Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects (NCT04984590) | Clinical Trial Compass
CompletedNot Applicable
Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects
United States9 participantsStarted 2022-01-21
Plain-language 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 (intraocular pseudophakic capsular lens). Subject will be followed for a period of 12-months.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Subjects with best corrected distance visual acuity from 20/80 to 20/800.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tilt of the PCIOL and IOPCL MAG Complex
Timeframe: 12 Months
2
IOPCL MAG Decentration
Timeframe: 12 Months
3
Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
. 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.
Exclusion criteria
. 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.
. 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.