Cataract
Conditions
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.
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)
Interventions
DEVICEFemto LDV Z8
Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification
DEVICEManual 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
Sponsors
Ziemer Ophthalmic Systems AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 68 |
| 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 | 62 |
| Total | 130 |
Baseline characteristics
| Characteristic | Manual Capsulorhexis&Lens Fragmentation | Femto LDV Z8 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 57 Participants | 60 Participants | 117 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 8 Participants | 13 Participants |
| Age, Continuous | 69.6 years | 70.4 years | 70 years |
| Region of Enrollment Switzerland | 62 participants | 68 participants | 130 participants |
| Sex: Female, Male Female | 37 Participants | 35 Participants | 72 Participants |
| Sex: Female, Male Male | 25 Participants | 33 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 62 |
| other Total, other adverse events | 1 / 68 | 2 / 62 |
| serious Total, serious adverse events | 0 / 68 | 0 / 62 |
Outcome results
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.
Time frame: day of surgery
Population: effective phaco time
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femto LDV Z8 | Effective Phaco Time (EPT) | 1.48 EPT | Standard Deviation 1.8 |
| Manual Capsulorhexis&Lens Fragmentation | Effective Phaco Time (EPT) | 2.3 EPT | Standard Deviation 2.41 |
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.
Time frame: during surgery
Population: Participants were classified as 'easy' or as 'slight resistance' in terms of ease of phacoemulsification.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Femto LDV Z8 | Ease of Phacoemulsification | Classification - slight resistance | 2 Participants |
| Femto LDV Z8 | Ease of Phacoemulsification | Classification - easy | 66 Participants |
| Manual Capsulorhexis&Lens Fragmentation | Ease of Phacoemulsification | Classification - easy | 59 Participants |
| Manual Capsulorhexis&Lens Fragmentation | Ease of Phacoemulsification | Classification - slight resistance | 3 Participants |
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.
Time frame: during surgery
Population: In all cases, the capsulotomy was categorized as a complete treatment pattern
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Femto LDV Z8 | Number of Participants With Complete Treatment Pattern | 68 Participants |
| Manual Capsulorhexis&Lens Fragmentation | Number of Participants With Complete Treatment Pattern | 62 Participants |
Other Pre-specified
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.
Time frame: during follow-up after 1 and 12 days, 4, 8 and 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Femto LDV Z8 | Number of Participants With Reported Complications | 1 Participants |
| Manual Capsulorhexis&Lens Fragmentation | Number of Participants With Reported Complications | 2 Participants |