CataractsNCT02974140

Cataract Refractive Suite Study

A study testing Cataract Refractive Suite (CRS) and Standard manual technique in people with Cataracts, run by Alcon, a Novartis Company at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to compare the refractive predictability (prediction error) between the Cataract Refractive Suite (CRS) and standard manual technique at one month post-operative Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataracts
What is being tested?: Cataract Refractive Suite (CRS) and Standard manual technique
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 3 sitesUnited States
Study dates: 2 Mar 2017to 25 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

Diagnosed with bilateral cataracts;
Planned cataract surgery and implantation of ReSTOR +2.5 D multifocal intraocular lens (IOL) in both eyes;
Clear intraocular media, other than cataract, in study eye(s);
Willing and able to complete all required postoperative visits;
Able to comprehend and sign a statement of informed consent;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Significant irregular corneal astigmatism;
History of or current severe dry eyes, retinal/uveal pathology or concurrent ocular disease;
Previous intraocular or corneal refractive surgery, corneal transplant, or retinal detachment;
Any inflammation or edema (swelling) of the cornea;
Pregnant;
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Alcon Investigative Site
Hurst, Texas, 76054
Alcon Investigative Site
Panama City, Florida, 32405
Alcon Investigative Site
Stillwater, Minnesota, 55082

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Randomized Evaluation of Refractive Predictability in Patients With or Without Corneal Astigmatism (Maximum Allowable up to 1.25D) When Using the Cataract Refractive Suite and Standard Manual Techniques

The purpose of this study is to compare the refractive predictability (prediction error) between the Cataract Refractive Suite (CRS) and standard manual technique at one month post-operative

Conditions: Cataracts
Being tested: Cataract Refractive Suite (CRS), Standard manual technique
Medical subject headings: Cataract

What participants receive

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

Cataract Refractive Suite (CRS)Device
Configuration consisting of Verion™ Image Guided System, LenSx® Laser and ORA™ System with VerifEye+™ (with or without VerifEye Lynk), combined for use in surgical pre-op planning and during cataract surgery
Standard manual techniqueProcedure or surgery
Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique

Study groups in NCT02974140
Study group	Role	What they receive
CRS	Experimental	First surgical eye randomized to Cataract Refractive Suite with second surgical eye (fellow eye) assigned to standard manual technique. Second eye surgery conducted within 7-14 days of the first eye surgery. Receives: Device: Cataract Refractive Suite (CRS); Procedure: Standard manual technique
Manual	Active comparator	First surgical eye randomized to standard manual technique with second surgical eye (fellow eye) assigned to Cataract Refractive Suite. Second eye surgery conducted within 7-14 days of the first eye surgery. Receives: Device: Cataract Refractive Suite (CRS); Procedure: Standard manual technique

What is being measured

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

Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1
Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
Measured: Day 20-40 from second implantation

Secondary outcomes (3)

Cumulative Dissipated Energy (CDE)
Cumulative Dissipated Energy (CDE) represents the energy dissipated of the ultrasound tip and infusion sleeve at the incision point during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was expended in the eye. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
Measured: Day 0 (operative day), each eye
Estimated Aspiration Fluid Used During Surgery
Aspiration fluid (amount of fluid used during the removal of the cataractous lens) was measured in milliliters (ml). A lower value indicates less fluid used during the procedure. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
Measured: Day 0 (operative day), each eye
Phaco Aspiration Time Spent During Surgery
Phaco aspiration time (the average time the surgeon took to complete the phacoemulsification) was measured in seconds. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
Measured: Day 0 (operative day), each eye

Timeline

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

2 Mar 201725 Jul 2017

First posted28 Nov 2016 (estimated)
Study start2 Mar 2017
Primary completion25 Jul 2017
Study completion25 Jul 2017

Why it stopped: Management Decision

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.
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: Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02974140
Sponsor's protocol ID: CTK246-P001
Status last verified: Aug 2018
First submitted: 23 Nov 2016
Last updated: 14 Sep 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?

