CataractNCT03681886

Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)

A study testing Harmoni Modular Intraocular Lens and Optic Exchange in people with Cataract and Aphakia, run by ClarVista Medical.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study was to evaluate visual and refractive outcomes with the use of the HARMONI™ Modular Intraocular Lens (HMIOL) System implantation, assembly, and optic exchange in subjects undergoing cataract surgery. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataract, Aphakia
What is being tested?: Harmoni Modular Intraocular Lens and Optic Exchange
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: No sites listed yet
Study dates: 9 Jan 2016to 14 Dec 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

Able to understand and sign an approved Informed Consent Form (ICF);
Willing and able to return for scheduled treatment and follow-up examinations;
Planned removal of cataracts (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction;

Who cannot join

Any ocular conditions which could affect the stability of the IOL in either eye;
Traumatic or congenital cataract;
Pregnancy or planned pregnancy during the study period;
Medications that may confound the outcome or increase risk to the subject;
Any clinical finding or intraocular complication during primary cataract surgery or Implantation of the lens system likely to increase complications or risk to the subject;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Evaluation of Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System

Read the detailed description

All subjects were implanted with the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes based on the best interest of the subject and the clinical judgment the Investigator (Day 0, primary implantation) (Cohort 1). At Month 1 post primary implantation, subjects were given the option to undergo an optic exchange procedure. Subjects who underwent the optic exchange (Cohort 2) (Day 0, optic exchange) were followed for an additional month. Subjects who did not undergo an optic exchange were exited from the study, except at 1 site, which followed subjects up to Month 12.

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: Cataract, Aphakia
Being tested: Harmoni Modular Intraocular Lens, Optic Exchange
Keywords: intraocular lens, IOL, intraoperative exchange
Medical subject headings: Cataract, Aphakia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Harmoni Modular Intraocular LensDevice
Also called HMIOL
Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag.
Optic ExchangeProcedure or surgery
Removal of one optic and replacement with another for the purpose of improving refractive outcomes

Study groups in NCT03681886
Study group	Role	What they receive
Primary Implantation (Cohort 1)	Experimental	Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12. Receives: Device: Harmoni Modular Intraocular Lens
Optic Exchange (Cohort 2)	Experimental	Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange Receives: Device: Harmoni Modular Intraocular Lens; Procedure: Optic Exchange

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1
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 was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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: Day 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2
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 was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. The optic exchange occurred 1 month following primary implantation with HMIOL.
Measured: Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1
Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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 -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2
Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.
Measured: Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.
Measured: Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Measured: Day 0 primary implantation
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Measured: Day 0 primary implantation
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Measured: Day 0 post-exchange
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Measured: Day 0 post-exchange
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Measured: Day 0 post-exchange
Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange)
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, as determined by the investigator. No formal statistical hypothesis testing was planned.
Measured: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.
Number of Device Deficiencies
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: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jan 201614 Dec 2017

First posted24 Sep 2018
Study start9 Jan 2016
Primary completion14 Dec 2017
Study completion14 Dec 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 CataractStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03681886
Sponsor's protocol ID: CVM-00001
Status last verified: Dec 2020
First submitted: 20 Sep 2018
Last updated: 5 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus

All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System
ClinicalTrials.gov ID: NCT03681886
Acronym / sponsor ID: CVM-00001
Conditions: Cataract, Aphakia
Keywords: intraocular lens, IOL, intraoperative exchange
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: ClarVista MedicalIndustry (pharma, biotech, devices)
Study start: 9 Jan 2016 (actual)
Primary completion: 14 Dec 2017 (actual)
Study completion: 14 Dec 2017 (actual)
First posted: 24 Sep 2018 (actual)
Results: Posted 5 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Primary Implantation (Cohort 1)	Experimental	Device: Harmoni Modular Intraocular LensPrimary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Optic Exchange (Cohort 2)	Experimental	Device: Harmoni Modular Intraocular Lens, Procedure: Optic ExchangeSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Able to understand and sign an approved Informed Consent Form (ICF);
Willing and able to return for scheduled treatment and follow-up examinations;
Planned removal of cataracts (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction;

Key exclusion criteria (6 listed)

Any ocular conditions which could affect the stability of the IOL in either eye;
Traumatic or congenital cataract;
Pregnancy or planned pregnancy during the study period;
Medications that may confound the outcome or increase risk to the subject;
Any clinical finding or intraocular complication during primary cataract surgery or Implantation of the lens system likely to increase complications or risk to the subject;

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 Intraocular LensAlso: HMIOLTwo-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag.	Device	Optic Exchange (Cohort 2), Primary Implantation (Cohort 1)
Optic ExchangeRemoval of one optic and replacement with another for the purpose of improving refractive outcomes	Procedure or surgery	Optic Exchange (Cohort 2)

Primary outcome

Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1
Time frame: Day 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation
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 was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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 - Cohort 2
Time frame: Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange
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 was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. The optic exchange occurred 1 month following primary implantation with HMIOL.
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1
Time frame: Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation
Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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 Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2
Time frame: Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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.
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1
Time frame: Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2
Time frame: Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort
Time frame: Day 0 primary implantation
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort
Time frame: Day 0 primary implantation
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2
Time frame: Day 0 post-exchange
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2
Time frame: Day 0 post-exchange
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2
Time frame: Day 0 post-exchange
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange)
Time frame: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.
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, as determined by the investigator. No formal statistical hypothesis testing was planned.
Number of Device Deficiencies
Time frame: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.
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.

