Low VisionNCT04984590
Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects
A study testing IOPCL AMD MAG in people with Low Vision and Age Related Macular Degeneration, run by OnPoint Vision Inc at 1 site in United States.
Trial summary
This early feasibility study aims to improve near vision in subjects 55 years or older who have a clinical diagnosis of Age-Related Macular Degeneration. Subjects must have previously been implanted with either the Alcon Model SN60WF or Model SA60AT intraocular lens at least 6-months prior to receiving the IOPCL… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Vision, Age Related Macular Degeneration
- What is being tested?
- IOPCL AMD MAG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2022to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 55 years or older.
- Subjects who have already had cataract surgery with an Alcon SN60WF or SA60AT monofocal intraocular lens with a lens power between 17.0 diopters and 24.0 diopters clearly evidenced by photographic documentation by one of the following:
- patient medical record
- clinic chart with labeling attached
- surgical record with labeling attached, or
- patient identification card with make, model and serial number.
Show all 21Show fewer
- Subjects who have already had cataract surgery at least 6 months from the planned date of the IOPCL surgery.
- Subjects who have had a Nd: YAG capsulotomy at least 1 month prior to the planned date of the IOPCL surgery.
- Subjects with non-neovascular dry AMD meeting the following criteria:
- No change in Amsler Grid test within the past 12 months
- No subretinal fluid or macular hemorrhage confirmed by optical coherence tomography (OCT) imaging.
- No fundoscopic changes within the past 12 months (i.e., changes in retinal pigment epithelium).
- Subjects with best corrected distance visual acuity from 20/80 to 20/800.
- Subjects with a preoperative manifest refraction spherical equivalent (MRSE) of +1.0D to -1.0D.
- Subjects with ≤1.0D of corneal cylinder determined by keratometry readings.
- Subjects who are unsatisfied with their current near vision correction provided by either spectacles or external magnifier.
- Subjects who demonstrate at least 10 letters of near visual acuity improvement with the simulation/tolerance test (using manifest refraction with +7.0D add) compared to conventional near vision testing (using manifest refraction with +3.0D add).
- Subjects with a minimum endothelial cell count of 1800 cells/mm2.
- Subjects willing to abstain from pursuing any other surgical vision-correcting procedures for the duration of the study.
- Subjects who are willing and able to complete all required postoperative visits.
- Subjects who are able to comprehend and sign a statement of informed consent.
Who cannot join
- Subjects who have already had cataract surgery with a toric or multifocal or accommodating Intraocular Lens.
- Subjects who have already had cataract surgery with an Alcon SN60WF or SA60AT monofocal intraocular lens with a power below 17.0 diopters and greater than 24.0 diopters.
- Subjects with neovascular (wet) AMD.
- Subjects who have not had an Nd: YAG capsulotomy.
- Subjects who were treated with an IOL off-label.
- Subjects who have more than 1.0D of corneal cylinder determined by Keratometry readings.
Show all 28Show fewer
- Subjects whose continuous curvilinear capsulorhexis was less than 5mm or more than 6.0 mm in size at the time of IOL surgery.
- Subjects who had cataract surgery less than 6 months from the planned date of the IOPCL surgery.
- Subjects with anterior capsule fibrosis and phimosis that in the opinion of the investigator may confound the outcome or increase the risk to the subject.
- Subjects who do not gain at least 10 letters of near visual acuity with the simulation/tolerance testing (using manifest refraction with +7.0D add) compared to conventional near vision testing (using manifest refraction with +3.0D add).
- Subjects with a concomitant retinal or choroidal disorder other than AMD.
- Subjects with any corneal abnormality, other than regular corneal astigmatism that in the opinion of the investigator would confound the outcome(s) of the study.
- Subjects with clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy).
- Subjects with microphthalmos.
- Subjects with a previous retinal detachment.
- Subjects with a recurrent severe anterior or posterior segment inflammation of unknown etiology.
- Subjects with iris neovascularization.
- Subjects with glaucoma.
- Subjects with advanced visual field defects (e.g., central large scotoma where magnification would not help).
- Subjects with a fundus not visible.
- Subjects with aniridia.
- Subjects with advanced optic nerve atrophy.
- Subjects with damaged or incomplete zonules.
- Subjects with a known history of pseudoexfoliation.
- Subjects with acute, chronic or uncontrolled systemic or ocular disease that in the opinion of the investigator would increase the operative risk or confound the outcome(s) of the study.
- Subjects with medications that, in the opinion of the investigator, may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax)) or other medications with similar side effects (floppy iris syndrome).
- Subjects with cognitive impairment that may interfere with the ability to understand the potentially complex considerations underlying an informed decision on trial participation and/or interfere with the ability to neuro-adapt to this device in the postoperative period.
