22 and older, any sex, with Aphakia or Corneal Astigmatism. 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.
Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOLPrimary· Month 1 postoperative, Month 3 postoperative
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.
Month 1 postoperative
Group
Value
95% CI
HMTIOL
-0.50
± 0.95
Month 3 postoperative
Group
Value
95% CI
HMTIOL
-0.57
± 0.98
Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOLPrimary· Month 1 postoperative, Month 3 postoperative
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.
Month 1 postoperative
Group
Value
95% CI
HMTIOL
0.01
± 0.26
Month 3 postoperative
Group
Value
95% CI
HMTIOL
-0.03
± 0.29
Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOLPrimary· Baseline (Day 0 preoperative), Month 3 postoperative
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.
Group
Value
95% CI
HMTIOL
1.15
± 0.63
Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOLPrimary· Baseline (Day 0 preoperative), Month 3 postoperative
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 cylin
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.
Month 1 postoperative
Group
Value
95% CI
HMTIOL
0.14
± 0.41
Month 3 postoperative
Group
Value
95% CI
HMTIOL
0.26
± 0.43
Mean Absolute Misalignment of IOL Meridian - Target Versus Actual at Operative VisitPrimary· Day 0 (operative)
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.
Group
Value
95% CI
HMTIOL
2.6
± 1.7
Mean Absolute Rotation of IOL Meridian by VisitPrimary· Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
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.
Rotation from operative to Day 1 postoperative
Group
Value
95% CI
HMTIOL - Day 1 Postoperative
1.9
± 1.8
Rotation from operative to Week 1 postoperative
Group
Value
95% CI
HMTIOL - Day 1 Postoperative
2.3
± 1.6
Rotation from operative to Month 1 postoperative
Group
Value
95% CI
HMTIOL - Day 1 Postoperative
2.9
± 2.2
Rotation from operative to Month 3 postoperative
Group
Value
95% CI
HMTIOL - Day 1 Postoperative
2.4
± 2.3
Number of Eyes With Absolute Rotation of IOL Meridian by VisitPrimary· Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
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.
Rotation from operative ≤ 5 degrees
Group
Value
95% CI
HMTIOL - Day 1 Postoperative
12
HMTIOL - Week 1 Postoperative
12
HMTIOL - Month 1 Postoperative
12
HMTIOL - Month 3 Postoperative
12
Rotation from operative > 5 to ≤ 10 degrees
Group
Value
95% CI
HMTIOL - Day 1 Postoperative
1
HMTIOL - Week 1 Postoperative
1
HMTIOL - Month 1 Postoperative
1
HMTIOL - Month 3 Postoperative
1
Rotation from operative > 10 to ≤ 20 degrees
Group
Value
95% CI
HMTIOL - Day 1 Postoperative
0
HMTIOL - Week 1 Postoperative
0
HMTIOL - Month 1 Postoperative
0
HMTIOL - Month 3 Postoperative
0
Rotation from operative > 20 degrees
Group
Value
95% CI
HMTIOL - Day 1 Postoperative
0
HMTIOL - Week 1 Postoperative
0
HMTIOL - Month 1 Postoperative
0
HMTIOL - Month 3 Postoperative
0
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by VisitPrimary· Baseline (Day 0 preoperative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
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
20/20 Snellen or Better
Group
Value
95% CI
HMTIOL - Baseline (Day 0 Preoperative)
35.3
HMTIOL - Week 1 Postoperative
82.4
HMTIOL - Month 1 Postoperative
82.4
HMTIOL - Month 3 Postoperative
88.2
20/25 Snellen or Better
Group
Value
95% CI
HMTIOL - Baseline (Day 0 Preoperative)
47.1
HMTIOL - Week 1 Postoperative
88.2
HMTIOL - Month 1 Postoperative
94.1
HMTIOL - Month 3 Postoperative
88.2
20/32 Snellen or Better
Group
Value
95% CI
HMTIOL - Baseline (Day 0 Preoperative)
64.7
HMTIOL - Week 1 Postoperative
88.2
HMTIOL - Month 1 Postoperative
94.1
HMTIOL - Month 3 Postoperative
100.0
20/40 Snellen or Better
Group
Value
95% CI
HMTIOL - Baseline (Day 0 Preoperative)
64.7
HMTIOL - Week 1 Postoperative
94.1
HMTIOL - Month 1 Postoperative
94.1
HMTIOL - Month 3 Postoperative
100.0
Worse than 20/40 Snellen
Group
Value
95% CI
HMTIOL - Baseline (Day 0 Preoperative)
35.3
HMTIOL - Week 1 Postoperative
5.9
HMTIOL - Month 1 Postoperative
5.9
HMTIOL - Month 3 Postoperative
0.0
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by VisitPrimary· Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
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 20/4
20/20 Snellen or Better
Group
Value
95% CI
HMTIOL - Baseline (Day 0 Preoperative)
0.0
HMTIOL - Day 1 Postoperative
23.5
HMTIOL - Week 1 Postoperative
52.9
HMTIOL - Month 1 Postoperative
47.1
HMTIOL - Month 3 Postoperative
52.9
20/25 Snellen or Better
Group
Value
95% CI
HMTIOL - Baseline (Day 0 Preoperative)
5.9
HMTIOL - Day 1 Postoperative
35.3
HMTIOL - Week 1 Postoperative
76.5
HMTIOL - Month 1 Postoperative
70.6
HMTIOL - Month 3 Postoperative
76.5
20/32 Snellen or Better
Group
Value
95% CI
HMTIOL - Baseline (Day 0 Preoperative)
35.3
HMTIOL - Day 1 Postoperative
70.6
HMTIOL - Week 1 Postoperative
76.5
HMTIOL - Month 1 Postoperative
76.5
HMTIOL - Month 3 Postoperative
76.5
20/40 Snellen or Better
Group
Value
95% CI
HMTIOL - Baseline (Day 0 Preoperative)
47.1
HMTIOL - Day 1 Postoperative
82.4
HMTIOL - Week 1 Postoperative
88.2
HMTIOL - Month 1 Postoperative
88.2
HMTIOL - Month 3 Postoperative
88.2
Worse than 20/40 Snellen
Group
Value
95% CI
HMTIOL - Baseline (Day 0 Preoperative)
52.9
HMTIOL - Day 1 Postoperative
17.6
HMTIOL - Week 1 Postoperative
11.8
HMTIOL - Month 1 Postoperative
11.8
HMTIOL - Month 3 Postoperative
11.8
Number of Ocular Adverse Events Through Month 3Primary· Up to Month 3 postoperative
Ocular adverse events were identified as outlined in ISO 11979-2014 Annex B. No formal statistical hypothesis testing was planned.
Astigmatism
Group
Value
95% CI
HMTIOL
1
Ciliary zonular dehiscence
Group
Value
95% CI
HMTIOL
1
Intraocular injection
Group
Value
95% CI
HMTIOL
1
Macular oedema
Group
Value
95% CI
HMTIOL
1
Vitrectomy
Group
Value
95% CI
HMTIOL
1
Number of Device-Related Secondary Surgical Interventions (SSI) Other Than Optic Exchange and Rotational Adjustment of the HMTIOLPrimary· Up to Month 3 postoperative
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.
Group
Value
95% CI
HMTIOL
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from time of consent until study exit (up to 6 months)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study was to evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) in subjects with pre-existing corneal astigmatism in need of cataract surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ClarVista Medical
Last refreshed: 12 June 2020
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/NCT03050697.