both eyes
- Diagnosis of mild OAG
- 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 mmHg on 1-3 hypotensive medications
- Glaucoma must be judged as stable by investigator based on review of subject medical records
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- 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 ≥ III in all angle quadrants
- Potential of 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
- Both eyes of the subject should undergo surgery within 21 days of each other to ensure adequate timing for final visit window of 90 days ± 21 days post operatively
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.
- Subjects with significant complications during surgical procedure e.g., broken capsule, Hydrus Microstent complication, will be exited from the trial
- Subjects who experience visually significant complications related to the Hydrus Microstent during the study period will be exited from the trial
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vold Vision P.L.L.C.
Fayetteville, Arkansas, 72764
Michael R. M OD, 479-442-8653, mmcfarland@voldvision.com
About this study
Official title: Visual Outcomes and Patient Satisfaction in Subjects With Stable Open-angle Glaucoma Undergoing Concurrent Minimally Invasive Glaucoma Surgery and IOL Implantation With an Extended-depth-of-focus IOL
This study is designed to determine how well patients with glaucoma can see following cataract surgery with a special type of lens called an extended-depth-of-focus (EDOF) lens. This lens is intended to reduced the patients need for glasses following cataract surgery. Patients will also undergo a minimally invasive type of glaucoma surgery using a special type of stent to reduce eye pressure, with the goal of better glaucoma control and the reduction in the need for medications to control eye pressure.
Read the detailed description
To evaluate the range of vision and patient reported outcomes in subjects implanted with Clareon Vivity IOL undergoing concurrent MIGS with the Hydrus Microstent
- Conditions
- Glaucoma, Open-Angle, Cataract
- Being tested
- Vivity IOL
- Keywords
- Glaucoma, Cataract, Microstent, Premium IOL
- Medical subject headings
- Glaucoma, Open-Angle, Cataract, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivity IOLDevice
Also called Hydrus Microstent
Cataract surgery with implantation of the Vivity IOL along with concurrent implantation of the Hydrus Microstent
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Subjects implanted with the Vivity IOL undergoing concurrent implantation of the Hydrus Microstent Receives: Device: Vivity IOL |
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
Visual acuity measurement
Measured: 3 months
Secondary outcomes (10)
Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR
Visual acuity measurement
Measured: 3 months
Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Visual acuity measurement
Measured: 3 months
Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR
Visual acuity measurement
Measured: 3 months
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Visual acuity measurement
Measured: 3 months
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR
Visual acuity measurement
Measured: 3 months
Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Visual acuity measurement
Measured: 3 months
Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR
Visual acuity measurement
Measured: 3 months
Mean Refractive Spherical Equivalent
Average refractive error or residual spectacle prescription remaining following procedure (diopters)
Measured: 3 months
Mean Absolute Prediction Error
Average prescription remaining compared to preoperative prediction (diopters)
Measured: 3 months
Mean post-op refractive astigmatism and the distribution of post-op refractive astigmatism at ≤0.25D, ≤0.50D, ≤0.75D, and ≤1.00D
Examining the distribution or remaining astigmatism in subjects
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 posted22 Nov 2022
- Study start7 Dec 2022
- Primary completion1 Feb 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Prospective, single-center, single-surgeon, single-arm, descriptive study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
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
- NCT05624398
- Sponsor's protocol ID
- Vivity Protocol 001, Rev A
- Status last verified
- Aug 2024
- First submitted
- 6 Nov 2022
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The investigators do not plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes and Patient Satisfaction in Subjects With Stable Open-angle Glaucoma Undergoing Concurrent Minimally Invasive Glaucoma Surgery and IOL Implantation With an Extended-depth-of-focus IOL
- ClinicalTrials.gov ID
- NCT05624398
- Acronym / sponsor ID
- Vivity Protocol 001, Rev A
- Conditions
- Glaucoma, Open-Angle, Cataract
- Keywords
- Glaucoma, Cataract, Microstent, Premium IOL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Vold Vision P.L.L.CUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 22 Nov 2022 (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 is designed to determine how well patients with glaucoma can see following cataract surgery with a special type of lens called an extended-depth-of-focus (EDOF) lens. This lens is intended to reduced the patients need for glasses following cataract surgery. Patients will also undergo a minimally invasive type of glaucoma surgery using a special type of stent to reduce eye pressure, with the goal of better glaucoma control and the reduction in the need for medications to control eye pressure.
Detailed description
To evaluate the range of vision and patient reported outcomes in subjects implanted with Clareon Vivity IOL undergoing concurrent MIGS with the Hydrus Microstent
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, single-surgeon, single-arm, descriptive study
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Vivity IOLSubjects implanted with the Vivity IOL undergoing concurrent implantation of the Hydrus Microstent |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female subjects 45 years of age or older
- A visually significant age-related cataract in both eyes
- Diagnosis of mild OAG
- Glaucoma must be judged as stable by investigator based on review of subject medical records
- Shaffer grade of ≥ III in all angle quadrants
Key exclusion criteria (18 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 |
|---|---|---|
| Vivity IOLAlso: Hydrus MicrostentCataract surgery with implantation of the Vivity IOL along with concurrent implantation of the Hydrus Microstent | Device | Treatment Group |
Primary outcome
Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Time frame: 3 months
Visual acuity measurement
10 secondary outcomes
Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 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) (66 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) (66 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) (66 cm) logMAR
Time frame: 3 months
Mean Refractive Spherical Equivalent
Time frame: 3 months
Mean Absolute Prediction Error
Time frame: 3 months
Mean post-op refractive astigmatism and the distribution of post-op refractive astigmatism at ≤0.25D, ≤0.50D, ≤0.75D, and ≤1.00D
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No. The investigators do not plan to share IPD
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivity IOL in people with Glaucoma, Open-Angle and Cataract, 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 14 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 13 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 13 Aug 2024.