Trial Outcomes & Findings for Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects (NCT NCT04984590)
NCT ID: NCT04984590
Last Updated: 2025-01-31
Results Overview
Measuring postoperative tilt of the PCIOL and IOPCL MAG complex. Tilt was defined as less than or equal to 10 degrees.
Recruitment status
COMPLETED
Target enrollment
9 participants
Primary outcome timeframe
12 Months
Results posted on
2025-01-31
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
IOPCL AMD MAG
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.
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Overall Study
STARTED
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9 9
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Overall Study
COMPLETED
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9 9
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Overall Study
NOT COMPLETED
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects
Baseline characteristics by cohort
| Measure |
IOPCL AMD MAG
n=9 Eyes
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.
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Age, Continuous
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83.2 Years
STANDARD_DEVIATION 5.78 • n=5 Participants
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Race/Ethnicity, Customized
Not of Hispanic, Latino/a, or Spanish origin
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9 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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9 Participants
n=5 Participants
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Region of Enrollment
United States
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9 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 12 MonthsMeasuring postoperative tilt of the PCIOL and IOPCL MAG complex. Tilt was defined as less than or equal to 10 degrees.
Outcome measures
| Measure |
IOPCL AMD MAG
n=9 Eyes
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.
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|---|---|
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Tilt of the PCIOL and IOPCL MAG Complex
PCIOL Tilt <= 10 degrees
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9 Eyes
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Tilt of the PCIOL and IOPCL MAG Complex
IOPCL MAG Tilt <=10 degrees
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9 Eyes
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PRIMARY outcome
Timeframe: 12 MonthsMeasures 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.
Outcome measures
| Measure |
IOPCL AMD MAG
n=9 Eyes
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.
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|---|---|
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IOPCL MAG Decentration
Number of eyes with IOPCL MAG horizontal and vertical distances >= 0.25mm and <=0.75mm
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9 Eyes
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IOPCL MAG Decentration
Number of eyes with IOPCL MAG horizontal and vertical distances < 0.25mm and >0.75mm
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0 Eyes
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PRIMARY outcome
Timeframe: 12 MonthsProportion 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
Outcome measures
| Measure |
IOPCL AMD MAG
n=9 Eyes
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.
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|---|---|
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
Gain of >= 20 letters (>= 4 lines)
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8 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
Gain of >= 15 letters (>= 3 lines)
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9 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
Gain of >= 10 letters (>= 2 lines)
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9 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
Gain of >= 5 letters (>= 1 line)
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9 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
No change
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0 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
Loss of >= 5 letters (>= 1 line)
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0 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
Loss of >=10 letters (>= 2 lines)
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0 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
Loss of >= 15 letters (>=3 lines)
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0 Eyes
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SECONDARY outcome
Timeframe: 12 monthsProportion 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
Outcome measures
| Measure |
IOPCL AMD MAG
n=9 Eyes
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.
|
|---|---|
|
Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)
Loss of >= 10 letters (>= 2 lines)
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0 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)
Loss of >= 15 letters (>= 3 lines)
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0 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)
Gain of >= 20 letters (>= 4 lines)
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8 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)
Gain of >= 15 letters (>= 3 lines)
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9 Eyes
|
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)
Gain of >= 10 letters (>= 2 lines)
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9 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)
Gain of >= 5 letters (>= 1 line)
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9 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)
No change
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0 Eyes
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Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)
Loss of >= 5 letters (>= 1 line)
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0 Eyes
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SECONDARY outcome
Timeframe: 12 monthsProportion 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)
Outcome measures
| Measure |
IOPCL AMD MAG
n=9 Eyes
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.
|
|---|---|
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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)
Gain of >= 20 letters (>= 4 lines)
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5 Eyes
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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)
Gain of >= 15 letters (>= 3 lines)
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8 Eyes
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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)
Gain of >= 10 letters (>= 2 lines)
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9 Eyes
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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)
Loss of >= 5 letters (>= 1 line)
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0 Eyes
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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)
Loss of >= 10 letters (>= 2 lines)
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0 Eyes
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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)
Loss of >= 15 letters (>= 3 lines)
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0 Eyes
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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)
Gain of >= 5 letters (>= 1 line)
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9 Eyes
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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)
No change
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0 Eyes
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SECONDARY outcome
Timeframe: 12 monthsProportion 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)
Outcome measures
| Measure |
IOPCL AMD MAG
n=9 Eyes
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.
|
|---|---|
|
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)
Gain of >= 20 letters (>= 4 lines)
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5 Eyes
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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)
Gain of >= 15 letters (>= 3 lines)
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8 Eyes
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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)
Loss of >= 15 letters (>= 3 lines)
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0 Eyes
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|
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)
Gain of >= 10 letters (>= 2 lines)
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9 Eyes
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|
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)
Gain of >= 5 letters (>= 1 line)
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9 Eyes
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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)
No change
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0 Eyes
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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)
Loss of >= 5 letters (>= 1 line)
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0 Eyes
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|
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)
Loss of >= 10 letters (>= 2 lines)
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0 Eyes
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SECONDARY outcome
Timeframe: 12 monthsProportion 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)
Outcome measures
| Measure |
IOPCL AMD MAG
n=9 Eyes
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.
|
|---|---|
|
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)
Gain of >= 20 letters (>= 4 lines)
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5 Eyes
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|
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)
Gain of >= 15 letters (>= 3 lines)
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8 Eyes
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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)
Gain of >= 10 letters (>= 2 lines)
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9 Eyes
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|
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)
Gain of >= 5 letters (>= 1 line)
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9 Eyes
|
|
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)
No change
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0 Eyes
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|
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)
Loss of >= 5 letters (>= 1 line)
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0 Eyes
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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)
Loss of >= 10 letters (>= 2 lines)
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0 Eyes
|
|
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)
Loss of >= 15 letters (>= 3 lines)
|
0 Eyes
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SECONDARY outcome
Timeframe: 12 monthsProportion 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)
Outcome measures
| Measure |
IOPCL AMD MAG
n=9 Eyes
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.
|
|---|---|
|
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)
Gain of >= 20 letters (>= 4 lines)
|
5 Eyes
|
|
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)
Gain of >= 15 letters (>= 3 lines)
|
8 Eyes
|
|
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)
Gain of >= 10 letters (>= 2 lines)
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9 Eyes
|
|
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)
Gain of >= 5 letters (>= 1 line)
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9 Eyes
|
|
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)
No change
|
0 Eyes
|
|
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)
Loss of >= 5 letters (>= 1 line)
|
0 Eyes
|
|
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)
Loss of >= 10 letters (>= 2 lines)
|
0 Eyes
|
|
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)
Loss of >= 15 letters (>= 3 lines)
|
0 Eyes
|
Adverse Events
IOPCL AMD MAG
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IOPCL AMD MAG
n=9 participants at risk
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.
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|---|---|
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Eye disorders
Bilateral pruritis
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11.1%
1/9 • Number of events 1 • 12 Months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place