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Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Eye Associates
Laguna Hills, California, 92653
About this study
Official title: Early Feasibility Study to Evaluate the Safety and Effectiveness of the Intraoperative Pseudophakic Capsular Lens Magnifier for Age-Related Macular Degeneration (IOPCL AMD-MAG) for Secondary Implantation in the Capsular Bag to Improve Near Vision in Subjects With Age-Related Macular Degeneration After Cataract Surgery
This early feasibility study aims to improve near vision in subjects 55 years or older who have a clinical diagnosis of Age-Related Macular Degeneration. Subjects must have previously been implanted with either the Alcon Model SN60WF or Model SA60AT intraocular lens at least 6-months prior to receiving the IOPCL (intraocular pseudophakic capsular lens). Subject will be followed for a period of 12-months.
Read the detailed description
This will be a 12-month study, in which a maximum of 10 pseudophakic subjects from up to three clinical sites with a diagnosis of age-related macular degeneration will be enrolled. The IOPCL MAG (intraocular pseudophakic capsular lens magnifier) consists of a 4.5mm diameter optic. The IOPCL MAG is centered above the existing intraocular lens. The IOPCL MAG is designed to improve near vision of the AMD subject by providing magnification of 10 diopters in the central 1.8mm zone of the lens optic.
The primary objective of this study is to determine the stability of the IOPCL-AMD-MAG to successfully adhere to a pseudophakic intraocular lens (PCIOL) without slippage or rotation.
The secondary objective of this study is to determine if the IOPCL-AMD-MAG can improve uncorrected near vision in subjects previously implanted with the Alcon Models SN60WF or SA60AT.
Outcome simulation testing will be performed prior to the subject receiving the IOPCL. To qualify for the study the subject must demonstrate an improvement in uncorrected near visual acuity of 10 letters over baseline.
- Conditions
- Low Vision, Age Related Macular Degeneration
- Being tested
- IOPCL AMD MAG
- Medical subject headings
- Vision, Low, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOPCL AMD MAGDevice
The IOPCL MAG (intraocular pseudophakic capsular lens magnifier) consists of a 4.5 mm diameter optic. The central 1.8mm of the anterior surface has a power of 10.0 diopters. This IOPCL MAG will be implanted over an Alcon Model SN60WF or SA60AT intraocular lens to improve near vision.
| Study group | Role | What they receive |
|---|---|---|
| IOPCL AMD MAG | Other | All subjects will receive a 10.0 Diopter intraocular pseudophakic capsular lens magnifier (IOPCL MAG) Receives: Device: IOPCL AMD MAG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tilt of the PCIOL and IOPCL MAG Complex
Measuring postoperative tilt of the PCIOL and IOPCL MAG complex. Tilt was defined as less than or equal to 10 degrees.
Measured: 12 Months
IOPCL MAG Decentration
Measures the decentration of the IOPCL MAG against the PCIOL. Decentration was defined as the horizontal and vertical distances greater than or equal to 0.25mm or less than or equal to 0.75mm.
Measured: 12 Months
Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
Proportion of eyes (≥ 75%) able to achieve improvement of 10 letters or more of uncorrected near visual acuity (at 14 cm) at 12 months from baseline
Measured: 12 Months
Secondary outcomes (5)
Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)
Proportion of eyes (≥ 50%) able to achieve improvement of 20 letters or more of uncorrected near visual acuity (at 14 cm) at 12 months from baseline
Measured: 12 months
Postoperative Uncorrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 75% Achieving ≥ 10 Letters)
Proportion of eyes (≥ 75%) able to achieve improvement of 10 letters or more when comparing uncorrected near visual acuity (UCNVA) (at 14 cm) at 12 months from baseline BCNVA (at 30 cm, wearing the appropriate preoperative distance refractive correction in addition to +3.0D add)
Measured: 12 months
Postoperative Uncorrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 50% Achieving ≥ 20 Letters)
Proportion of eyes (≥ 50%) able to achieve improvement of 20 letters or more when comparing uncorrected near visual acuity (UCNVA) (at 14 cm) at 12 months from baseline BCNVA (at 30 cm, wearing the appropriate preoperative distance refractive correction in addition to +3.0D add)
Measured: 12 months
Postoperative Best Corrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 75% Achieving ≥ 10 Letters)
Proportion of eyes (≥ 75%) able to achieve improvement of 10 letters or more when comparing best corrected near visual acuity (BCNVA) (at 14 cm) at 12 months from baseline BCNVA (at 30 cm, wearing the appropriate preoperative distance refractive correction in addition to +3.0D add)
Measured: 12 months
Postoperative Best Corrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 50% Achieving ≥ 20 Letters)
Proportion of eyes (≥ 50%) able to achieve improvement of 20 letters or more when comparing best corrected near visual acuity (BCNVA) (at 14 cm) at 12 months from baseline BCNVA (at 30 cm, wearing the appropriate preoperative distance refractive correction in addition to +3.0D add)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start21 Jan 2022
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low VisionStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment with IOPCL AMD MAG at least 6-months after cataract surgery with Alcon Model SN60WF or SA60AT
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- OnPoint Vision Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984590
- Sponsor's protocol ID
- IOPCL AMD-20
- Status last verified
- Jan 2025
- First submitted
- 13 Jul 2021
- Last updated
- 31 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study to Evaluate the Safety and Effectiveness of the Intraoperative Pseudophakic Capsular Lens Magnifier for Age-Related Macular Degeneration (IOPCL AMD-MAG) for Secondary Implantation in the Capsular Bag to Improve Near Vision in Subjects With Age-Related Macular Degeneration After Cataract Surgery
- ClinicalTrials.gov ID
- NCT04984590
- Acronym / sponsor ID
- IOPCL AMD-20
- Conditions
- Low Vision, Age Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- OnPoint Vision IncIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Posted 19 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This early feasibility study aims to improve near vision in subjects 55 years or older who have a clinical diagnosis of Age-Related Macular Degeneration. Subjects must have previously been implanted with either the Alcon Model SN60WF or Model SA60AT intraocular lens at least 6-months prior to receiving the IOPCL (intraocular pseudophakic capsular lens). Subject will be followed for a period of 12-months.
