AphakiaNCT03050697
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
A study testing HARMONI® Modular Toric Intraocular Lens and Cataract extraction with intraocular lens (IOL) implantation in people with Aphakia and Corneal Astigmatism, run by ClarVista Medical at 1 site in New Zealand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aphakia, Corneal Astigmatism, Cataract
- What is being tested?
- HARMONI® Modular Toric Intraocular Lens and Cataract extraction with intraocular lens (IOL) implantation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNew Zealand
- Study dates
- 28 Sep 2016to 28 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned removal of visually significant bilateral cataract by manual phacoemulsification cataract extraction
- Pre-existing corneal astigmatism in at least 1 eye of 0.75 to 2.50 diopter (D)
- Target dioptric lens power within the range of 16 - 26 D
- Willing to discontinue contact lens wear for the duration of the study
- BCVA projected to be ≤0.2 logarithm minimum angle of resolution (LogMAR)
- Stable cornea
- Dilated pupil size at least 7.0 millimeters (mm)
- Able to understand and provide informed consent.
Who cannot join
- History of any intraocular or corneal surgery in study eye (including refractive)
- Pregnant or lactating
- History of any clinically significant retinal pathology or ocular diagnosis in study eye that could alter or limit final postoperative visual prognosis
- History of ocular conditions which could affect the stability of the IOL in study eye
- Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction in study eye
- Any visually significant intraocular media opacity other than cataract in study eye
Show all 10Show fewer
- Uncontrolled glaucoma in study eye
- Uncontrolled systemic disease
- Severe dry eye that would impair the ability to obtain reliable study measurements
- Systemic medication that may confound the outcome or increase the intraoperative and postoperative risk to the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter Study to Evaluate the Safety and Performance of the Exchangeable ClarVista HARMONI Modular Toric Intraocular Lens System for the Treatment of Pre-Existing Corneal Astigmatism and Aphakia Following Cataract Surgery
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.
Read the detailed description
Subjects with visually significant bilateral cataracts (cortical, nuclear, posterior subcapsular, or a combination) were implanted unilaterally (in one eye only) or bilaterally (in both eyes) with the HMTIOL. A total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of participation for each subject was up to 6 months, including the preoperative period (up to 3 months).
Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.
- Conditions
- Aphakia, Corneal Astigmatism, Cataract
- Being tested
- HARMONI® Modular Toric Intraocular Lens, Cataract extraction with intraocular lens (IOL) implantation
- Keywords
- Toric, Intraocular lens
- Medical subject headings
- Aphakia, Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HARMONI® Modular Toric Intraocular LensDevice
Also called HMTIOL
Two-component system consisting of a base and a separate toric optic
Cataract extraction with intraocular lens (IOL) implantationProcedure or surgery
Cataract removal via manual phacoemulsification, followed by HMTIOL implantation
| Study group | Role | What they receive |
|---|---|---|
| HMTIOL | Experimental | HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use Receives: Device: HARMONI® Modular Toric Intraocular Lens; Procedure: Cataract extraction with intraocular lens (IOL) implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL
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.
Measured: Month 1 postoperative, Month 3 postoperative
Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL
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.
Measured: Month 1 postoperative, Month 3 postoperative
MRCYL PE for Eyes Implanted With HMTIOL Per Vector Analyses
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.
Measured: Month 1 postoperative, Month 3 postoperative
Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL
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.
Measured: Baseline (Day 0 preoperative), Month 3 postoperative
Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL
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.
Measured: Baseline (Day 0 preoperative), Month 3 postoperative
Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)
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.
Measured: Month 1 postoperative, Month 3 postoperative
Mean Absolute Misalignment of IOL Meridian - Target Versus Actual at Operative 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.
Measured: Day 0 (operative)
Mean Absolute Rotation of IOL Meridian by 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.
Measured: Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Number of Eyes With Absolute Rotation of IOL Meridian by 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 and is reported categorically. No formal statistical hypothesis testing was planned.
Measured: Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by 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.
Measured: Baseline (Day 0 preoperative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by 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.
Measured: Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Standard Error of the Mean in Lens Power A-constant for Refinement
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.
Measured: Day 0 operative
Number of Ocular Adverse Events Through Month 3
Ocular adverse events were identified as outlined in ISO 11979-2014 Annex B. No formal statistical hypothesis testing was planned.
