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 range55 Years

SexALL

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.
✓. 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.
✕

What they're measuring

Tilt of the PCIOL and IOPCL MAG Complex

Timeframe: 12 Months

IOPCL MAG Decentration

Timeframe: 12 Months

Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)

Timeframe: 12 Months

Trial details

NCT IDNCT04984590

SponsorOnPoint Vision Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-20

Results submitted2024-10-24

View on ClinicalTrials.gov More Low Vision trials

Plain-language summary

Who can participate

Age range55 Years

SexALL

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.
✓. 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.
✕