Cataract Surgery: Femto LDV Z8 Versus Conventional

NCT02351271 | Completed Results DMC

• 1 other identifier: FL5940-0996
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract surgery.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Effective Phaco Time (EPT)

  Effective Phacoemulsification Time (EPT): EPT for eyes receiving Intervention A being statistically same or lower than EPT for eyes receiving Intervention B at p\<0.05 will be considered positive for superior efficacy of application of FEMTO LDV Z8 over the manual procedure Effective Phaco Time is a unit. It is commonly understood in the area of cataract surgery to be the standard way to describe phaco energy during a procedure over different manufactured phaco devices. Effective phaco time is the total phaco time at 100 percent phaco power. It can be less than the total foot-pedal time. Less EPT indicates proportionately less energy delivered to the eye thereby reducing the side effects of phaco power.

  day of surgery

Secondary Outcomes (2)

• Ease of Phacoemulsification

  during surgery

• Number of Participants With Complete Treatment Pattern

  during surgery

Other Outcomes (1)

• Number of Participants With Reported Complications

  during follow-up after 1 and 12 days, 4, 8 and 12 weeks

Study Arms (2)

Femto LDV Z8

EXPERIMENTAL

Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification

Device: Femto LDV Z8

Manual capsulorhexis&lens fragmentation

ACTIVE COMPARATOR

The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification

Device: Manual capsulorhexis&lens fragmentation

Interventions

Femto LDV Z8 DEVICE

Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification

Also known as: Treatment A

Femto LDV Z8

Manual capsulorhexis&lens fragmentation DEVICE

Control treatment where the capsulorhexis is performed manually and the lens fragmentation is performed by the stop and chop technique with the phaco emulsification device

Also known as: Treatment B

Manual capsulorhexis&lens fragmentation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens Implantation
• Able to co-operate with the docking system for the femtosecond laser
• Clear corneal media
• years of age or older
• Willing and able to return for scheduled follow-up examinations

You may not qualify if:

• Minimal and maximal K-values of the central 3mm zone that differ by more than 5D on a keratometric map of the cornea
• Maximum K-value that exceeds 58D
• Minimal K-value of less than 37D
• Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
• Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
• Manifest Glaucoma+OHT (ocular hypertension), pseudoexfoliation
• Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
• Known sensitivity to planned concomitant medications
• History of lens or zonular instability
• Keratoconus or keratectasia
• Immune compromised or diagnosis of connective tissue disease, clinically sign. atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, RA, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study, in the opinion of the study PI.
• Anterior chamber depth (ACD) \< 1.5 mm or ACD \> 4.8 mm as measured from the corneal endothelium.
• Extensive corneal scarring
• Developmental disability or cognitive impairment (would preclude adequate comprehension of the Informed Consent (IC) form and/or the ability to record the study measurements)
• Concurrent participation in another ophthalmological clinical study

Sponsors & Collaborators

• Ziemer Ophthalmic Systems AG: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Sarah Moyle
• Organization: Ziemer Ophthalmic Systems AG

sarah.moyle@ziemergroup.com

970 308 9199

Study Officials

• Bojan Pajic, MD, PhD

  Augenzentrum ORASIS AG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 30, 2015
• Study Start: February 1, 2015
• Primary Completion: December 28, 2016
• Study Completion: February 28, 2017
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-09