Measured: Up to Month 3 postoperative
Number of Device-Related Secondary Surgical Interventions (SSI) Other Than Optic Exchange and Rotational Adjustment of the HMTIOL
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.
Measured: Up to Month 3 postoperative
Number of Device Deficiencies Post Implantation
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.
Measured: Up to Month 3 postoperative
Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3
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.
Measured: Month 1 postoperative, Month 3 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start28 Sep 2016
- Primary completion7 Jun 2017
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- ClarVista Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Trial Lead, CDMA Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050697
- Sponsor's protocol ID
- CP-00004
- Status last verified
- Jun 2020
- First submitted
- 14 Sep 2016
- Last updated
- 12 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study to Evaluate the Safety and Performance of the Exchangeable ClarVista HARMONI Modular Toric Intraocular Lens System for the Treatment of Pre-Existing Corneal Astigmatism and Aphakia Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT03050697
- Acronym / sponsor ID
- CP-00004
- Conditions
- Aphakia, Corneal Astigmatism, Cataract
- Keywords
- Toric, Intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ClarVista MedicalIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects with visually significant bilateral cataracts (cortical, nuclear, posterior subcapsular, or a combination) were implanted unilaterally (in one eye only) or bilaterally (in both eyes) with the HMTIOL. A total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of participation for each subject was up to 6 months, including the preoperative period (up to 3 months).
Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HMTIOL | Experimental | Device: HARMONI® Modular Toric Intraocular Lens, Procedure: Cataract extraction with intraocular lens (IOL) implantationHARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Planned removal of visually significant bilateral cataract by manual phacoemulsification cataract extraction
- Pre-existing corneal astigmatism in at least 1 eye of 0.75 to 2.50 diopter (D)
- Target dioptric lens power within the range of 16 - 26 D
- Willing to discontinue contact lens wear for the duration of the study
- BCVA projected to be ≤0.2 logarithm minimum angle of resolution (LogMAR)
Key exclusion criteria (10 listed)
- History of any intraocular or corneal surgery in study eye (including refractive)
- Pregnant or lactating
- History of any clinically significant retinal pathology or ocular diagnosis in study eye that could alter or limit final postoperative visual prognosis
- History of ocular conditions which could affect the stability of the IOL in study eye
- Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction in study eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HARMONI® Modular Toric Intraocular LensAlso: HMTIOLTwo-component system consisting of a base and a separate toric optic | Device | HMTIOL |
| Cataract extraction with intraocular lens (IOL) implantationCataract removal via manual phacoemulsification, followed by HMTIOL implantation | Procedure or surgery | HMTIOL |
Primary outcome
Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL
Time frame: 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.
Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL
Time frame: 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.
MRCYL PE for Eyes Implanted With HMTIOL Per Vector Analyses
Time frame: Month 1 postoperative, Month 3 postoperative
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.
Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL
Time frame: 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.
Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL
Time frame: 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 cylinder (K) × 100. A higher number (greater percent reduction) indicates better astigmatism correction by the toric IOL. No formal statistical hypothesis testing was planned.
Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)
Time frame: Month 1 postoperative, Month 3 postoperative
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.
Mean Absolute Misalignment of IOL Meridian - Target Versus Actual at Operative Visit
Time frame: 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.
Mean Absolute Rotation of IOL Meridian by Visit
Time frame: 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.
Number of Eyes With Absolute Rotation of IOL Meridian by Visit
Time frame: 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.
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit
Time frame: 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 20/40 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.
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit
Time frame: 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 20/40 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.
Standard Error of the Mean in Lens Power A-constant for Refinement
Time frame: Day 0 operative
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.
Number of Ocular Adverse Events Through Month 3
Time frame: 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.
Number of Device-Related Secondary Surgical Interventions (SSI) Other Than Optic Exchange and Rotational Adjustment of the HMTIOL
Time frame: 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.
Number of Device Deficiencies Post Implantation
Time frame: Up to Month 3 postoperative
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.
Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3
Time frame: Month 1 postoperative, Month 3 postoperative
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sr. Clinical Trial Lead, CDMA Surgical study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HARMONI® Modular Toric Intraocular Lens and Cataract extraction with intraocular lens (IOL) implantation in people with Aphakia and Corneal Astigmatism, run by ClarVista Medical at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL (time frame: Month 1 postoperative, Month 3 postoperative). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.