See locations

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All Cataracts trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Randomized Evaluation of Refractive Predictability in Patients With or Without Corneal Astigmatism (Maximum Allowable up to 1.25D) When Using the Cataract Refractive Suite and Standard Manual Techniques
ClinicalTrials.gov ID: NCT02974140
Acronym / sponsor ID: CTK246-P001
Conditions: Cataracts
Study type: Interventional
Recruitment status: TerminatedReason stopped: Management Decision
Enrolment: 39 participants (actual)
Lead sponsor: Alcon, a Novartis CompanyIndustry (pharma, biotech, devices)
Study start: 2 Mar 2017 (actual)
Primary completion: 25 Jul 2017 (actual)
Study completion: 25 Jul 2017 (actual)
First posted: 28 Nov 2016 (estimated)
Results: Posted 14 Sep 2018

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 is to compare the refractive predictability (prediction error) between the Cataract Refractive Suite (CRS) and standard manual technique at one month post-operative

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CRS	Experimental	Device: Cataract Refractive Suite (CRS), Procedure: Standard manual techniqueFirst surgical eye randomized to Cataract Refractive Suite with second surgical eye (fellow eye) assigned to standard manual technique. Second eye surgery conducted within 7-14 days of the first eye surgery.
Manual	Active comparator	Device: Cataract Refractive Suite (CRS), Procedure: Standard manual techniqueFirst surgical eye randomized to standard manual technique with second surgical eye (fellow eye) assigned to Cataract Refractive Suite. Second eye surgery conducted within 7-14 days of the first eye surgery.

Who may qualify

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

Key inclusion criteria (6 listed)

Diagnosed with bilateral cataracts;
Planned cataract surgery and implantation of ReSTOR +2.5 D multifocal intraocular lens (IOL) in both eyes;
Clear intraocular media, other than cataract, in study eye(s);
Willing and able to complete all required postoperative visits;
Able to comprehend and sign a statement of informed consent;

Key exclusion criteria (6 listed)

Significant irregular corneal astigmatism;
History of or current severe dry eyes, retinal/uveal pathology or concurrent ocular disease;
Previous intraocular or corneal refractive surgery, corneal transplant, or retinal detachment;
Any inflammation or edema (swelling) of the cornea;
Pregnant;

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
Cataract Refractive Suite (CRS)Configuration consisting of Verion™ Image Guided System, LenSx® Laser and ORA™ System with VerifEye+™ (with or without VerifEye Lynk), combined for use in surgical pre-op planning and during cataract surgery	Device	CRS, Manual
Standard manual techniqueStandard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique	Procedure or surgery	CRS, Manual

Primary outcome

Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1
Time frame: Day 20-40 from second implantation
Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

3 secondary outcomes

Cumulative Dissipated Energy (CDE)
Time frame: Day 0 (operative day), each eye
Estimated Aspiration Fluid Used During Surgery
Time frame: Day 0 (operative day), each eye
Phaco Aspiration Time Spent During Surgery
Time frame: Day 0 (operative day), each eye

Results and safety

Results posted to the registry on 14 Sep 2018, 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 Study Subjects	39	0

Primary outcome: Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1

Time frame: Day 20-40 from second implantation. Number. Unit: percentage of eyes

Measure	Suite n = 36	Manual n = 36
Value	80.6	69.4

Population analysed: Full Analysis Set with data available

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Surgery through study completion, an average of 1 month.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Suite (Ocular)	1 of 38 (2.6%)	0 of 38 (0%)	0 of 38
Manual (Ocular)	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Nonocular	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
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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, A Novartis Division

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cataract Refractive Suite (CRS) and Standard manual technique in people with Cataracts, run by Alcon, a Novartis Company at 3 sites in United States.

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 6 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: stopped early, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 14 Sep 2018). 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 Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1 (time frame: Day 20-40 from second implantation). 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 NCT02974140.

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 14 Sep 2018; AzTrials last refreshed its copy on 27 Oct 2026.