Last reviewed · How we verify

NCT04984590

Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects

Completed Results posted Last updated 31 January 2025
What this trial tests

trial testing IOPCL AMD MAG in Low Vision in 9 participants. Completed in 20 March 2024.

Timeline
21 January 2022
Primary endpoint
20 March 2024
20 March 2024

Quick facts

Lead sponsorOnPoint Vision Inc
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date21 January 2022
Primary completion20 March 2024
Estimated completion20 March 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

OnPoint Vision Inc

Who can join

55 and older, any sex, with Low Vision or Age Related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tilt of the PCIOL and IOPCL MAG Complex Primary · 12 Months

Measuring postoperative tilt of the PCIOL and IOPCL MAG complex. Tilt was defined as less than or equal to 10 degrees.

PCIOL Tilt <= 10 degrees
GroupValue95% CI
IOPCL AMD MAG9
IOPCL MAG Tilt <=10 degrees
GroupValue95% CI
IOPCL AMD MAG9
IOPCL MAG Decentration Primary · 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.

Number of eyes with IOPCL MAG horizontal and vertical distances >= 0.25mm and <=0.75mm
GroupValue95% CI
IOPCL AMD MAG9
Number of eyes with IOPCL MAG horizontal and vertical distances < 0.25mm and >0.75mm
GroupValue95% CI
IOPCL AMD MAG0
Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters) Primary · 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

Gain of >= 20 letters (>= 4 lines)
GroupValue95% CI
IOPCL AMD MAG8
Gain of >= 15 letters (>= 3 lines)
GroupValue95% CI
IOPCL AMD MAG9
Gain of >= 10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG9
Gain of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG9
No change
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >=10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 15 letters (>=3 lines)
GroupValue95% CI
IOPCL AMD MAG0
Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters) Secondary · 12 months

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

Gain of >= 20 letters (>= 4 lines)
GroupValue95% CI
IOPCL AMD MAG8
Gain of >= 15 letters (>= 3 lines)
GroupValue95% CI
IOPCL AMD MAG9
Gain of >= 10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG9
Gain of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG9
No change
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 15 letters (>= 3 lines)
GroupValue95% CI
IOPCL AMD MAG0
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) Secondary · 12 months

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)

Gain of >= 20 letters (>= 4 lines)
GroupValue95% CI
IOPCL AMD MAG5
Gain of >= 15 letters (>= 3 lines)
GroupValue95% CI
IOPCL AMD MAG8
Gain of >= 10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG9
Gain of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG9
No change
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 15 letters (>= 3 lines)
GroupValue95% CI
IOPCL AMD MAG0
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) Secondary · 12 months

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)

Gain of >= 20 letters (>= 4 lines)
GroupValue95% CI
IOPCL AMD MAG5
Gain of >= 15 letters (>= 3 lines)
GroupValue95% CI
IOPCL AMD MAG8
Gain of >= 10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG9
Gain of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG9
No change
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 15 letters (>= 3 lines)
GroupValue95% CI
IOPCL AMD MAG0
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) Secondary · 12 months

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)

Gain of >= 20 letters (>= 4 lines)
GroupValue95% CI
IOPCL AMD MAG5
Gain of >= 15 letters (>= 3 lines)
GroupValue95% CI
IOPCL AMD MAG8
Gain of >= 10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG9
Gain of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG9
No change
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 15 letters (>= 3 lines)
GroupValue95% CI
IOPCL AMD MAG0
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) Secondary · 12 months

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)

Gain of >= 20 letters (>= 4 lines)
GroupValue95% CI
IOPCL AMD MAG5
Gain of >= 15 letters (>= 3 lines)
GroupValue95% CI
IOPCL AMD MAG8
Gain of >= 10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG9
Gain of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG9
No change
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 5 letters (>= 1 line)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 10 letters (>= 2 lines)
GroupValue95% CI
IOPCL AMD MAG0
Loss of >= 15 letters (>= 3 lines)
GroupValue95% CI
IOPCL AMD MAG0

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IOPCL AMD MAG
Serious: 0/9 (0%)
Deaths: 0/9
Other adverse events (1 terms — click to expand)

ReactionSystemIOPCL AMD MAG
Bilateral pruritisEye disorders

Data from ClinicalTrials.gov NCT04984590 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Low Vision

Currently open trials in the same condition.

Other OnPoint Vision Inc trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04984590.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing