COMFORT: Cataract Surgery: Femto LDV Z8 Versus Conventional

• Sponsor: Ziemer Ophthalmic Systems AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02351271
• Collaborator: (none)
• Enrollment: 130
• Arms: 2
• Duration (Months): 24.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Femto LDV Z8; Device: Manual capsulorhexis&lens fragmentation	N/A

Detailed 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)

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Dec 28, 2016
• Actual Study Completion Date: Feb 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Femto LDV Z8 Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification	Device: Femto LDV Z8; Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification; Other Names: Treatment A
Active Comparator: Manual capsulorhexis&lens fragmentation The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification	Device: 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; Other Names: Treatment B

Outcome Measures

Primary Outcome Measures

1. Effective Phaco Time (EPT) [day of surgery]

   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.

Secondary Outcome Measures

1. Ease of Phacoemulsification [during surgery]

   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.

2. Number of Participants With Complete Treatment Pattern [during surgery]

   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.

Other Outcome Measures

1. Number of Participants With Reported Complications [during follow-up after 1 and 12 days, 4, 8 and 12 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ziemer Ophthalmic Systems AG

Investigators

• Principal Investigator: Bojan Pajic, MD, PhD, Augenzentrum ORASIS AG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ziemer Ophthalmic Systems AG
• ClinicalTrials.gov Identifier: NCT02351271
• Other Study ID Numbers: FL5940-0996
• First Posted: Jan 30, 2015
• Last Update Posted: Oct 23, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Arm/Group Title	Femto LDV Z8	Manual Capsulorhexis&Lens Fragmentation
Arm/Group Description	Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification 33 males (48.5%) and 35 females (51.5%) in the FLACS group	The Conventional group acts as a control group with conventional capsulorhexis and 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 25 (40.3%) males and 37 females (59.7%) in the manual group
Period Title: Overall Study
STARTED	68	62
COMPLETED	68	62
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Femto LDV Z8	Manual Capsulorhexis&Lens Fragmentation	Total
Arm/Group Description	Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification 33 males (48.5%) and 35 females (51.5%) in the FLACS group	The Conventional group acts as a control group with conventional capsulorhexis and 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 25 (40.3%) males and 37 females (59.7%) in the manual group	Total of all reporting groups
Overall Participants	68	62	130
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 11.8%	5 8.1%	13 10%
>=65 years	60 88.2%	57 91.9%	117 90%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	70.4	69.6	70
Sex: Female, Male (Count of Participants)
Female	35 51.5%	37 59.7%	72 55.4%
Male	33 48.5%	25 40.3%	58 44.6%
Region of Enrollment (participants) [Number]
Switzerland	68 100%	62 100%	130 100%

Outcome Measures

1. Primary Outcome

Title	Effective Phaco Time (EPT)
Description	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.
Time Frame	day of surgery

Outcome Measure Data

Analysis Population Description

effective phaco time

Arm/Group Title	Femto LDV Z8	Manual Capsulorhexis&Lens Fragmentation
Arm/Group Description	Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification 33 males (48.5%) and 35 females (51.5%) in the FLACS group	The Conventional group acts as a control group with conventional capsulorhexis and 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 25 (40.3%) males and 37 females (59.7%) in the manual group
Measure Participants	68	62
Mean (Standard Deviation) [EPT]	1.48 (1.8)	2.3 (2.41)

2. Secondary Outcome

Title	Ease of Phacoemulsification
Description	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.
Time Frame	during surgery

Outcome Measure Data

Analysis Population Description

Participants were classified as 'easy' or as 'slight resistance' in terms of ease of phacoemulsification.

Arm/Group Title	Femto LDV Z8	Manual Capsulorhexis&Lens Fragmentation
Arm/Group Description	Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification 33 males (48.5%) and 35 females (51.5%) in the FLACS group	The Conventional group acts as a control group with conventional capsulorhexis and 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 25 (40.3%) males and 37 females (59.7%) in the manual group
Measure Participants	68	62
Classification - easy	66 97.1%	59 95.2%
Classification - slight resistance	2 2.9%	3 4.8%

3. Secondary Outcome

Title	Number of Participants With Complete Treatment Pattern
Description	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.
Time Frame	during surgery

Outcome Measure Data

Analysis Population Description

In all cases, the capsulotomy was categorized as a complete treatment pattern

Arm/Group Title	Femto LDV Z8	Manual Capsulorhexis&Lens Fragmentation
Arm/Group Description	Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification 33 males (48.5%) and 35 females (51.5%) in the FLACS group	The Conventional group acts as a control group with conventional capsulorhexis and 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 25 (40.3%) males and 37 females (59.7%) in the manual group
Measure Participants	68	62
Count of Participants [Participants]	68 100%	62 100%

4. Other Pre-specified Outcome

Title	Number of Participants With Reported Complications
Description	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.
Time Frame	during follow-up after 1 and 12 days, 4, 8 and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Femto LDV Z8	Manual Capsulorhexis&Lens Fragmentation
Arm/Group Description	Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification	The Conventional group acts as a control group with conventional capsulorhexis and 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
Measure Participants	68	62
Count of Participants [Participants]	1 1.5%	2 3.2%

Adverse Events

Time Frame	one year and 3 months
Adverse Event Reporting Description	AE and SAE defined same as clinicaltrials.gov. As both interventions are limited to the anterior segment of the eye which is a contained anatomical space, deaths due to the intervention of either study group are considered to be zero. However, for the purpose of this study, all AE, SAE and deaths will be monitored.
Arm/Group Title	Femto LDV Z8		Manual Capsulorhexis&Lens Fragmentation
Arm/Group Description	Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification		The Conventional group acts as a control group with conventional capsulorhexis and 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
All Cause Mortality
	Femto LDV Z8		Manual Capsulorhexis&Lens Fragmentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/62 (0%)
Serious Adverse Events
	Femto LDV Z8		Manual Capsulorhexis&Lens Fragmentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/62 (0%)
Other (Not Including Serious) Adverse Events
	Femto LDV Z8		Manual Capsulorhexis&Lens Fragmentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/68 (1.5%)		2/62 (3.2%)
Eye disorders
Transient IOP rise	1/68 (1.5%)	1	0/62 (0%)	0
herpes zoster	0/68 (0%)	0	1/62 (1.6%)	1
postoperative edema of the optic disk	0/68 (0%)	0	1/62 (1.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.