Trial Outcomes & Findings for Evaluation of the Safety and Performance of the HARMONI® Toric Lens (NCT NCT03050697)
NCT ID: NCT03050697
Last Updated: 2020-06-12
Results Overview
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number, with a less negative number indicating a lesser amount of added correction. No formal statistical hypothesis testing was planned.
COMPLETED
NA
16 participants
Month 1 postoperative, Month 3 postoperative
2020-06-12
Participant Flow
Subjects were recruited from one investigative site located in New Zealand.
Of the 16 subjects (25 eyes) enrolled in the study, 4 subjects (7 eyes) were exited prior to implantation as screen failures, and 1 eye in 1 subject was exited prior to implantation due to a medical condition. This reporting group includes all implanted subjects (12) and eyes (17).
Unit of analysis: eyes
Participant milestones
| Measure |
HMTIOL
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|
|
Overall Study
STARTED
|
12 17
|
|
Overall Study
COMPLETED
|
12 17
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
Baseline characteristics by cohort
| Measure |
HMTIOL
n=12 Participants
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1 postoperative, Month 3 postoperativePopulation: Implanted Eye: All eyes with successful HMTIOL implantation and data at visit
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number, with a less negative number indicating a lesser amount of added correction. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL
Month 1 postoperative
|
-0.50 diopter
Standard Deviation 0.95
|
—
|
—
|
—
|
—
|
|
Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL
Month 3 postoperative
|
-0.57 diopter
Standard Deviation 0.98
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 postoperative, Month 3 postoperativePopulation: Implanted Eye: All eyes with successful HMTIOL implantation and data at visit
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. MRCYL PE was calculated as postoperative MRCYL adjusted to 6 meters minus MRCYL target residual refractive error (TRRE), with a lower absolute value indicating a more accurate cylinder power calculation. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL
Month 1 postoperative
|
0.01 diopter
Standard Deviation 0.26
|
—
|
—
|
—
|
—
|
|
Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL
Month 3 postoperative
|
-0.03 diopter
Standard Deviation 0.29
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 postoperative, Month 3 postoperativePopulation: Vector analyses (Eydelman 2006) based on the cylinder power and axis were planned but were not performed.
Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL PE is calculated as postoperative MRCYL adjusted to 6 meters minus MRCYL target residual refractive error (TRRE), with a lower absolute value indicating a more accurate cylinder power calculation. No formal statistical hypothesis testing was planned.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline (Day 0 preoperative), Month 3 postoperativePopulation: Implanted Eye: All eyes with successful HMTIOL implantation and data at visit
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL
|
1.15 diopter
Standard Deviation 0.63
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0 preoperative), Month 3 postoperativePopulation: Implanted Eye: All eyes with successful HMTIOL implantation and data at visit
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. Therefore, the cylindrical power percent reduction was the cylinder power reduction divided by the absolute value of preoperative magnitude of corneal cylinder (K) × 100. A higher number (greater percent reduction) indicates better astigmatism correction by the toric IOL. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=12 Participants
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL
|
76.2 percent reduction
Standard Deviation 27.4
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 postoperative, Month 3 postoperativePopulation: Implanted Eye: All eyes with successful HMTIOL implantation and data at visit
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). MRSE PE was calculated as postoperative MRSE adjusted to 6 meters minus MRSE target residual refractive error (TRRE). The lower the absolute number, the more accurate the IOL power calculation is. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)
Month 1 postoperative
|
0.14 diopter
Standard Deviation 0.41
|
—
|
—
|
—
|
—
|
|
Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)
Month 3 postoperative
|
0.26 diopter
Standard Deviation 0.43
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 (operative)Population: Implanted Eye: All eyes with successful HMTIOL implantation and data at visit
Absolute misalignment of IOL meridian was defined as the summation of IOL misplacement and IOL rotation. A lower number indicates minimal IOL misalignment. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Mean Absolute Misalignment of IOL Meridian - Target Versus Actual at Operative Visit
|
2.6 degrees
Standard Deviation 1.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperativePopulation: Implanted Eye: All eyes with successful HMTIOL implantation and data at visit
IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=13 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Mean Absolute Rotation of IOL Meridian by Visit
Rotation from operative to Day 1 postoperative
|
1.9 degrees
Standard Deviation 1.8
|
—
|
—
|
—
|
—
|
|
Mean Absolute Rotation of IOL Meridian by Visit
Rotation from operative to Week 1 postoperative
|
2.3 degrees
Standard Deviation 1.6
|
—
|
—
|
—
|
—
|
|
Mean Absolute Rotation of IOL Meridian by Visit
Rotation from operative to Month 1 postoperative
|
2.9 degrees
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
|
Mean Absolute Rotation of IOL Meridian by Visit
Rotation from operative to Month 3 postoperative
|
2.4 degrees
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperativePopulation: Implanted Eye: All eyes with successful HMTIOL implantation and data at visit. Analysis of IOL rotation was planned for rotation categories of ≤ 5°, \< 10°, \< 20°, and \< 30°. Instead, IOL rotation was reported for categories of ≤ 5°, \> 5° to ≤ 10°, \> 10° to ≤ 20°, and \> 20°.
IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=13 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
n=13 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
n=13 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
n=13 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Number of Eyes With Absolute Rotation of IOL Meridian by Visit
Rotation from operative ≤ 5 degrees
|
12 eyes
|
12 eyes
|
12 eyes
|
12 eyes
|
—
|
|
Number of Eyes With Absolute Rotation of IOL Meridian by Visit
Rotation from operative > 5 to ≤ 10 degrees
|
1 eyes
|
1 eyes
|
1 eyes
|
1 eyes
|
—
|
|
Number of Eyes With Absolute Rotation of IOL Meridian by Visit
Rotation from operative > 10 to ≤ 20 degrees
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
|
Number of Eyes With Absolute Rotation of IOL Meridian by Visit
Rotation from operative > 20 degrees
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0 preoperative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperativePopulation: Implanted Eye: All eyes with successful HMTIOL implantation and data at visit
Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. BCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit
20/20 Snellen or Better
|
35.3 percentage of eyes
|
82.4 percentage of eyes
|
82.4 percentage of eyes
|
88.2 percentage of eyes
|
—
|
|
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit
20/25 Snellen or Better
|
47.1 percentage of eyes
|
88.2 percentage of eyes
|
94.1 percentage of eyes
|
88.2 percentage of eyes
|
—
|
|
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit
20/32 Snellen or Better
|
64.7 percentage of eyes
|
88.2 percentage of eyes
|
94.1 percentage of eyes
|
100.0 percentage of eyes
|
—
|
|
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit
20/40 Snellen or Better
|
64.7 percentage of eyes
|
94.1 percentage of eyes
|
94.1 percentage of eyes
|
100.0 percentage of eyes
|
—
|
|
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit
Worse than 20/40 Snellen
|
35.3 percentage of eyes
|
5.9 percentage of eyes
|
5.9 percentage of eyes
|
0.0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperativePopulation: Implanted Eye: All eyes with successful HMTIOL implantation and data at visit
Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). UCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=12 Participants
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
n=12 Participants
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit
Worse than 20/40 Snellen
|
52.9 percentage of eyes
|
17.6 percentage of eyes
|
11.8 percentage of eyes
|
11.8 percentage of eyes
|
11.8 percentage of eyes
|
|
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit
20/20 Snellen or Better
|
0.0 percentage of eyes
|
23.5 percentage of eyes
|
52.9 percentage of eyes
|
47.1 percentage of eyes
|
52.9 percentage of eyes
|
|
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit
20/25 Snellen or Better
|
5.9 percentage of eyes
|
35.3 percentage of eyes
|
76.5 percentage of eyes
|
70.6 percentage of eyes
|
76.5 percentage of eyes
|
|
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit
20/32 Snellen or Better
|
35.3 percentage of eyes
|
70.6 percentage of eyes
|
76.5 percentage of eyes
|
76.5 percentage of eyes
|
76.5 percentage of eyes
|
|
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit
20/40 Snellen or Better
|
47.1 percentage of eyes
|
82.4 percentage of eyes
|
88.2 percentage of eyes
|
88.2 percentage of eyes
|
88.2 percentage of eyes
|
PRIMARY outcome
Timeframe: Day 0 operativePopulation: The planned sample size of 200 eyes was calculated based on the planned refinement of the A-Constant; however, due to the change in the study design, a sample size of 30 was targeted and a total of 17 eyes were implanted. Refinement of the A-Constant was planned, but not completed, due to the change in study design. No data was collected.
