Cataract Surgery: Femto LDV Z8 Versus Conventional

Cataract Clinical Trial

— COMFORT  

Official title:

A Single Centre Randomized Eye Study to Compare the Performance and Safety of Femtosecond Laser-assisted Cataract Procedures With Conventional Ultrasound-assisted Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351271
• Other study ID #: FL5940-0996
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 28, 2017

Study information

• Verified date: September 2019
• Source: Ziemer Ophthalmic Systems AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cataract Surgery according to conventional procedure, with the exception of two steps (Capsulotomy and Lens Fragmentation) which are performed with a Femtosecond Laser in the study group. Used equipment for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment (group A) Cataract surgery will be performed conventionally, this means the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification. (group B)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 28, 2017
• Est. primary completion date: December 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

• 50 years of age or older

• Willing and able to return for scheduled follow-up examinations

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Femto LDV Z8
Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification
• Manual capsulorhexis&lens fragmentation
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziemer Ophthalmic Systems AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Reported Complications	Safety will be assessed by evaluating observed and/or reported device and non-device related Adverse Events and/or Adverse Device Effects between treatment intervention groups A and B. No serious adverse events were reported. One AE in the femto group and two in the manual group were reported.	during follow-up after 1 and 12 days, 4, 8 and 12 weeks
Primary	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	Ease of Phacoemulsification	Ease of phacoemulsification was performed as a subjective observation by the surgeon. Four classifications were possible: easy - phacoemulsification was fast and uncomplicated; 'slight resistance' - phacoemulsification encountered some difficulty; 'resistance noted' - phacoemulsification was somewhat complex; 'difficult' - phacoemulsification was difficult and complex to complete.	during surgery
Secondary	Number of Participants With Complete Treatment Pattern	Completeness of capsulotomy is a subjective metric given by the surgeon. Measurements were scaled into the following four categories: 1: complete treatment pattern; 2: micro-adhesion; 3: incomplete treatment pattern; 4: complete pattern but not continuous. "Complete treatment pattern" is considered the best result, "micro adhesion" indicates a minor but manageable problem, "incomplete treatment pattern" indicates a treatable, but more complex suboptimal outcome and "complete treatment but discontinuous pattern" indicates the treatable but suboptimal outcome.	during surgery