Detailed description
This will be a 12-month study, in which a maximum of 10 pseudophakic subjects from up to three clinical sites with a diagnosis of age-related macular degeneration will be enrolled. The IOPCL MAG (intraocular pseudophakic capsular lens magnifier) consists of a 4.5mm diameter optic. The IOPCL MAG is centered above the existing intraocular lens. The IOPCL MAG is designed to improve near vision of the AMD subject by providing magnification of 10 diopters in the central 1.8mm zone of the lens optic.
The primary objective of this study is to determine the stability of the IOPCL-AMD-MAG to successfully adhere to a pseudophakic intraocular lens (PCIOL) without slippage or rotation.
The secondary objective of this study is to determine if the IOPCL-AMD-MAG can improve uncorrected near vision in subjects previously implanted with the Alcon Models SN60WF or SA60AT.
Outcome simulation testing will be performed prior to the subject receiving the IOPCL. To qualify for the study the subject must demonstrate an improvement in uncorrected near visual acuity of 10 letters over baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment with IOPCL AMD MAG at least 6-months after cataract surgery with Alcon Model SN60WF or SA60AT
| Arm | Type | Receives |
|---|---|---|
| IOPCL AMD MAG | Other | Device: IOPCL AMD MAGAll subjects will receive a 10.0 Diopter intraocular pseudophakic capsular lens magnifier (IOPCL MAG) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subjects aged 55 years or older.
- Subjects who have already had cataract surgery with an Alcon SN60WF or SA60AT monofocal intraocular lens with a lens power between 17.0 diopters and 24.0 diopters clearly evidenced by photographic documentation by one of the following:
- Subjects who have already had cataract surgery at least 6 months from the planned date of the IOPCL surgery.
- Subjects who have had a Nd: YAG capsulotomy at least 1 month prior to the planned date of the IOPCL surgery.
- Subjects with non-neovascular dry AMD meeting the following criteria:
Key exclusion criteria (28 listed)
- Subjects who have already had cataract surgery with a toric or multifocal or accommodating Intraocular Lens.
- Subjects who have already had cataract surgery with an Alcon SN60WF or SA60AT monofocal intraocular lens with a power below 17.0 diopters and greater than 24.0 diopters.
- Subjects with neovascular (wet) AMD.
- Subjects who have not had an Nd: YAG capsulotomy.
- Subjects who were treated with an IOL off-label.
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 |
|---|---|---|
| IOPCL AMD MAGThe IOPCL MAG (intraocular pseudophakic capsular lens magnifier) consists of a 4.5 mm diameter optic. The central 1.8mm of the anterior surface has a power of 10.0 diopters. This IOPCL MAG will be implanted over an Alcon Model SN60WF or SA60AT intraocular lens to improve near vision. | Device | IOPCL AMD MAG |
Primary outcome
Tilt of the PCIOL and IOPCL MAG Complex
Time frame: 12 Months
Measuring postoperative tilt of the PCIOL and IOPCL MAG complex. Tilt was defined as less than or equal to 10 degrees.
IOPCL MAG Decentration
Time frame: 12 Months
Measures the decentration of the IOPCL MAG against the PCIOL. Decentration was defined as the horizontal and vertical distances greater than or equal to 0.25mm or less than or equal to 0.75mm.
Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
Time frame: 12 Months
Proportion of eyes (≥ 75%) able to achieve improvement of 10 letters or more of uncorrected near visual acuity (at 14 cm) at 12 months from baseline
5 secondary outcomes
Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)
Time frame: 12 months
Postoperative Uncorrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 75% Achieving ≥ 10 Letters)
Time frame: 12 months
Postoperative Uncorrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 50% Achieving ≥ 20 Letters)
Time frame: 12 months
Postoperative Best Corrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 75% Achieving ≥ 10 Letters)
Time frame: 12 months
Postoperative Best Corrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 50% Achieving ≥ 20 Letters)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 IOPCL AMD MAG in people with Low Vision and Age Related Macular Degeneration, run by OnPoint Vision Inc 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 21 inclusion and 28 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 31 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tilt of the PCIOL and IOPCL MAG Complex (time frame: 12 Months). The study lists 3 primary outcomes in all. 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 31 Jan 2025.