The A-constant (lens power constant) is a theoretical value that is used to calculate the power of the intraocular lens. It relates the lens power to the eye's axial length and keratometry. It is not expressed in units; it is specific to the design of the IOL and its intended location and orientation within the eye. A-constants are typically empirically developed for new IOLs based on hundreds of clinical uses. Data from a sufficient number of eyes are needed in order to reduce bias due to surgical technique, unusual eyes, and differences in equipment, such that the standard error of the mean in the lens power constant would be less than ±0.10 mm (approximately ±0.2 diopter). This study represented the first clinical use of the HMTIOL.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Month 3 postoperativePopulation: Safety Analysis: All eyes with attempted study lens implantation (successful or aborted after contact with the eye)
Ocular adverse events were identified as outlined in ISO 11979-2014 Annex B. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Number of Ocular Adverse Events Through Month 3
Ciliary zonular dehiscence
|
1 event
|
—
|
—
|
—
|
—
|
|
Number of Ocular Adverse Events Through Month 3
Intraocular injection
|
1 event
|
—
|
—
|
—
|
—
|
|
Number of Ocular Adverse Events Through Month 3
Macular oedema
|
1 event
|
—
|
—
|
—
|
—
|
|
Number of Ocular Adverse Events Through Month 3
Vitrectomy
|
1 event
|
—
|
—
|
—
|
—
|
|
Number of Ocular Adverse Events Through Month 3
Astigmatism
|
1 event
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Month 3 postoperativePopulation: Safety Analysis: All eyes with attempted study lens implantation (successful or aborted after contact with the eye)
A secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Number of Device-Related Secondary Surgical Interventions (SSI) Other Than Optic Exchange and Rotational Adjustment of the HMTIOL
|
1 SSI
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Month 3 postoperativePopulation: Safety Analysis: All eyes with attempted study lens implantation (successful or aborted after contact with the eye)
A device deficiency was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Number of Device Deficiencies Post Implantation
|
0 device deficiency
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 postoperative, Month 3 postoperativePopulation: Safety Analysis: All eyes with attempted study lens implantation (successful or aborted after contact with the eye)
Preservation of BCDVA was defined in terms of lines lost when reading the ETDRS chart at each visit compared to the prior best-achieved BCDVA. Loss of \< 1 line included subjects with less than a 1 line loss, no change or improvement in BCDVA. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
HMTIOL
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Week 1 Postoperative
n=17 eyes
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 1 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
HMTIOL - Month 3 Postoperative
HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
|
|---|---|---|---|---|---|
|
Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3
Loss < 1 line
|
16 eyes
|
16 eyes
|
—
|
—
|
—
|
|
Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3
Loss >= 1 line
|
1 eyes
|
1 eyes
|
—
|
—
|
—
|
|
Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3
Loss >= 2 lines
|
0 eyes
|
0 eyes
|
—
|
—
|
—
|
|
Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3
Loss >= 3 lines
|
0 eyes
|
0 eyes
|
—
|
—
|
—
|
|
Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3
Loss >= 4 lines
|
0 eyes
|
0 eyes
|
—
|
—
|
—
|
Adverse Events
HMTIOL - Nonocular AEs
HMTIOL - Ocular AEs
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HMTIOL - Nonocular AEs
n=12 participants at risk
All subjects with attempted study lens implantation (successful or aborted after contact with the eye)
|
HMTIOL - Ocular AEs
n=17 participants at risk
All eyes with attempted study lens implantation (successful or aborted after contact with the eye)
|
|---|---|---|
|
Eye disorders
Astigmatism
|
0.00%
0/12 • Adverse events were collected from time of consent until study exit (up to 6 months).
An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. "At Risk" population for ocular adverse events is reported with unit of eye.
|
5.9%
1/17 • Adverse events were collected from time of consent until study exit (up to 6 months).
An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. "At Risk" population for ocular adverse events is reported with unit of eye.
|
|
Eye disorders
Macular oedema
|
0.00%
0/12 • Adverse events were collected from time of consent until study exit (up to 6 months).
An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. "At Risk" population for ocular adverse events is reported with unit of eye.
|
5.9%
1/17 • Adverse events were collected from time of consent until study exit (up to 6 months).
An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. "At Risk" population for ocular adverse events is reported with unit of eye.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/12 • Adverse events were collected from time of consent until study exit (up to 6 months).
An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. "At Risk" population for ocular adverse events is reported with unit of eye.
|
5.9%
1/17 • Adverse events were collected from time of consent until study exit (up to 6 months).
An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. "At Risk" population for ocular adverse events is reported with unit of eye.
|
|
Surgical and medical procedures
Intra-ocular injection
|
0.00%
0/12 • Adverse events were collected from time of consent until study exit (up to 6 months).
An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. "At Risk" population for ocular adverse events is reported with unit of eye.
|
5.9%
1/17 • Adverse events were collected from time of consent until study exit (up to 6 months).
An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. "At Risk" population for ocular adverse events is reported with unit of eye.
|
|
Surgical and medical procedures
Vitrectomy
|
0.00%
0/12 • Adverse events were collected from time of consent until study exit (up to 6 months).
An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. "At Risk" population for ocular adverse events is reported with unit of eye.
|
5.9%
1/17 • Adverse events were collected from time of consent until study exit (up to 6 months).
An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. "At Risk" population for ocular adverse events is reported with unit of eye.
|
Additional Information
Sr. Clinical Trial Lead, CDMA Surgical
Alcon Research, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER