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 ComplexPrimary· 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
Group
Value
95% CI
IOPCL AMD MAG
9
IOPCL MAG Tilt <=10 degrees
Group
Value
95% CI
IOPCL AMD MAG
9
IOPCL MAG DecentrationPrimary· 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
Group
Value
95% CI
IOPCL AMD MAG
9
Number of eyes with IOPCL MAG horizontal and vertical distances < 0.25mm and >0.75mm
Group
Value
95% CI
IOPCL AMD MAG
0
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)
Group
Value
95% CI
IOPCL AMD MAG
8
Gain of >= 15 letters (>= 3 lines)
Group
Value
95% CI
IOPCL AMD MAG
9
Gain of >= 10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
9
Gain of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
9
No change
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >=10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 15 letters (>=3 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
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)
Group
Value
95% CI
IOPCL AMD MAG
8
Gain of >= 15 letters (>= 3 lines)
Group
Value
95% CI
IOPCL AMD MAG
9
Gain of >= 10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
9
Gain of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
9
No change
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 15 letters (>= 3 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
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)
Group
Value
95% CI
IOPCL AMD MAG
5
Gain of >= 15 letters (>= 3 lines)
Group
Value
95% CI
IOPCL AMD MAG
8
Gain of >= 10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
9
Gain of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
9
No change
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 15 letters (>= 3 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
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)
Group
Value
95% CI
IOPCL AMD MAG
5
Gain of >= 15 letters (>= 3 lines)
Group
Value
95% CI
IOPCL AMD MAG
8
Gain of >= 10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
9
Gain of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
9
No change
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 15 letters (>= 3 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
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)
Group
Value
95% CI
IOPCL AMD MAG
5
Gain of >= 15 letters (>= 3 lines)
Group
Value
95% CI
IOPCL AMD MAG
8
Gain of >= 10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
9
Gain of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
9
No change
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 15 letters (>= 3 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
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)
Group
Value
95% CI
IOPCL AMD MAG
5
Gain of >= 15 letters (>= 3 lines)
Group
Value
95% CI
IOPCL AMD MAG
8
Gain of >= 10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
9
Gain of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
9
No change
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 5 letters (>= 1 line)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 10 letters (>= 2 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
Loss of >= 15 letters (>= 3 lines)
Group
Value
95% CI
IOPCL AMD MAG
0
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.
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.
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Sponsor: as reported to ClinicalTrials.gov by OnPoint Vision Inc
Last refreshed: 31 January 2025
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.