CataractPhase 3NCT01069172

Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery

A Phase 3 study testing FS Laser Surgery and CCC Surgery in people with Cataract, run by Abbott Medical Optics at 1 site in Dominican Republic.

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

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Cataract
What is being tested?: FS Laser Surgery and CCC Surgery
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteDominican Republic
Study dates: Feb 2010to Aug 2010
Phase: Phase 3
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 50 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able and willing to comply with the treatment/follow-up schedule and requirements
Able to understand and provide written Informed Consent
ETDRS (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected)
Age between 50 and 80 years old
Pupil dilates to at least 7 mm
Subject able to fixate
Grade 1-4 nuclear sclerotic cataract (Lens Opacities Classification System - LOCS III)
Axial length between 22 and 26 mm

Who cannot join

Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
History of prior ocular surgery
History of ocular trauma

Show all 9Show fewer

Co-existing ocular disease affecting vision
History or current use of alpha-1 antagonist medication (e.g., Flomax)
Known sensitivity to planned concomitant medications

Trial locations and contacts

1 site in 1 country.

Dominican Republic1 site

Laser Center
Santo Domingo

Other trials in Dominican Republic

About this study

Official title: A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification

The purpose of this study is to evaluate the safety and efficacy of the OptiMedica Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with cataracts. The safety and efficacy will be compared to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.

Conditions: Cataract
Being tested: FS Laser Surgery, CCC Surgery
Keywords: Cataract, Surgery, cataract extraction, Optical devices, laser
Medical subject headings: Cataract

What participants receive

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

FS Laser SurgeryDevice
Also called OptiMedica Catalys™ Precision Laser System (Catalys System) = femtosecond laser; Alcon Infiniti System = U/S (ultrasound) phacoemulsification system
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery to perform capsulotomy, lens segmentation, and lens softening, which are all part of cataract surgery when this femtosecond laser is used.
CCC SurgeryProcedure or surgery
Also called Alcon Infiniti System = U/S (ultrasound) phacoemulsification system.
Subjects will receive the standard of care for CCC and U/S cataract surgery to facilitate removal of the crystalline lens. CCC is a procedure that is part of cataract surgery.

Study groups in NCT01069172
Study group	Role	What they receive
FS Laser Surgery	Experimental	For femtosecond laser-assisted cataract surgery group (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. If necessary, ultrasound (U/S) phacoemulsification will also be applied to facilitate removal of the crystalline lens during cataract surgery. Receives: Device: FS Laser Surgery
CCC Surgery	Active comparator	For the continuous curvilinear capsulorhexis (CCC) group (CCC Surgery), subjects will receive the standard of care for CCC and U/S phacoemulsification surgery to facilitate removal of the crystalline lens during cataract surgery. Receives: Procedure: CCC Surgery

What is being measured

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

Deviation From Intended Capsulotomy Diameter
Capsulotomy diameter measured during surgery for both the experimental and control groups.
Measured: Day of Surgery

Secondary outcomes (1)

Cumulative Dissipated Energy (CDE)
CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows:
CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4)
0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification.
Measured: Day of Surgery

Timeline

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

Feb 2010Aug 2010

First posted17 Feb 2010 (estimated)
Study startFeb 2010
Primary completionJul 2010
Study completionAug 2010

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01069172
Sponsor's protocol ID: OMC-C-2.0
Status last verified: Aug 2014
First submitted: 13 Feb 2010
Last updated: 4 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification
ClinicalTrials.gov ID: NCT01069172
Acronym / sponsor ID: OMC-C-2.0
Conditions: Cataract
Keywords: Cataract, Surgery, cataract extraction, Optical devices, laser
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Abbott Medical OpticsIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Jul 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 17 Feb 2010 (estimated)
Results: Posted 4 Sep 2014

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: None (open label)
Number of arms: 2

Arm	Type	Receives
FS Laser Surgery	Experimental	Device: FS Laser SurgeryFor femtosecond laser-assisted cataract surgery group (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. If necessary, ultrasound (U/S) phacoemulsification will also be applied to facilitate removal of the crystalline lens during cataract surgery.
CCC Surgery	Active comparator	Procedure: CCC SurgeryFor the continuous curvilinear capsulorhexis (CCC) group (CCC Surgery), subjects will receive the standard of care for CCC and U/S phacoemulsification surgery to facilitate removal of the crystalline lens during cataract surgery.

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Able and willing to comply with the treatment/follow-up schedule and requirements
Able to understand and provide written Informed Consent
ETDRS (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected)
Age between 50 and 80 years old
Pupil dilates to at least 7 mm

Key exclusion criteria (9 listed)

Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
History of prior ocular surgery

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
FS Laser SurgeryAlso: OptiMedica Catalys™ Precision Laser System (Catalys System) = femtosecond laser; Alcon Infiniti System = U/S (ultrasound) phacoemulsification systemThe Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery to perform capsulotomy, lens segmentation, and lens softening, which are all part of cataract surgery when this femtosecond laser is used.	Device	FS Laser Surgery
CCC SurgeryAlso: Alcon Infiniti System = U/S (ultrasound) phacoemulsification system.Subjects will receive the standard of care for CCC and U/S cataract surgery to facilitate removal of the crystalline lens. CCC is a procedure that is part of cataract surgery.	Procedure or surgery	CCC Surgery

Primary outcome

Deviation From Intended Capsulotomy Diameter
Time frame: Day of Surgery
Capsulotomy diameter measured during surgery for both the experimental and control groups.

1 secondary outcome

Cumulative Dissipated Energy (CDE)
Time frame: Day of Surgery

Results and safety

Results posted to the registry on 4 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FS Laser Surgery	30	29
CCC Surgery	30	30

Primary outcome: Deviation From Intended Capsulotomy Diameter

Time frame: Day of Surgery. Mean (Standard Deviation). Unit: μm

Measure	FS Laser Surgery n = 29	CCC Surgery n = 29
Value	26.8 (24.6)	339.1 (248.0)

Population analysed: 29 subjects had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes). Analysis of capsulotomy size was done by eye group.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FS Laser Surgery	2 of 29 (6.9%)	0 of 29 (0%)	Not reported
CCC Surgery	1 of 29 (3.4%)	6 of 29 (20.7%)	Not reported

Limitations and caveats (from the sponsor): This evaluation was performed on a relatively small number of patients; assessment of CDE should be repeated in a larger number of subjects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Juan F Batlle, MD principal investigator

Laser Center

William W Culberston, MD study director

Bascom Palmer Eye Institute

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FS Laser Surgery and CCC Surgery in people with Cataract, run by Abbott Medical Optics at 1 site in Dominican Republic.

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 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 4 Sep 2014. 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 Dominican Republic. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2014). 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?

Deviation From Intended Capsulotomy Diameter (time frame: Day of Surgery). 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 NCT01069172.

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 4 Sep 2014.