Results and safety

Results posted to the registry on 5 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All HMIOL Cohort	78	76

Primary outcome: Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1

Time frame: Day 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation. Number. Unit: percentage of eyes

Measure	Cohort 1 - Day 1 Post Primary Implantation n = 74	Cohort 1 - Week 1 Post Primary Implantation n = 75	Cohort 1 - Month 1 Post Primary Implantation n = 75	Cohort 1 - Month 3 Post Primary Implantation n = 12	Cohort 1 - Month 6 Post Primary Implantation n = 12	Cohort 1 - Month 12 Post Primary Implantation n = 12
20/20 Snellen or Better	30.2	32.0	32.0	16.7	58.3	25.0
20/25 Snellen or Better	53.1	61.9	60.8	58.3	83.3	50.0
20/32 Snellen or Better	74.0	84.5	78.4	91.7	91.7	66.7
20/40 Snellen or Better	85.4	89.7	93.8	91.7	100.0	100.0
Worse than 20/40 Snellen	14.6	10.3	6.2	3.3	0.0	0.0

Population analysed: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.

Primary outcome: Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2

Time frame: Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange. Number. Unit: percentage of eyes

Measure	Cohort 2 - Day 0 Pre Optic Exchange n = 3	Cohort 2 - Day 1 Post Optic Exchange n = 3	Cohort 2 - Week 1 Post Optic Exchange n = 3	Cohort 2 - Month 1 Post Optic Exchange n = 3
20/20 Snellen or Better	0.0	66.7	66.7	66.7
20/25 Snellen or Better	0.0	66.7	66.7	66.7
20/32 Snellen or Better	0.0	66.7	100.0	100.0
20/40 Snellen or Better	66.7	100.0	100.0	100.0
Worse than 20/40 Snellen	33.3	0.0	0.0	0.0

Population analysed: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.

Primary outcome: Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1

Time frame: Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation. Number. Unit: percentage of eyes

Measure	Cohort 1 - Baseline (Day -90 to Day 0 Preoperative) n = 71	Cohort 1 - Week 1 Post Primary Implantation n = 75	Cohort 1 - Month 1 Post Primary Implantation n = 75	Cohort 1 - Month 3 Post Primary Implantation n = 12	Cohort 1 - Month 6 Post Primary Implantation n = 12	Cohort 1 - Month 12 Post Primary Implantation n = 12
20/20 Snellen or Better	13.0	76.3	72.2	83.3	91.7	58.3
20/25 Snellen or Better	23.9	83.5	92.8	100.0	100.0	91.7
20/32 Snellen or Better	44.6	94.8	96.9	100.0	100.0	100.0
20/40 Snellen or Better	58.7	96.9	99.0	100.0	100.0	100.0
Worse than 20/40 Snellen	41.3	3.1	1.0	0.0	0.0	0.0

Population analysed: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.

Primary outcome: Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2

Time frame: Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange. Number. Unit: percentage of eyes

Measure	Cohort 2 - Baseline (Day 0 Pre Optic Exchange), n = 3	Cohort 2 - Week 1 Post Optic Exchange n = 3	Cohort 2 - Month 1 Post Optic Exchange n = 3
20/20 Snellen or Better	33.3	100.0	66.7
20/25 Snellen or Better	66.7	100.0	100.0
20/32 Snellen or Better	100.0	100.0	100.0
20/40 Snellen or Better	100.0	100.0	100.0
Worse than 20/40 Snellen	0.0	0.0	0.0

Population analysed: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.

Adverse events

Time frame: Adverse events (AEs) were collected from time of consent to study exit: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-Ocular	0 of 78 (0%)	0 of 78 (0%)	0 of 78
Ocular	0 of 100 (0%)	12 of 100 (12%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cataract

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus

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

Questions about this trial

What is this clinical trial studying?

A study testing Harmoni Modular Intraocular Lens and Optic Exchange in people with Cataract and Aphakia, run by ClarVista Medical.

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 3 inclusion and 6 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

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 5 Jan 2021). 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?

Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 (time frame: Day 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03681886.

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 5 Jan 2021.