CataractsNCT02826421

Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation

A study testing UltraSert Preloaded Delivery System, iTec Preloaded Delivery System and iSert Preloaded Delivery System in people with Cataracts, run by Alcon Research.

Completed

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

Official record

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Trial summary

The purpose of this study is to compare corneal incision size after IOL implantation with the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one manually loaded IOL delivery system). Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataracts
What is being tested?: UltraSert Preloaded Delivery System, iTec Preloaded Delivery System and iSert Preloaded Delivery System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: No sites listed yet
Study dates: 4 Jul 2016to 29 Nov 2016
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 comprehend and sign a statement of informed consent;
Willing and able to complete all required postoperative visits;
Cataract;
Planned cataract removal by phacoemulsification;
Calculated lens power from 18.0 through 27.0 D inclusive;
Preoperative astigmatism <1.0D;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Systemic disease that affects the cornea;
Any inflammation or edema of the cornea;
Previous or planned refractive or corneal surgery during the subject's participation in the study;
Previous corneal transplant;
Previous retinal detachment;
Pregnancy or lactation, current or planned, during the course of the study;

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Current participation in another investigational drug or device study that may confound the results of this investigation;
Any condition observed before or during surgery that in the surgeon's medical opinion may affect the success of the cataract surgery;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Clinical Investigation of Corneal Incision Size After IOL Implantation With Preloaded Delivery Devices and a Manual Delivery Device

Conditions: Cataracts
Being tested: UltraSert Preloaded Delivery System, iTec Preloaded Delivery System, iSert Preloaded Delivery System, Monarch III D Manual IOL Delivery System
Keywords: Intraocular lens
Medical subject headings: Cataract

What participants receive

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

UltraSert Preloaded Delivery SystemDevice
Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject
iTec Preloaded Delivery SystemDevice
Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject
iSert Preloaded Delivery SystemDevice
Includes Model 251 or Model 250 posterior chamber IOL, as selected by the Investigator, intended for long term use over the lifetime of the subject
Monarch III D Manual IOL Delivery SystemDevice
Includes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject

Study groups in NCT02826421
Study group	Role	What they receive
UltraSert Preloaded Delivery System	Experimental	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery Receives: Device: UltraSert Preloaded Delivery System
iTec Preloaded Delivery System	Active comparator	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery Receives: Device: iTec Preloaded Delivery System
iSert Preloaded Delivery System	Active comparator	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery Receives: Device: iSert Preloaded Delivery System
Monarch III D Manual IOL Delivery System	Active comparator	Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery Receives: Device: Monarch III D Manual IOL Delivery System

What is being measured

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

Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)
Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.
Measured: Day 0, operative day

Secondary outcomes (1)

Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)
Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.
Measured: Day 0, operative day

Timeline

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

4 Jul 201629 Nov 2016

First posted11 Jul 2016 (estimated)
Study start4 Jul 2016
Primary completion29 Nov 2016
Study completion29 Nov 2016

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 CataractsStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02826421
Sponsor's protocol ID: ILN296-P001
Status last verified: Jul 2017
First submitted: 5 Jul 2016
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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

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All Cataracts trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation of Corneal Incision Size After IOL Implantation With Preloaded Delivery Devices and a Manual Delivery Device
ClinicalTrials.gov ID: NCT02826421
Acronym / sponsor ID: ILN296-P001
Conditions: Cataracts
Keywords: Intraocular lens
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 4 Jul 2016 (actual)
Primary completion: 29 Nov 2016 (actual)
Study completion: 29 Nov 2016 (actual)
First posted: 11 Jul 2016 (estimated)
Results: Posted 28 Jul 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
UltraSert Preloaded Delivery System	Experimental	Device: UltraSert Preloaded Delivery SystemPreloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
iTec Preloaded Delivery System	Active comparator	Device: iTec Preloaded Delivery SystemPreloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
iSert Preloaded Delivery System	Active comparator	Device: iSert Preloaded Delivery SystemPreloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
Monarch III D Manual IOL Delivery System	Active comparator	Device: Monarch III D Manual IOL Delivery SystemManually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery

Who may qualify

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

Key inclusion criteria (7 listed)

Able to comprehend and sign a statement of informed consent;
Willing and able to complete all required postoperative visits;
Cataract;
Planned cataract removal by phacoemulsification;
Calculated lens power from 18.0 through 27.0 D inclusive;

Key exclusion criteria (9 listed)

Systemic disease that affects the cornea;
Any inflammation or edema of the cornea;
Previous or planned refractive or corneal surgery during the subject's participation in the study;
Previous corneal transplant;
Previous retinal detachment;

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
UltraSert Preloaded Delivery SystemIncludes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject	Device	UltraSert Preloaded Delivery System
iTec Preloaded Delivery SystemIncludes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject	Device	iTec Preloaded Delivery System
iSert Preloaded Delivery SystemIncludes Model 251 or Model 250 posterior chamber IOL, as selected by the Investigator, intended for long term use over the lifetime of the subject	Device	iSert Preloaded Delivery System
Monarch III D Manual IOL Delivery SystemIncludes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject	Device	Monarch III D Manual IOL Delivery System

Primary outcome

Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)
Time frame: Day 0, operative day
Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.

1 secondary outcome

Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)
Time frame: Day 0, operative day

Results and safety

Results posted to the registry on 28 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
UltraSert	22	19
iTec	29	26
iSert	28	26
Monarch III D	30	28

Primary outcome: Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)

Time frame: Day 0, operative day. Mean (Standard Error). Unit: mm

Measure	UltraSert n = 19	iTec n = 26	iSert n = 26
Value	2.35 (0.019)	2.47 (0.016)	2.54 (0.019)

Population analysed: Full Analysis Set

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 31 days). AEs are reported as pretreatment and treatment-emergent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	1 of 114 (0.9%)	0 of 114 (0%)	0 of 114
UltraSert	0 of 19 (0%)	0 of 19 (0%)	0 of 19
iTec	1 of 26 (3.8%)	0 of 26 (0%)	0 of 26
iSert	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Monarch III D	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataracts

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
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Active, not recruitingObservational study
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RecruitingObservational study
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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 Manager, GCRA study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing UltraSert Preloaded Delivery System, iTec Preloaded Delivery System and iSert Preloaded Delivery System in people with Cataracts, run by Alcon Research.

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 7 inclusion and 9 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 2 Jul 2018. 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 28 Jul 2017). 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 Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert) (time frame: Day 0, operative day). 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 NCT02826421.

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 2 Jul 2018.