Trial Outcomes & Findings for Cataract Surgery: Femto LDV Z8 Versus Conventional (NCT NCT02351271)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

130 participants

Primary outcome timeframe

day of surgery

Results posted on

2019-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Femto LDV Z8 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	Manual Capsulorhexis&Lens Fragmentation 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
Overall Study STARTED	68	62
Overall Study COMPLETED	68	62
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cataract Surgery: Femto LDV Z8 Versus Conventional

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Femto LDV Z8 n=68 Participants 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	Manual Capsulorhexis&Lens Fragmentation n=62 Participants 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 n=130 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	60 Participants n=5 Participants	57 Participants n=7 Participants	117 Participants n=5 Participants
Age, Continuous	70.4 years n=5 Participants	69.6 years n=7 Participants	70 years n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	25 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment Switzerland	68 participants n=5 Participants	62 participants n=7 Participants	130 participants n=5 Participants

PRIMARY outcome

Timeframe: day of surgery

Population: effective phaco time

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.

Outcome measures

Outcome measures
Measure	Femto LDV Z8 n=68 Participants 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	Manual Capsulorhexis&Lens Fragmentation n=62 Participants 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
Effective Phaco Time (EPT)	1.48 EPT Standard Deviation 1.8	2.3 EPT Standard Deviation 2.41

SECONDARY outcome

Timeframe: during surgery

Population: Participants were classified as 'easy' or as 'slight resistance' in terms of 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.

Outcome measures

Outcome measures
Measure	Femto LDV Z8 n=68 Participants 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	Manual Capsulorhexis&Lens Fragmentation n=62 Participants 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
Ease of Phacoemulsification Classification - easy	66 Participants	59 Participants
Ease of Phacoemulsification Classification - slight resistance	2 Participants	3 Participants

SECONDARY outcome

Timeframe: during surgery

Population: In all cases, the capsulotomy was categorized as a 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.

Outcome measures

Outcome measures
Measure	Femto LDV Z8 n=68 Participants 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	Manual Capsulorhexis&Lens Fragmentation n=62 Participants 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
Number of Participants With Complete Treatment Pattern	68 Participants	62 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Femto LDV Z8 n=68 Participants 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	Manual Capsulorhexis&Lens Fragmentation n=62 Participants 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
Number of Participants With Reported Complications	1 Participants	2 Participants

Adverse Events

Femto LDV Z8

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Manual Capsulorhexis&Lens Fragmentation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Femto LDV Z8 n=68 participants at risk 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	Manual Capsulorhexis&Lens Fragmentation n=62 participants at risk 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
Eye disorders Transient IOP rise	1.5% 1/68 • Number of events 1 • one year and 3 months 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.	0.00% 0/62 • one year and 3 months 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.
Eye disorders herpes zoster	0.00% 0/68 • one year and 3 months 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.	1.6% 1/62 • Number of events 1 • one year and 3 months 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.
Eye disorders postoperative edema of the optic disk	0.00% 0/68 • one year and 3 months 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.	1.6% 1/62 • Number of events 1 • one year and 3 months 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.

Additional Information

Sarah Moyle

Ziemer Ophthalmic Systems AG

Phone: 970 308 9199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60